Abbott Vascular Inc: Medical Device Recall in 2025 - (Recall #: Z-0732-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

Product Classification:

Class II

Date Initiated: November 6, 2024
Date Posted: January 1, 2025
Recall Number: Z-0732-2025
Event ID: 95707
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.

Status: Ongoing
Product Quantity: 23,407
Code Information:

UDI-DI: 08717648013973, Lots: 60516923, 60553232, 60553233, 60556003, 60556008, 60556009, 60556011, 60556012, 60556014, 60557297, 60559370, 60559371, 60559374, 60559375, 60559376, 60561751, 60561752, 60561753, 60561754, 60561755

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.

Voluntary or Mandated:

Voluntary: Firm initiated