Class II — Potential Health Hazard

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

Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB) Recalled by Arrow International Inc Due to Potential for a leak between the catheter and...

Date: November 8, 2013
Company: Arrow International Inc
Status: Terminated
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 Arrow International Inc directly.

Affected Products

Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

Quantity: 166 units

Why Was This Recalled?

Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Arrow International Inc

Arrow International Inc has 431 total recalls tracked by RecallDetector.

Related Recalls

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