Abbott Vascular Inc: Medical Device Recall in 2025 - (Recall #: Z-0731-2025)

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/.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).

Product Classification:

Class II

Date Initiated: November 6, 2024

Date Posted: January 1, 2025

Recall Number: Z-0731-2025

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: 3,673

Code Information:

UDI-DI: 08717648013614, Lots: 60538750, 60538751, 60539113, 60545329

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