Boston Scientific recalled 41,009 pacemakers on August 20, 2025, due to a software issue that could trigger Safety Mode. This affects the ACCOLADE family of devices, including the PROPONENT model. Patients should stop using these devices immediately and contact their healthcare provider.
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 involves model number L210 PROPONENT SR SL pacemakers. These devices were distributed worldwide.
The recall addresses a software issue that prevents the initiation of Safety Mode in ambulatory settings due to high battery impedance states. This malfunction can lead to serious health risks for patients.
No specific incidents or injuries have been reported associated with this recall. The potential for harm exists if the device enters Safety Mode unexpectedly.
Patients and healthcare providers should 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. Detailed recall instructions are also available in a notification letter.
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