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Recall Observatory FDA recall evidence

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

January 28, 2013

Class II

Product summary

Firm
Sorin Group USA, Inc.
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

    reason.no_named_rule · v1.0.0

    Isoline defibrillation leads distributed may have internal insulation breach.