PlainRecordsFDA · Medical device recall
Medtronic Pipeline Vantage Embolization Device with Shield Technology… and 1 more product
- Reason
- Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month…
- Status
- Ongoing
- Distribution
- Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign)…
- Enforcement report date
- March 12, 2025
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Micro Therapeutics, Inc.
- Reason
- Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
- Distribution pattern
- Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign) countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Republic Of Moldova, Montenegro, Morocco, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam
What this record is about
A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.
“Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age”Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50, FDA enforcement report, 2025-03-12. The caption is the record's own words.
The picture shows the kind of thing the record is about (a part, a product, a package), not the product itself; the ring marks it. Nothing in it is a claim beyond the record's own words below.
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
FDA device name: Intracranial Aneurysm Flow Diverter
Distributed in (FDA's record): Alabama Alaska Arizona Arkansas California Colorado Connecticut District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Washington West Virginia Wisconsin and nationwide
2 products in this recall
Medtronic Pipeline Vantage Embolization Device with Shield Technology…
- Product
- Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50
- Quantity
- 18,245
- Codes and lots
- All unused devices. Product lots including and between B317266 and B817292. REF/UDI-DI/Lot: PED3-027-350-12/00847536035263, 00847536030770/B409106, B637287, B700548; PED3-027-350-14/00847536035287, 00847536030787/B409234, B700550, B794880; PED3-027-350-16/00847536035294, 00847536030794/B409692, B697962, B700551, B795136, B795142, B809808; PED3-027-350-20/00847536035317, 00847536030817/B410645, B558444, B623124, B672921, B700552, B777630; PED3-027-350-25/00847536035324, 00847536030824/B410718, B672530, B700553, B771934, B771938; PED3-027-400-12/00847536030862, 00847536035362, 00847536036680/B321585, B336094, B349668,B371137, B409814, B414591, B437740, B482271, B594119, B597085, B598465, B612514, B616043, B616052, B647374, B649853, B655648, B658620, B658685, B666385, B666418, B671805, B720634, B720635, B744619, B744621, B756639, B765446, B765448, B780611, B786108; PED3-027-400-14/00847536030879, 00847536035379, 00847536036697/B318079, B335275, B339540, B350391, B364366, B372416, B375523, B410879, B415080, B422400, B438538, B448437, B459694, B460349, B464650, B469525, B474550, B556978, B601007, B608852, B616050, B622657, B625452, B625453, B629552, B683800, B689019, B691414, B698756, B714840, B715051, B721683, B745065, B753732, B763635, B763642, B802419; PED3-027-400-16/00847536030886, 00847536035386, 00847536036703/B326193, B330879, B330881, B357080, B401867, B402034, B403012, B417737, B419736, B420127, B422990, B423257, B426548, B438677, B439156, B439301, B445198, B449040, B449149, B449591, B453559, B454843, B459846, B460523, B465307, B469682, B474417, B560503, B575892, B578340, B597083, B603196, B608221, B611268, B615571, B623135, B623136, B625944, B625945, B672865, B678987, B694225, B694934, B699098, B715043, B721778, B721782, B730828, B730829, B738422, B738423, B739914, B744842, B744860, B766155, B766701, B769315, B776922, B776933, B777378, B791207; PED3-027-400-18/00847536036710/B795091; PED3-027-400-20/00847536030909, 00847536035409, 