Tag: pacemakers

Boston Scientific Issues Class I Recall and Software Correction for ACCOLADE Pacemakers

7 May 2026 3:54 p.m. · Source: US Food and Drug Administration

Boston Scientific has issued a Class I recall for ACCOLADE pacemakers and CRT-Ps, requiring a critical software update. The FDA warns that failing to correct the devices could lead to early replacement, serious injury, or death.

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