Reported Nov 27, 2013 · Terminated
ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in…
Medtronic Vascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular · 35-37A Cherry Hill Drive · Danvers, MA · 01923-2565
Is this the product you have?
- ATTAIN HYBRID¿ Guide Wire
- ModelsGWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature
- Lot codes and dates
00067523710006752383000675238500067599370006759939000675994100067697720006781453000678145400067814550006808160000680816100068081640006808165000680816600068081670006831243000684086600068408780006840879000686669400068666960006866697000687368800068736920006873694
- Amount recalled
- 1674
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Stop using this product now
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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