Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

20/30 INDEFLATOR Recalled by Abbott Vascular Inc Due to Inflation Device used during cardiovascular procedures may leak...

Date: November 6, 2024
Company: Abbott Vascular Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Vascular Inc directly.

Affected Products

20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.

Quantity: 1,418

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 39 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MS, MO, MT, NE, NV, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, DC

Affected (39 states)Not affected

About Abbott Vascular Inc

Abbott Vascular Inc has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report