Sorin Group USA, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0928-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 28, 2013

Date Posted: March 20, 2013

Recall Number: Z-0928-2013

Event ID: 64344

Reason for Recall:

Isoline defibrillation leads distributed may have internal insulation breach.

Status: Terminated

Product Quantity: 1376 Isoline leads

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.

Voluntary or Mandated:

Voluntary: Firm initiated