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Boston Scientific Corporation recalls ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 016
Recalled August 27, 2025 · FDA recall Z-2325-2025 · Boston Scientific
Hazard
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation. · FDA Class I
Units
247,702 US; 344,670 OUS
Sold at
Worldwide Distribution. US nationwide. International distribution worldwide.
Description
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Product
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →