Boston Scientific recalled 41,191 pacemakers on August 20, 2025, due to a software issue that may prevent proper safety functions. The recall affects several models in the ACCOLADE and VISIONIST families of devices. Patients should stop using the devices immediately and follow manufacturer instructions.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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The recall includes model number U228, VISIONIST CRT-P EL MRI pacemakers. The affected devices were distributed worldwide and are part of the ACCOLADE family of devices.
The software issue may fail to prevent the initiation of Safety Mode in an ambulatory setting caused by high battery impedance. This poses a significant health risk to patients relying on the devices.
There have been no reported injuries or deaths associated with this recall. Nonetheless, the potential for serious health complications exists.
Patients and healthcare providers must stop using the recalled devices immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, call Boston Scientific Corporation or visit their website. Patients can also refer to the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0105-2026.
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