Class II — Potential Health Hazard

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

Distal Access Catheters - 044 - 115 cm: Finished Good Recalled by Concentric Medical Inc Due to One Distal Access Catheter intended for distribution in...

Date: August 19, 2015
Company: Concentric Medical 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 Concentric Medical Inc directly.

Affected Products

Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.

Quantity: 1

Why Was This Recalled?

One Distal Access Catheter intended for distribution in Korea, was found at a US location.

Where Was This Sold?

This product was distributed to 1 state: KY

Affected (1 state)Not affected

About Concentric Medical Inc

Concentric Medical Inc has 5 total recalls tracked by RecallDetector.

Related Recalls

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