00847536036727/B318459, B329314, B329316, B338468, B368540, B374265, B380481, B381434, B383600, B384092, B384233, B388982, B391816, B420182, B420318, B423735, B439714, B441852, B449699, B450256, B460915, B461092, B461510, B465420, B470193, B475106, B478030, B485264, B487677, B557537, B565556, B571634, B575122, B576711, B577356, B578341, B631830, B632949, B635238, B636674, B649884, B654937, B657799, B658273, B658540, B659188, B659211, B666546, B671140, B679007, B680109, B692381, B692536, B692916, B693469, B705994, B722574, B722592, B730946, B739972, B741664, B741666, B746709, B752946, B753532, B756807, B756808, B763701, B778174, B778192, B778193, B778534, B778535, B781327, B781347, B791327, B811796; PED3-027-400-25/00847536030916, 00847536035416, 00847536036734/B322422, B394134, B400793, B411501, B415161, B424676, B432804, B442338, B470284, B474964, B481516, B483308, B568647, B576712, B577358, B634985, B636192, B648012, B649383, B661189, B675951, B689989, B704525, B706229, B706230, B709931, B712123, B726423, B741049, B741051, B747537, B747541, B754030, B765519, B776777, B777166, B780003, B780520, B786557; PED3-027-400-30/00847536030923, 00847536035423, 00847536036741/B394830, B401265, B413855, B415343, B415743, B444760, B470728, B475566, B484529, B594121, B603201, B608917, B616555, B622661, B623126, B637143, B675952, B681380, B681596, B711437, B711438, B723555, B731515, B731516, B741809, B764098, B778206, B778207, B798796; PED3-027-450-12/00847536030961, 00847536035461, 00847536036789/B322748, B456666, B471328, B486866, B575963, B601277, B637185, B666423, B703226, B706228, B708791, B711095, B750794, B751129, B758665, B758666, B758667, B794235; PED3-027-450-14/00847536030978, 00847536035478, 00847536036796/B320465, B336565, B340244, B351032, B374880, B404541, B425289, B432042, B462206, B470900, B477408, B481700, B483148, B601181, B604476, B617556, B637191, B669563, B669568, B675953, B692841, B694794, B696125, B697448, B704465, B709288, B711828, B719080, B719084, B741791, B745142, B745143, B751967, B753463, B772618, B814124; PED3-027-450-16/00847536030985, 00847536035485, 00847536036802/B318562, B331383, B331528, B340320, B351038, B374958, B384705, B385273, B395007, B405061, B407737, B424599, B450972, B465971, B471455, B483899, B485855, B535234, B552285, B568744, B571592, B585330, B596585, B622035, B625593, B626044, B628700, B629503, B643420, B659204, B659718, B660616, B661809, B666550, B666589, B668758, B669369, B675954, B682011, B698182, B723071, B723072, B723787, B723791, B735828, B735829, B735830, B746751, B746752, B753483, B757640, B757645, B762226, B762228, B764394, B787789, B789383, B803301; PED3-027-450-18/00847536036819/B797308; PED3-027-450-20/00847536031005, 00847536035508, 00847536036826/B325710, B328706, B328709, B355336, B357077, B357672, B377120, B381729, B389289, B390355, B397986, B419639, B421094, B423116, B425691, B440190, B440356, B440859, B442521, B449796, B450384, B451092, B452205, B461652, B462339, B464094, B480010, B481041, B487030, B549631, B550980, B557508, B569276, B573461, B574475, B584490, B585331, B594727, B632801, B635651, B650035, B651312, B651584, B652220, B669427, B673379, B674005, B681938, B696501, B696960, B700714, B700961, B703735, B705508, B728234, B729519, B732220, B752592, B758912, B758914, B760821, B774880, B776153, B794615, B794620, B798765, B810476, B811668; PED3-027-450-25/00847536031012, 00847536035515, 00847536036833/B319170, B352790, B370633, B395978, B403146, B408241, B419571, B425960, B443719, B453438, B453676, B463202, B467023, B471895, B472002, B488714, B558531, B590206, B596591, B597131, B600999, B604474, B604478, B611115, B613070, B616042, B645444, B645874, B646698, B652027, B654357, B681223, B681901, B693373, B696977, B697584, B699639, B699762, B730899, B751210, B751305, B752452, B759553, B759554, B775532, B800797; PED3-027-450-30/00847536031029, 00847536035522, 