Boston Scientific recalled 63,851 Proponent DR EL MRI Pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper device function in certain conditions. Patients must 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 Proponent DR EL MRI Pacemaker has model number L231. It was distributed worldwide and belongs to the ACCOLADE family, including ACCOLADE, ESSENTIO, and ALTRUA 2 pacemakers.
The software issue can lead to the initiation of Safety Mode in an ambulatory setting due to high battery impedance. This situation poses a significant risk to patients depending on the device for heart regulation.
No specific injuries or deaths have been reported as of now. The hazard classification is rated as Class I, indicating a high risk of serious health consequences.
Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
Patients can reach Boston Scientific at their official website or through the recall notification letter for further guidance.
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