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

FDA device recall Z-0609-2010 · posted 2010-01-13 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

BSC CRM provided important patient management information regarding Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs. Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. A weakened header bond may alter lead impedance and introduce noise

Action taken

Boston Scientific CRM issued an "Urgent Medical Device Correction" letter dated December 01, 2009. The letter described the issue and potential device behavior. The letter provided recommendations to avoid issues relating to the affected device until improved devices become available. For further information, contact your local Boston Scientific CRM representative, United States Technical Services at 1-800-227-3422, or European Technical Services at +32-2-416-7222.

Root cause

Device Design

Status

Terminated

Product code

LWP

Quantity affected

39,873

Distribution

Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canad

Date initiated

2009-12-01

Date posted

2010-01-13

Date terminated

2012-11-06

Location

Saint Paul, MN