00847536036840/B396144, B404416, B411353, B434096, B436536, B535757, B561797, B574352, B616037, B644866, B645276, B651451, B652656, B654460, B658656, B659930, B675955, B688941, B713232, B714797, B714798, B717097, B730298, B731601, B731603, B784372, B785363, B810615, B815818; PED3-027-450-40/00847536031043, 00847536035546, 00847536036864/B353358, B377744, B411399, B448343, B549634, B559739, B615408, B623125, B637017, B675956, B683288, B684783, B699735, B699776, B704439, B710043, B710051, B733018, B761384, B761385, B761386, B764292, B778738, B778836, B786518; PED3-027-500-14/00847536031067, 00847536035577, 00847536036895/B353371, B411952, B425824, B432210, B447358, B455035, B455951, B601160, B603379, B606137, B624428, B637037, B651443, B674478, B675957, B685652, B701387, B706116, B706164, B710564, B710571, B711705, B729531, B764751, B765289, B785958, B790520; PED3-027-500-16/00847536031074, 00847536035584, 00847536036901/B320910, B353996, B375682, B425116, B426932, B432683, B441009, B479353, B536475, B558194, B568648, B622122, B622123, B638485, B638487, B644714, B645376, B647467, B649263, B652167, B652663, B654363, B655727, B683524, B703758, B704315, B704999, B710455, B729572, B730327, B785458, B785792, B785793, B807437, B809811; PED3-027-500-18/00847536036918/B797650; PED3-027-500-20/00847536031098, 00847536035607, 00847536036925/B326325, B331608, B341953, B354635, B370450, B377872, B381636, B386124, B396652, B416028, B426418, B443827, B456058, B457830, B466125, B472700, B476324, B479966, B485115, B566387, B590194, B596594, B603380, B645491, B645898, B645962, B647222, B650050, B651347, B677890, B678397, B678959, B679068, B684999, B695686, B705596, B705610, B707567, B707606, B717655, B727541, B734039, B737927, B737928, B752681, B763087, B772659, B773371, B773372, B779449, B779450, B779633; PED3-027-500-25/00847536031104, 00847536035614, 00847536036932/B354639, B382191, B387287, B396748, B413971, B417560, B472568, B478679, B536229, B570707, B603199, B646445, B648039, B680655, B688975, B689445, B693010, B694374, B695076, B700554, B702913, B720212, B720213, B720231, B747329, B747330, B747332, B751359, B761968, B763427, B800923; PED3-027-500-30/00847536031111, 00847536035621, 00847536036949/B337320, B342643, B358320, B378426, B382386, B382844, B401379, B427074, B428049, B428522, B429875, B435865, B436340, B445405, B452880, B456544, B596584, B598708, B606136, B623128, B655004, B655034, B655744, B663561, B666422, B668512, B669368, B669370, B707244, B728433, B743037, B743038, B743039, B750658, B751192, B752314, B752315, B779538; PED3-027-500-40/00847536031135, 00847536035645, 00847536036963/B319346, B340946, B373012, B373062, B374156, B379194, B397871, B398496, B456742, B457215, B464764, B467126, B473757, B482175, B567777, B573469, B585305, B590192, B677757, B682747, B693594, B701050, B703777, B703949, B707108, B710395, B711021, B711022, B736159, B747948, B749861, B753183, B753184, B762889, B773500; PED3-027-550-16/00847536031166, 00847536035683, 00847536037007/B358321, B369526, B452971, B497779, B575962, B580922, B622743, B623127, B686266, B689577, B707045, B707126, B708154, B708159, B720912, B720913, B739371, B749920, B782490, B806751; PED3-027-550-18/00847536037014/B803199; PED3-027-550-20/00847536035706, 00847536031180, 00847536037021/B412256, B417797, B446018, B454303, B496490, B560727, B565445, B578965, B615897, B623137, B623138, B690738, B691319, B692483, B695336, B713205, B713214, B717726, B731786, B731789, B740657, B741946, B764254, B764286, B766393, B766406, B780554, B781697, B800693, B808083; PED3-027-550-30/00847536031203, 00847536035720, 00847536037045/B397247, B408458, B414706, B416571, B473971, B475784, B479273, B494116, B608410, B611882, B615380, B663584, B666410, B695406, B696119, B697734, B709920, B713734, B713735, B729710, B738501, B738502, B746449, B783057, B783239, B783566; PED3-027-550-40/00847536031227, 00847536035744, 