Reported Mar 20, 2013 · Terminated
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for…
Sorin Group USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004
Is this the product you have?
- Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
- Lot codes and dates
- Models
2CR52CR6 and 2CT6Distributed From 03/19/08 To 01/21/13
- Models
- Amount recalled
- 1376 Isoline leads
Where it was sold
- Nationwide
Why it was recalled
Isoline defibrillation leads distributed may have internal insulation breach.
This product could cause temporary or reversible health problems — stop using it.
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