Abbott Vascular Inc: Device Recall
Recall #Z-0731-2025 · 11/06/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0731-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Abbott Vascular Inc
- Status
- Ongoing
- Date Initiated
- 11/06/2024
- Location
- Temecula, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,673
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.
Product Description
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).
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.
Other Recalls by Abbott Vascular Inc
- Class II: Risk 11/06/2024
- Class II: Risk 11/06/2024
- Class II: Risk 11/06/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.