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

FDA device recall Z-0025-2014 · posted 2013-10-17 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.

Action taken

An Important Medical Device Information letter dated August 2013 was sent to implanting and following physicians. The letter provided a description of the issue, describes clinical implications, provides the rate of occurrence, and gives recommendations for monitoring patients.

Root cause

Component design/selection

Status

Terminated

Product code

LWP

Quantity affected

38,500 total worldwide

Distribution

Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Ric

Date initiated

2013-08-29

Date posted

2013-10-17

Date terminated

2014-04-10

Location

Saint Paul, MN