FDA · Medical device recall

ANGIOGUARD RX / XP Emboli Capture Guidewire System… and 13 more products

May 17, 2023 Class I

Date: May 17, 2023
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
Filed by: Cordis US Corp
Reason: There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Distribution pattern: Worldwide distribution.

14 products in this recall

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
Quantity: 283 units
Codes and lots: UDI/DI 20705032053508; Lot Numbers: 35262517, 35263334, 35264204, 35264222, 35265345.
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1483-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
Quantity: 684 units
Codes and lots: UDI/DI 20705032054802; Lot Numbers: 35264208, 35264212, 35265329, 35265654, 35265649, 35265667.
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1484-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
Quantity: 471 units
Codes and lots: UDI/DI 20705032056745; Lot Numbers: 35263328, 35264207, 35264213, 35264216, 35265393, 35265648, 35265659
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1485-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
Quantity: 54 units
Codes and lots: UDI/DI 20705032056851; Lot Numbers: 35265661
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1486-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
Quantity: 146 units
Codes and lots: UDI/DI 20705032056943; Lot Numbers: 35265335, 35264202
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1487-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
Quantity: 43 units
Codes and lots: UDI/DI 20705032056790; Lot Numbers: 35265492
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1488-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Quantity: 40 units
Codes and lots: UDI/DI 20705032054789; Lot Numbers: 35264223
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1489-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
Quantity: 56 units
Codes and lots: UDI/DI 20705032053492; Lot Numbers: 35265339, 35265670
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1490-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
Quantity: 1087 units
Codes and lots: UDI/DI 20705032054772; Lot Numbers: 35264217, 35264226, 35265330, 35265344, 35265381, 35265641, 35265652, 35265655, 35264205, 35264210, 35264214, 35265340, 35265341, 35265394, 35265643
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1491-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
Quantity: 1058 units
Codes and lots: UDI/DI 20705032056714; Lot Numbers: 35264218, 35264224, 35264806, 35265342, 35265343, 35265382, 35265383, 35265646, 35265656, 35265658, 35264206, 35265645, 35265653
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1492-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
Quantity: 385 units
Codes and lots: UDI/DI 20705032056820; Lot Numbers: 35264219, 35265391, 35265392, 35265399, 35265668, 35265660
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1493-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
Quantity: 27 units
Codes and lots: UDI/DI 20705032056738; Lot Numbers: 35265658, 35264211, 35264225, 35265647
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1494-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
Quantity: N/A
Codes and lots: UDI/DI 20705032054796; Lot Numbers: 35265644
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1495-2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System…

Product: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
Quantity: N/A
Codes and lots: UDI/DI 20705032056929; Lot Numbers: 35267611
Recall started: March 24, 2023
Device type: Temporary Carotid Catheter For Embolic Capture
Root cause (FDA): Vendor change control
What the company told customers: The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Recall number: Z-1496-2023

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1483-2023, Z-1484-2023, Z-1485-2023, Z-1486-2023, Z-1487-2023, Z-1488-2023, Z-1489-2023, Z-1490-2023 and others. The agency record governs; check it and the company before acting.

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