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Devices
Device Recall CONTAK RENEWAL 3 & 4 AVT
Model / Serial
Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Guidant.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide, US Virgin Islands, Puerto Rico and worldwide to include: Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Polynesia, Portugal, Qatar, Russia, Saint Lucia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, West Indies.
Product Description
Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL 4 AVT (models M170, M175), CONTAK RENEWAL 4 AVT HE (models M177, M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
Manufacturer
Guidant Corporation
1 Event
Recall of Device Recall CONTAK RENEWAL 3 & 4 AVT
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Manufacturer
Guidant Corporation
Manufacturer Address
Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
Source
USFDA
Language
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