PlainRecords20/30 INDEFLATOR… and 3 more products
- Reason
- Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- Status
- Ongoing
- Distribution
- US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.
- Enforcement report date
- Jan. 1, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Abbott Vascular Inc
- Reason
- Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- Distribution pattern
- US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.”20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon., FDA enforcement report, 2025-01-01. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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: Syringe, Balloon Inflation
Distributed in (FDA's record): Alabama Arizona Arkansas California Colorado Connecticut District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maryland Massachusetts Michigan Mississippi Missouri Montana Nebraska Nevada New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Tennessee Texas Utah Virginia Washington Wisconsin
4 products in this recall
20/30 INDEFLATOR…
- Product
- 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
- Quantity
- 1,418
- Codes and lots
- UDI-DI: 08717648013591, Lots: 60418466, 60418467, 60418468
- Recall started
- Nov. 6, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Syringe, Balloon Inflation
- Root cause (FDA)
- Component change control
- What the company told customers
- On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902
- Recall number
- Z-0730-2025
20/30 Priority Pack Accessory Kit/.096 RHV…
- Product
- 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
- Quantity
- 3,673
- Codes and lots
- UDI-DI: 08717648013614, Lots: 60538750, 60538751, 60539113, 60545329
- Recall started
- Nov. 6, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Syringe, Balloon Inflation
- Root cause (FDA)
- Component change control
- What the company told customers
- On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902
- Recall number
- Z-0731-2025
20/30 Priority Pack Accessory Kit w/Copilot…
- Product
- 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
- Quantity
- 23,407
- Codes and lots
- UDI-DI: 08717648013973, Lots: 60516923, 60553232, 60553233, 60556003, 60556008, 60556009, 60556011, 60556012, 60556014, 60557297, 60559370, 60559371, 60559374, 60559375, 60559376, 60561751, 60561752, 60561753, 60561754, 60561755
- Recall started
- Nov. 6, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Syringe, Balloon Inflation
- Root cause (FDA)
- Component change control
- What the company told customers
- On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902
- Recall number
- Z-0732-2025
20/30 Priority Pack Kit/.115 RHV…
- Product
- 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
- Quantity
- 4,975
- Codes and lots
- UDI-DI: 08717648015274, Lots: 60564920, 60564933, 60566431, 60566432, 60566433, 60566667
- Recall started
- Nov. 6, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Syringe, Balloon Inflation
- Root cause (FDA)
- Component change control
- What the company told customers
- On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902
- Recall number
- Z-0733-2025
This recall among the others
- FDA's enforcement report came 56 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).
- Abbott Vascular: 3 other recalls or notices on this site in the three years before this one (from Jan. 2, 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-0730-2025, Z-0731-2025, Z-0732-2025, Z-0733-2025. 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-0730-2025, Jan. 1, 2025. "20/30 INDEFLATOR… and 3 more products." PlainRecords, https://plainrecords.com/recall/device/z-0730-2025/ (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