Boston Scientific Corporation: RELIANCE 4-FRONT, endocardial
Recall reason: 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.. Recalled by Boston Scientific Corporation. Distribution: Worldwide Distribution. US nationwide. International distribution worldwide.. Classification (Class I — serious health hazard). Affected lots/dates: Model 0657 UDI-DI 00802526560934; Model 0682 UDI-DI 00802526560958; Model 0683 UDI-DI 00802526560965; Model 0685 UDI-. Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, r
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