Recall Z-0731-2025— Abbott Vascular Inc

Name: FDA recall Z-0731-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-06

Class II · Ongoing

Class II FDA medical device recall by Abbott Vascular Inc, initiated 2024-11-06. It names one FDA 510(k) clearance: K961471. Product: 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).. Reason: 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..

Recalling firm: Abbott Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-11-06
Firm location: Temecula, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K961471 — INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)Advanced Cardiovascular Systems, Inc.·cleared 1996-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.