Boston Scientific recalled 106,536 PROPONENT DR SL MRI pacemakers on August 20, 2025, due to software issues. The recall affects multiple models and aims to prevent safety mode initiation in ambulatory settings. Patients must stop using these devices immediately and follow the 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
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The recall involves the Model Number L211 PROPONENT DR SL MRI Pacemaker. It includes several models from the ACCOLADE family, specifically the ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2. These devices were distributed worldwide.
The software issue may cause a high battery impedance state, leading to the initiation of Safety Mode in an ambulatory setting. This can pose serious risks to patients relying on these pacemakers.
No specific injuries or deaths were reported in relation to this recall. However, the potential risks associated with the software issue are classified as high.
Patients and healthcare providers should stop using the recalled devices immediately. Follow the recall instructions provided by Boston Scientific. Contact your healthcare provider or Boston Scientific for further instructions.
For more information, visit the Boston Scientific website or call their customer service. Additional details can be found at the FDA recall page.
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