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U.S. Department of Health and Human Services

Class 1 Device Recall CONTAK RENEWAL CRTDefibrillator

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  Class 1 Device Recall CONTAK RENEWAL CRTDefibrillator see related information
Date Initiated by Firm June 17, 2005
Date Posted June 30, 2005
Recall Status1 Terminated 3 on January 10, 2007
Recall Number Z-0907-05
Recall Event ID 32380
PMA Number P010012S002 
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
Product CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798. USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
Code Information RENEWAL (model H135) serial number range 100027 - 999983 includes CRT-Ds manufactured on or before August 26, 2004. These ranges include all affected devices but may include some unaffected devices.
Recalling Firm/
Manufacturer		 Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
866-484-3268
Manufacturer Reason
for Recall		 Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.
FDA Determined
Cause 2		 Other
Action Dear Doctor letter was dated and issued 06/17/05 informing Doctors of an shorting issue of the Renewal 1 & 2 CRT-D devices. The letter gave indications of device failure and recommendations for patient visits. A press release was also issued on 06/17/05.
Quantity in Commerce 16,000 (Approximately 11,900 remain implanted worldwide)
Distribution worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom and Venezuela.
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.
PMA Database PMAs with Product Code = NIK and Original Applicant = Boston Scientific Corp.
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