00847536037069/B358931, B378536, B389916, B409027, B433336, B437033, B454059, B493075, B494673, B612534, B615604, B616547, B652056, B654234, B655595, B671064, B672455, B672476, B684986, B704973, B706035, B707059, B717259, B717261, B742095, B750469, B761584, B768849, B771892, B771893, B773963, B778320, B778326, B780176; PED3-027-550-50/00847536031241, 00847536035768, 00847536037083/B397414, B412119, B431531, B435644, B437187, B616028, B637697, B658014, B705133, B717320, B717336, B717341, B724924, B745389, B745405, B745974, B749926, B785200, B785874; PED3-027-600-16/00847536031289, 00847536035805, 00847536037120/B368960, B454127, B603197, B607478, B611280, B611281, B690544, B691908, B693533, B709546, B720780, B732968, B762785, B801322; PED3-027-600-18/00847536037137/B801452; PED3-027-600-20/00847536031302, 00847536035829, 00847536037144/B317266, B338536, B376423, B412355, B446526, B491096, B596581, B608223, B624427, B624430, B681791, B682681, B698133, B701028, B708016, B708642, B709539, B713242, B720316, B720318, B747892, B747893, B761449, B769429, B805791; PED3-027-600-30/00847536031326, 00847536035843, 00847536037168/B339559, B412787, B457289, B467222, B489389, B594600, B597081, B611169, B611170, B626128, B652141, B653242, B654415, B681946, B682043, B701346, B711916, B712145, B719705, B726352, B726417, B728348, B735171, B748081, B748545, B748565, B758585, B808813; PED3-027-600-40/00847536031340, 00847536035867, 00847536037182/B320318, B337325, B360226, B369513, B379020, B419419, B480964, B485981, B485982, B549767, B552409, B559740, B567778, B608855, B618581, B622005, B655601, B655798, B669603, B694091, B695569, B699270, B711618, B716111, B720752, B721600, B742928, B745966, B758046, B758050, B760363, B767594, B790633, B800873; PED3-027-600-50/00847536031364, 00847536035881, 00847536037205/B327190, B332681, B342121, B403885, B415948, B428706, B429330, B433507, B434230, B457419, B557587, B617560, B623582, B626133, B651590, B652749, B653261, B653391, B658476, B658484, B670055, B670398, B673424, B680095, B695531, B703875, B713824, B714234, B726282, B732261, B732262, B732459, B733700, B746625, B758339, B758371, B768841, B783879, B783888, B788852, B790033, B794845
- Recall started
- Jan. 30, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Intracranial Aneurysm Flow Diverter
- Root cause (FDA)
- Device Design
- What the company told customers
- On 1/30/2025, Medtronic Neurovascular mailed "Urgent Safety and Labeling Notification" recall notices to healthcare professions who were asked to do the following: Removal (retrieval) is isolated to unused inventory of the Pipeline Vantage 027 devices: 1) Remove and quarantine all unused impacted products in your inventory. 2) Return the impacted products to firm. Firm representative can assist with identifying suitable replacement product. Correction of Instructions for Use applies to Pipeline Vantage 021 devices: The key updates are: 1) Appropriate device diameter and length selection to account for complex anatomy. 2) Techniques to deploy Pipeline Vantage compared to Pipeline Shield using a balance of device tension and compression to achieve adequate wall apposition and landing around curves. 2) Warnings about the consequences of incomplete wall apposition and suboptimal deployment and the increased risk of braid deformation in females, especially in females less-than-or-equal-to 45 years of age. Updated IFU M067713CDOC2 Rev. A (01/2025) was sent with the notice and can be found at: https://manuals.medtronic.com/manuals/ Share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Please maintain a copy of this letter for your records and the records of your patients. Complete and return the customer confirmation form via email to neuro.quality@medtronic.com Questions can be directed to the firm at rs.nvquality@medtronic.com or call at 1(800) 633-8766 (US Toll free) or (763) 514-4000 (Worldwide), available 24 hours a day, 7 days a week.
