Boston Scientific recalled 16,077 ACCOLADE SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode in high battery impedance states. Patients must stop using the device immediately and follow manufacturer's 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
The recall involves ACCOLADE SR SL pacemakers, model L300. These devices were distributed worldwide.
The software issue may prevent the initiation of Safety Mode during high battery impedance states. This situation poses a serious risk as it can affect the device's functionality in ambulatory settings.
No specific incidents have been reported, but the potential for serious complications exists due to the software failure.
Patients and healthcare providers should stop using the device immediately. They must contact Boston Scientific Corporation or their healthcare provider for further instructions.
For more information, visit the Boston Scientific website or call their customer service. Recall instructions are also available in the notification letters sent to users.
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