Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion
Boston Scientific is recalling COGNIS CRT-Ds and TELIGENT ICDs due to a capacitor defect that may cause the battery to deplete prematurely.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a functional defect (premature battery depletion) poses a risk of harm to patients, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific CRM Corp is recalling a subset of COGNIS Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGENT Implantable Cardioverter Defibrillators (ICDs). The recall involves 31,144 total units distributed worldwide, including nationwide in the United States and its territories.
The recall is due to compromised performance of a low voltage (LV) capacitor, which has resulted in an increased rate of premature battery depletion. Boston Scientific updated its August 2013 physician communication to include additional devices that may be affected by this issue.
Patients with these implanted devices should contact their healthcare provider or Boston Scientific to determine if their specific device is affected and to discuss appropriate management options.
The recalled product
- 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. Product Usage: Boston Scientific cardiac resynchronization
- Manufacturer
- Boston Scientific CRM Corp
- Affected units
- 31,144
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model N106 - Serial numbers: 222276
- 222277
- 222279
- 222280
- 222282
- 222283
- 222286
- 222289
- 222290
- 222291
- 222292
- 222293
- 222295
- 222311
- 222312
- 222314
- 222315
- 222316
- 222318
- 222320
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific CRM Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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