- Recall number
- Z-1245-2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology…
- Product
- Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
- Quantity
- 7820
- Codes and lots
- Instructions for Use, Version: Rev. A (01/2024). REF/UDI-DI/Lot: PED3-021-350-16/00847536030701, 00847536035195, 00847536036529/B317460, B327449, B335184, B340948, B349032, B389162, B392918, B424454, B430015, B495821, B497938, B547396, B550307, B551615, B559033, B603377, B623564, B656863, B656887, B658904, B692346, B715057, B715058, B715541, B726894, B735821, B735823, B756029, B756030, B760210, B760211, B768202, B768387, B769453, B770633, B807494; PED3-021-250-14/00847536030411, 00847536034907, 00847536036239/B317936 B332767, B333492, B333536, B334545, B376967, B388041, B391185, B399354, B416713, B431395, B452416, B457963, B467691, B476239, B564173, B564970, B574472, B580923, B629372, B630998, B670305, B673035, B699576, B707568, B709193, B736698, B736893, B739090, B739091, B795110, B796586, B800827, B801770; PED3-021-350-20/00847536030725, 00847536035218, 00847536036543/B319436, B336571, B379993, B383427, B389708, B400103, B400599, B403612, B407062, B415211, B446722, B483987, B490972, B492403, B494049, B552487, B559741, B591782, B591864, B592074, B622656, B626023, B648708, B684905, B715692, B719565, B719567, B719659, B726923, B728926, B735667, B756330, B765053, B768231, B770237, B770248, B792630; PED3-021-250-20/00847536030442, 00847536034938, 00847536036260/B321465, B337378, B360749, B371070, B412868, B467843, B477487, B488713, B548244, B557602, B644034, B673388, B679822, B684208, B686727, B695486, B698571, B703035, B708080, B709204, B711078, B746067, B757056, B757060, B761030, B771498, B775215, B789892, B790055; PED3-021-300-16/00847536030541, 00847536035034, 00847536036369/B321725, B338497, B405720, B418200, B570723, B574473, B603375, B604477, B656277, B658580, B659806, B666425, B681289, B691752, B699606, B703209, B707982, B711365, B725679, B736659, B738114, B769551, B769582, B798864; PED3-021-300-20/00847536030565, 00847536035058, 00847536036383/B322263, B336066, B347327, B376257, B405892, B414535, B458672, B458776, B469040, B490920, B495292, B563197, B607500, B607501, B635214, B636992, B656299, B656355, B657960, B668529, B678482, B680045, B681190, B712110, B712111, B718522, B720923, B725457, B732895, B735956, B737156, B737367, B748272, B748683, B749541, B775230, B778774, B780044; PED3-021-275-12/00847536030466, 00847536034952, 00847536036284/B323044, B383016, B391275, B399486, B454385, B468406, B623580, B623583, B624424, B657776, B666498, B669520, B670179, B670226, B710976, B743820, B743822, B754659, B762034, B768199, B798851; PED3-021-275-16/00847536030480, 00847536034976, 00847536036307/B323046, B361987, B406342, B414102, B458076, B468915, B477868, B558538, B562688, B563304, B603078, B654235, B656399, B657059, B666486, B669610,B670343, B677246, B699308, B736874, B743098, B755194, B755196, B755673, B769461, B771317, B775167, B775168; PED3-021-325-12/00847536030602, 00847536035096, 00847536036420/B324297, B407597, B418843, B494876, B561787, B592073, B623579, B629046, B676507, B678997, B716220, B741395, B751748, B787015, B787017; PED3-021-325-14/00847536030619, 00847536035102, 00847536036437/B324809, B347993, B362685, B459598, B558177, B563209, B575964, B580901, B628946, B675724, B678948, B681904, B714342, B714344, B733352, B733353, B769593, B790478; PED3-021-325-16/00847536030626, 00847536035119, 00847536036444/B324954, B339033, B371691, B418451, B460439, B495941, B603378, B604475, B623578, B624422, B660509, B664402, B666503, B667510, B667920, B668523, B680717, B681747, B733912, B739722, B739723, B739724, B746618, B794191, B794192; PED3-021-325-20/00847536030640, 00847536035133, 00847536036468/B325613, B371743, B418905, B421650, B463895, B487451, B495368, B591952, B591955, B644630, B644769, B644809, B657857, B659135, B659138, B659243, B684852, B716733, B716735, B741305, B741316, B741321, B787131; PED3-021-250-12/00847536030404, 00847536034891, 00847536036222/B326236, B335270, B387931, B390988, B394283, B421249, B477292, B497244, B578963, B664457, B666521, B667945, B669726, B696189, B719158, B724199, B724200, B724764, B741102, B746521, B764797, B764798, B787764, B787765, B787766, B793905; PED3-021-300-14/00847536030534, 00847536035027, 00847536036352/B327828, B335957, B346789, B393640, B399293, B403772, B456576, B547554, B568649, B575299, B631125, B631126, B649258, B650123, B652886, B657773, B683152, B711496, B712157, B712158, B732804, B732807, B754755, B754756, B754757, B760951, B760953, B768142, B769947, B789256; PED3-021-250-16/00847536030428, 00847536034914, 