Recall Z-0025-2014— Boston Scientific CRM Corp
Class II · Terminated
Class II FDA medical device recall by Boston Scientific CRM Corp, initiated 2013-08-29, terminated 2014-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.. Reason: 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..
- Recalling firm
- Boston Scientific CRM Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-29
- Terminated
- 2014-04-10
- Firm location
- Saint Paul, MN, United States
Product description
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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.