Device 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
Z-0928-2013
Product summary
- Event
- Event 64344
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1376 Isoline leads
- Official record key
device-enforcement:Z-0928-2013
Official wording
Reason: Isoline defibrillation leads distributed may have internal insulation breach.
Code information: Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
Distribution pattern: Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom.
Derived failure modes
-
Unknown
Isoline defibrillation leads distributed may have internal insulation breach.