CONTAK RENEWAL 2 (model H155) Heart Failure Device. 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.
This recall has been terminated (originally issued June 30, 2005).
- Company
- Guidant Corporation
- Recall Initiated
- June 17, 2005
- Posted
- June 30, 2005
- Terminated
- January 10, 2007
- Recall Number
- Z-0908-05
- Quantity
- 16,000 (Approximately 11,900 remain implanted worldwide) - both products combined
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
RENEWAL 2 (model H155) serial number range 173277 - 777182 includes CRT-Ds manufactured on or before August 26, 2004.
Root Cause
Other
Action Taken
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.