Abbott Vascular Inc: Device Recall

Recall #Z-0733-2025 · 11/06/2024

Class II: Risk

Recall Details

Recall Number: Z-0733-2025
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: 4,975

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 Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.

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

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.
Class II: Risk 11/06/2024

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.
Class II: Risk 11/06/2024

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.

View all recalls by Abbott Vascular Inc →

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.