Recall Z-0928-2013— Sorin Group USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2013-01-28, terminated 2015-12-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Isoline defibrillation leads distributed may have internal insulation breach..
- Recalling firm
- Sorin Group USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-28
- Terminated
- 2015-12-09
- Firm location
- Arvada, CO, United States
Product description
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
Reason for recall
Isoline defibrillation leads distributed may have internal insulation breach.
Data sourced from openFDA. This site is unofficial and independent of the FDA.