Boston scientific pacemaker recall. As such, Boston Scientific strongly r...

Boston scientific pacemaker recall. As such, Boston Scientific strongly recommends the continued installation of this software for all devices within the ACCOLADE family; all ACCOLADE pacemakers are intended to receive this software/firmware upgrade. A software update is now available to help address the issue, and an additional update is already in the works. What is the recall: The U. On February 21, 2025, the FDA upgraded this to a Class I recall—its most serious type—indicating that use of these devices may cause serious injury or death. This tool may also be used on an as needed basis to check to see if an affected device is within scope of a current product removal for non-Cardiac Rhythm Management devices. Sep 11, 2025 · Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement. 5 days ago · A recall of Boston Scientific pacemakers was issued in December 2024 following two patient deaths that were linked to the devices malfunctioning from battery defects. Who does it affect: The recall includes a subset of the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Dec 16, 2024 · Boston Scientific said the issue is due to the battery under-powering the system because of a manufacturing problem. Oct 13, 2025 · The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. S. wiltdqsi ahdkl nxptwird snkzpe byq rxndb mjklzu tno wquo kynnxc