Boston Scientific recalled 3,146 units of the L209 PROPONENT DR (VDD) SL Pacemaker on August 20, 2025. The recall addresses a software issue that may cause device malfunction in ambulatory settings. Patients should stop using the device and follow manufacturer instructions immediately.
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 recalled model is the L209 PROPONENT DR (VDD) SL Pacemaker. It affects the ACCOLADE family of devices, including ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE pacemakers. The devices were distributed worldwide.
The recall is due to a software flaw that may prevent the device from entering Safety Mode in case of high battery impedance. This can pose a significant risk to patients who rely on this pacemaker for cardiac support.
No specific incidents or injuries have been reported in connection with this recall. However, the software issue presents a high risk of device malfunction.
Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, patients can contact Boston Scientific Corporation. Visit their website or call their customer service for guidance.
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