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).
FDA Recall Z-0731-2025 · Posted 2024-12-20
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Recalling FirmAbbott Vascular Inc
Recall StatusOpen, Classified
Product CodeMAV
Date Initiated2024-11-06
Product Quantity3,673
Reason for Recall
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.
Firm Action
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
Root Cause
Component change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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