00847536036246/B328095, B416673, B452284, B478579, B494048, B565441, B573470, B575302, B628868, B628869, B630965, B656206, B666535, B667323, B668743, B739139, B739405, B739408, B754155, B754886, B754888, B755651, B794406, B794408, B794426; PED3-021-300-12/00847536030527, 00847536035010, 00847536036345/B338969, B345449, B346121, B361988, B405158, B418358, B454923, B551608, B561782, B562698, B563303, B575894, B677108, B677319, B699289, B703245, B718483, B718491, B739905, B744728, B760716, B766588; PED3-021-275-14/00847536030473, 00847536034969, 00847536036291/B343142, B361366, B379727, B429213, B448933, B452378, B461124, B601345, B607550, B624425, B626121, B678023, B680119, B711192, B713287, B724745, B744169, B744175, B744176, B770971, B770988; PED3-021-350-14/00847536030695, 00847536035188, 00847536036512/B349031, B372357, B388981, B391924, B399969, B421758, B445867, B491603, B492310, B497318, B596593, B629649, B630549, B631109, B670495, B678371, B679957, B713023, B713796, B740630, B740631, B742526, B743935, B753618; PED3-021-350-25/00847536030732, 00847536035225, 00847536036550/B364361, B393438, B403082, B419021, B422233, B430531, B437842, B447224, B488266, B616574, B624414, B629444, B629660, B672265, B672892, B673364, B717131, B717132, B724110, B733587, B733590, B741976, B761681, B768780, B771211, B772034, B773456, B773457; PED3-021-350-12/00847536030688, 00847536035171, 00847536036505/B368529, B406425, B419491, B490325, B496666, B497114, B611908, B615889, B616569, B643508, B643509, B644619, B657109, B658427, B659171, B690687, B715610, B715612, B716621, B742378, B746455, B787264; PED3-021-250-10/00847536030398, 00847536036215, 00847536034884/B387475, B390553, B427939, B490270, B575123, B578342, B628755, B654233, B666402, B670376, B693553, B707945, B711113, B740699, B764024, B764025, B766116, B769419, B797931, B801945; PED3-021-275-20/00847536030503, 00847536034990, 00847536036321/B391792, B398628, B418296, B452832, B461730, B497830, B548241, B567772, B655966, B656945, B666505, B671729, B677211, B679094, B680758, B693403, B699179, B711385, B725638, B725639, B736012, B736612, B737225, B751998, B756411, B797986; PED3-021-350-18/00847536036536/B798906; PED3-021-325-18/00847536036451/B800239; PED3-021-275-18/00847536036314/B805162; PED3-021-250-18/00847536036253/B805488; PED3-021-300-18/00847536036376/B807417
- Recall started
- Jan. 30, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Intracranial Aneurysm Flow Diverter
- Root cause (FDA)
- Device Design
- What the company told customers
- On 1/30/2025, Medtronic Neurovascular mailed "Urgent Safety and Labeling Notification" recall notices to healthcare professions who were asked to do the following: Removal (retrieval) is isolated to unused inventory of the Pipeline Vantage 027 devices: 1) Remove and quarantine all unused impacted products in your inventory. 2) Return the impacted products to firm. Firm representative can assist with identifying suitable replacement product. Correction of Instructions for Use applies to Pipeline Vantage 021 devices: The key updates are: 1) Appropriate device diameter and length selection to account for complex anatomy. 2) Techniques to deploy Pipeline Vantage compared to Pipeline Shield using a balance of device tension and compression to achieve adequate wall apposition and landing around curves. 2) Warnings about the consequences of incomplete wall apposition and suboptimal deployment and the increased risk of braid deformation in females, especially in females less-than-or-equal-to 45 years of age. Updated IFU M067713CDOC2 Rev. A (01/2025) was sent with the notice and can be found at: https://manuals.medtronic.com/manuals/ Share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Please maintain a copy of this letter for your records and the records of your patients. Complete and return the customer confirmation form via email to neuro.quality@medtronic.com Questions can be directed to the firm at rs.nvquality@medtronic.com or call at 1(800) 633-8766 (US Toll free) or (763) 514-4000 (Worldwide), available 24 hours a day, 7 days a week.
- Recall number
- Z-1246-2025
This recall among the others
- FDA's enforcement report came 41 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Micro Therapeutics: 3 other recalls or notices on this site in the three years before this one (from March 13, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1245-2025, Z-1246-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1245-2025, March 12, 2025. "Medtronic Pipeline Vantage Embolization Device with Shield Technology… and 1 more product." PlainRecords, https://plainrecords.com/recall/device/z-1245-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections