Boston Scientific Corporation: RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685,

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Distribution. US nationwide. International distribution worldwide. Quantity: 247,702 US; 344,670 OUS Lot/code info: Model 0657 UDI-DI 00802526560934; Model 0682 UDI-DI 00802526560958; Model 0683 UDI-DI 00802526560965; Model 0685 UDI-DI 00802526560972; Model 0686 UDI-DI 00802526560989; Model 0692 UDI-DI 00802526519017 00802526560996 00802526568664 00802526568688; Model 0693 UDI-DI 00802526518850 00802526519055 00802526537769 00802526561009 00802526568701; Model 0695 UDI-DI 00802526519093 00802526561016; Model 0696 UDI-DI 00802526519987 00802526561207 00802526568831

UPC codes

00802526560934, 00802526560958, 00802526560965, 00802526560972, 00802526560989, 00802526519017, 00802526560996, 00802526568664, 00802526568688, 00802526518850, 00802526519055, 00802526537769, 00802526561009, 00802526568701, 00802526519093, 00802526561016, 00802526519987, 00802526561207, 00802526568831

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.