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U.S. Department of Health and Human Services

Class 2 Device Recall Implantable Defibrillation Lead

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 Class 2 Recall
Implantable Defibrillation Lead
see related information
Date Posted March 08, 2013
Recall Status1 Open
Recall Number Z-0928-2013
Recall Event ID 64344
Premarket Approval
PMA Number
P980049
Product Classification Defibrillator, Implantable, Dual-Chamber - Product Code MRM
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
Code Information Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
Recalling Firm/
Manufacturer
Sorin Group USA, Inc.
14401 W 65th Way
Arvada, Colorado 80004
For Additional Information Contact Steven C. Smith
303-467-6306
Manufacturer Reason
for Recall
Isoline defibrillation leads distributed may have internal insulation breach.
FDA Determined
Cause 2
DESIGN: Device Design
Action Sorin C.R.M., srl sent an Urgent Medical Device Field Safety Notice dated January28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return any unused products by certified mail with signed acknowledgment form, patients should continue to be monitored by their physician field reps during notification visit, and customers should make sure all personnel involved in the management of patients implanted with affected product are aware of the information described in the Field Safety Notice. Customers with questions should contact their local Sorin representative at 1-610-304-9728. For questions regarding this recall call 303-467-6222.
Quantity in Commerce 1376 Isoline leads
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MRM and Applicant = ELA MEDICAL, INC.
PMAs with Product Code = MRM and Applicant = SORIN CRM USA, INC.
PMAs with Product Code = MRM and Applicant = SORIN GROUP CRM USA, INC
PMAs with Product Code = MRM and Applicant = SORIN GROUP ITALIA S.R.L.
PMAs with Product Code = MRM and Applicant = SORIN GROUP- CRM
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