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U.S. Department of Health and Human Services

Class 1 Device Recall CONTAK RENEWAL AVT CRTD

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  Class 1 Device Recall CONTAK RENEWAL AVT CRTD see related information
Date Initiated by Firm July 25, 2005
Date Posted August 16, 2005
Recall Status1 Terminated 3 on April 07, 2008
Recall Number Z-1109-05
Recall Event ID 32738
Product Classification Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
Product CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M157 and M159; CONTAK RENEWAL 4 AVT, model numbers M170 and M175; CONTAK 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, St. Paul, MN 55112-5798, USA. CONTAK RENEWAL 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 Guidant Rep or Technical Services
800-227-3422
Manufacturer Reason
for Recall		 Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.
FDA Determined
Cause 2		 Other
Action Urgent Medical Device Safety Information & Corrective Action letter dated 07/22/05 was either mailed or Federal Expressed to doctors. This letter informed doctors that Guidant was revising its original recommendations set forth in the June 17, 2005 letter because new information indicates that one of the original recommendations can increase the risk of a latching event. Contained in this letter were Clinical Implications and Revised Recommendations.
Quantity in Commerce 2,204 devices (approximately 760 currently implanted worldwide)
Distribution Worldwide. In addition to the US other countries 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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