Terminated

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 despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

FDA Recall Z-0087-2015 · Posted 2014-10-18

Recalling FirmBoston Scientific CRM Corp

Recall StatusTerminated

Product CodeLWP

Date Initiated2014-09-17

Date Terminated2015-02-20

Product Quantity31,144 total

Reason for Recall

Boston 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

Firm Action

Boston 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 [email protected].

Root Cause

Component design/selection

Distribution Pattern

Worldwide 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, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.