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U.S. Department of Health and Human Services

Class 2 Device Recall ENDOTAK RELIANCE SG

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  Class 2 Device Recall ENDOTAK RELIANCE SG see related information
Date Initiated by Firm June 19, 2014
Date Posted August 05, 2014
Recall Status1 Terminated 3 on December 03, 2014
Recall Number Z-2147-2014
Recall Event ID 68700
PMA Number P919973S115 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO.

Product Usage:
The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.
Code Information Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339. 
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact Local Sales Representative
800-227-3422
Manufacturer Reason
for Recall		 A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Sales representatives hand delivered a Boston Scientific "Medical Device Retrieval" Letter dated June 19, 2014 or June 20, 2014 when they were retrieving the devices from the hospital shelves. The letter was addressed to Hospital Administrator. The letter described the problem, product being recalled and the retrieval of the device by Boston scientific sales representative. For further questions they can contact their local sales representative or Boston Scientific International Technical Services. Physicians were contacted via telephone starting on July 6, 2014. A Boston Scientific letter dated July 8, 2014 followed the telephone conversation. For further information physicians can contact their local Boston Scientific representative or Technical Services at 1-800-227-3422.
Quantity in Commerce 21
Distribution Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
Total Product Life Cycle TPLC Device Report
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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