Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107.
FDA Recall Z-1678-2009 · Posted 2009-07-14
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Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWP
Date Initiated2009-03-23
Date Terminated2012-10-18
Product Quantity49,148 total
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.
Firm Action
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
Distribution Pattern
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, Hungary, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Netherlands, New Caledonia, Norway, Philippines, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, and Venezuela.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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