Boston Scientific recalled 223,163 ESSENTIO DR SL MRI pacemakers on August 20, 2025. The recall addresses a software issue that could prevent the device from functioning properly in certain conditions. Users should stop using the device 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
The recalled model number is L111, part of the ACCOLADE family of devices. It includes ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual chamber pacemakers, and VISIONIST and VALITUDE CRT-Ps. These devices were distributed globally.
The software issue may prevent the initiation of Safety Mode in an ambulatory setting due to high battery impedance. This situation poses a significant risk to patients relying on these devices.
No specific incidents or injuries have been reported in connection with this recall. The recall is classified as Class I, indicating a high risk.
Patients and healthcare providers should stop using the ESSENTIO DR SL MRI pacemaker immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, visit the Boston Scientific website or call the customer service line. Additional details are available at the FDA’s recall notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0095-2026.
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