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U.S. Department of Health and Human Services

Class 2 Device Recall CONTAK RENEWAL 3 and CONTAK RENEWAL 3 HE

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  Class 2 Device Recall CONTAK RENEWAL 3 and CONTAK RENEWAL 3 HE see related information
Date Initiated by Firm June 24, 2005
Date Posted June 30, 2005
Recall Status1 Terminated 3 on December 31, 2006
Recall Number Z-0949-05
Recall Event ID 32496
PMA Number P010012S008 
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
Product CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5511-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
Code Information all serial numbers
Recalling Firm/
Manufacturer		 Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
866-484-3268
Manufacturer Reason
for Recall		 Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.
FDA Determined
Cause 2		 Other
Action Firm issued a Dr. Doctor letter dated 06/23/05. Letter informs physicians of the issue, clinical implications and recommendations. UPDATE: An Advisory Update, dated 08/01/05 is being issued to physicians to inform them of a new programmer software application upgrade and the programmer screen alerts. Additionally regulatory approval was given for a new switch component that will be incorporated into all Guidant CRT-D products.
Quantity in Commerce 48,157
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NIK and Original Applicant = Boston Scientific Corp.
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