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U.S. Department of Health and Human Services

Class 2 Device Recall CONTACT RENEWAL AVT CRTD

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  Class 2 Device Recall CONTACT RENEWAL AVT CRTD see related information
Date Initiated by Firm June 17, 2005
Date Posted June 30, 2005
Recall Status1 Terminated 3 on March 02, 2008
Recall Number Z-0956-05
Recall Event ID 32391
Product Classification Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
Product CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model numbers M157 and M159; CONTACT RENEWAL 4 AVT model numbers M170 and M175; CONTACT RENEWAL 4 AVT HE model numbers M177 and 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.
Code Information all serial numbers
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
866-484-3268
Manufacturer Reason
for Recall		 The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
FDA Determined
Cause 2		 Other
Action Firm issued a Dr. Doctor letter dated 06/17/05. Letter informs physicians of the issue, clinical implications, recommendations and action taken by the firm.
Quantity in Commerce 2,204 devices (786 remain implanted worldwide)
Distribution worldwide. To the US and OUS countries to include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.
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.
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