Devices

Device Recall CONTAK RENEWAL CRTDefibrillator

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
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.
Product Description
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.
Manufacturer
Guidant Corporation
1 Event
- Recall of Device Recall CONTAK RENEWAL CRTDefibrillator

Manufacturer

Guidant Corporation

Manufacturer Address
Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
Source
USFDA

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