Recall Z-0265-2014— Medtronic Vascular

Name: FDA recall Z-0265-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-21

Class I · Terminated

Class I FDA medical device recall by Medtronic Vascular, initiated 2013-10-21, terminated 2014-12-15. It names one FDA 510(k) clearance: K063210. Product: 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.. Reason: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire..

Recalling firm: Medtronic Vascular
Classification: Class I
Status: Terminated
Initiated: 2013-10-21
Terminated: 2014-12-15
Firm location: Danvers, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K063210 — ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management·cleared 2007-03-15

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

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.

Reason for recall

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

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