Boston Scientific recalled 1,380 PROPONENT SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent safety mode activation in ambulatory settings. Healthcare providers and patients must stop using the devices 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 recall affects the PROPONENT SR SL model (GTIN 00802526559020) along with several serial numbers. These devices were distributed worldwide.
A software issue may prevent the initiation of safety mode due to high battery impedance. This failure poses a high risk to patient safety.
No specific incidents, injuries, or deaths have been reported related to this recall. However, the potential for severe consequences warrants immediate action.
Patients should stop using the recalled pacemakers immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For assistance, call Boston Scientific at their customer service line or visit their website for updates on the recall.
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