Devices

Device Recall Implantable Defibrillation Lead

Model / Serial
Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
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.
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
Manufacturer
Sorin Group USA, Inc.
1 Event
- Recall of Device Recall Implantable Defibrillation Lead

Manufacturer

Sorin Group USA, Inc.

Manufacturer Address
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA

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