ClearanceBrief
Recall Z-0087-2015 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)

Boston Scientific CRM Corp

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. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic desp

DateOct 18, 2014 (initiated Sep 17, 2014)
StatusTerminated
ReasonBoston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt
Root causeComponent design/selection
ActionBoston Scientific sent an Important Medical Device Information letter to physicians beginning September 17, 2014. The letter provided a summary of the issue, described clinical implications and expected device performance, and provided patient monitoring recommendations. Boston Scientific is introducing upgraded program software (Model 2868, version 3.04) that enhances the effectiveness of the Safety Architecture tools. Questions should be addressed to Boston Scientific Representative or Technical Services 1-800-227-3422 or tech.services@bsci.com.
Quantity31,144 total
DistributionWorldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.