Devices

Device Recall CONTAK RENEWAL RF and CONTAK RENEWAL RF HE

Model / Serial
all serial numbers
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
Product Description
CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac Resynchronization Therapy Defibrillator. Sterile EO. Guidant Corporation, 4100 Hamiline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 RF devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
Manufacturer
Guidant Corporation
1 Event
- Recall of Device Recall CONTAK RENEWAL RF and CONTAK RENEWAL RF HE

Manufacturer

Guidant Corporation

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

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