Defibrillation lead recalled due to calcification and device failure
Boston Scientific recalls ENDOTAK RELIANCE defibrillation leads that may calcify over time, potentially requiring early replacement and posing cardiac risk.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall of a cardiac defibrillation device. FDA Class I recalls qualify for Critical severity. The potential harm—death or need for cardiac resuscitation—further justifies the highest severity level.
Plain-English summary
Boston Scientific is recalling the ENDOTAK RELIANCE G/SG with 4-SITE Connector, a transvenous defibrillation lead used in permanent defibrillator systems. The affected models are 0282, 0283, 0285, 0286, 0292, 0293, 0295, and 0296.
The defibrillation lead coils may experience calcification, which can lead to rising LVSI measurements. This condition may necessitate early lead replacement.
The most serious harm associated with this issue is death or the need for cardiac resuscitation. Approximately 247,702 units were distributed in the United States, with an additional 344,670 units distributed internationally.
The recalled product
- Product
- ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
- Manufacturer
- Boston Scientific Corporation
- Hazard
- calcification
- device-failure
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 (4)
- Model 0282 UDI-DI/GTIN 00802526431371
- Model 0283 UDI-DI/GTIN 00802526431388 00802526504181
- Model 0285 UDI-DI/GTIN 00802526431401
- Model 0286 UDI-DI/GTIN 00802526431418
Distribution
Distributed nationwide across the United States.
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