Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

ATTAIN HYBRID¿ Guide Wire Recalled by Medtronic Vascular Due to Potential for PTFE (polytetrafluroethylene) coating to delaminate and...

Date: October 21, 2013
Company: Medtronic Vascular
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 Medtronic Vascular directly.

Affected Products

ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.

Quantity: 1674

Why Was This Recalled?

Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Vascular

Medtronic Vascular has 211 total recalls tracked by RecallDetector.

Related Recalls

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