Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models
FDA device recall Z-1678-2009 · posted 2009-07-14 · Terminated
Recall details
- Recalling firm
- Boston Scientific CRM Corp
- Reason for recall
- Lead connection issues or fracture increases probability of inappropriate therapy: Inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.
- Action taken
- Boston Scientific sent an Urgent Medical Device Information letter, dated March 23, 2009, to physicians following implanted devices. The letter described the issue, the rate of occurance and provided Patient Management Recommendations.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LWP
- Quantity affected
- 49,148 total
- Distribution
- Worldwide distribution: USA, Guam, Puerto Rico, Aruba, Austria, Belgium, Brazil, Canada, Cayman Islands, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong,
- Date initiated
- 2009-03-23
- Date posted
- 2009-07-14
- Date terminated
- 2012-10-18
- Location
- Saint Paul, MN
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