FDA Device recall Z-0928-2013
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia…
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia… by Sorin Group Usa, citing isoline defibrillation leads distributed may have internal insulation breach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0928-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-28 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sorin Group Usa |
| Distribution | US |
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.
Identifiers
| code_info | Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0928-2013%22
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