Boston Scientific recalled 7,488 ACCOLADE DR EL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode. Patients should stop using the device immediately and follow recall 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
The recalled models include ACCOLADE DR EL (Model L321) and other devices such as PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE. These pacemakers were distributed worldwide.
The software issue may prevent initiation of Safety Mode in an ambulatory setting due to high battery impedance. This can lead to potential health risks for patients relying on these devices.
No specific injuries or incidents have been reported in relation to this recall. The classification of this recall is Class I, indicating a high hazard level.
Patients and healthcare providers must stop using the device immediately. Contact Boston Scientific Corporation or a healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0083-2026 or contact Boston Scientific Corporation.
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