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U.S. Department of Health and Human Services

Class 1 Device Recall Ventak PRIZM 2 DR ICD

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  Class 1 Device Recall Ventak PRIZM 2 DR ICD see related information
Date Initiated by Firm June 17, 2005
Date Posted June 30, 2005
Recall Status1 Terminated 3 on January 05, 2007
Recall Number Z-0906-05
Recall Event ID 32379
PMA Number P960040S015 
Product Classification Programmer, Pacemaker - Product Code KRG
Product Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy.
Code Information Serial number range 118626 - 243772 includes ICDs manufactured prior to November 13, 2002. This range includes all affected devices but may include some unaffected devices.
Recalling Firm/
Manufacturer		 Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
Manufacturer Reason
for Recall		 Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical short. The short caused diversion of shock therapy energy away from the heart and into device circuitry.
FDA Determined
Cause 2		 Other
Action Dear Doctor letter, dated 05/23/05, was sent to doctors 05/23/05 making them aware of 26 random component failures including one death. Doctors were advised to continue normal monitoring of all patients as indicated in device labeling. Press Release was also issued 05/25/05. Another Dear Doctor letter was dated and issued on 06/17/05. This letter provided updated information to the 05/23/05 letter. The letter gave some indications of device failure and recommendations for normal patient monitoring on routine follow-up visits. Another press release was also issued on 06/17/05.
Quantity in Commerce 38,362 (Approx. 24,000 are currently implanted worldwide)
Distribution Worldwide. Including United States and countries such as: Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Polynesia, Portugal, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Uruguay, 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.
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