Devices

Device Recall CONTAK RENEWAL 2 CRTDefibrillator

Model / Serial
RENEWAL 2 (model H155) serial number range 173277 - 777182 includes CRT-Ds manufactured on or before August 26, 2004.
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 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.
Manufacturer
Guidant Corporation
1 Event
- Recall of Device Recall CONTAK RENEWAL 2 CRTDefibrillator

Manufacturer

Guidant Corporation

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

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