| Class 2 Device Recall Implantable Defibrillation Lead | |
Date Initiated by Firm | January 28, 2013 |
Date Posted | March 08, 2013 |
Recall Status1 |
Terminated 3 on December 09, 2015 |
Recall Number | Z-0928-2013 |
Recall Event ID |
64344 |
PMA Number | P980049S021 P980049S024 |
Product Classification |
Defibrillator, implantable, dual-chamber - Product Code MRM
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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 CO 80004
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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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = MRM
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