Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models

FDA device recall Z-0087-2015 · posted 2014-10-18 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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

Action taken

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 tech.services@bsci.com.

Root cause

Component design/selection

Status

Terminated

Product code

LWP

Quantity affected

31,144 total

Distribution

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, Belgiu

Date initiated

2014-09-17

Date posted

2014-10-18

Date terminated

2015-02-20

Location

Saint Paul, MN