Boston Scientific recalled 10,833 units of its L121 ESSENTIO DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that could prevent the device from operating correctly in certain conditions. Patients and healthcare providers must stop using the device 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
The recalled model is the L121 ESSENTIO DR EL Pacemaker, part of the ACCOLADE family. Units were distributed worldwide, and the recall affects serial numbers including 100009 to 100328.
The recall addresses a software issue that may prevent the pacemaker from initiating Safety Mode in ambulatory settings due to high battery impedance. This malfunction could lead to critical health risks for patients.
No specific incidents, injuries, or deaths are reported at this time. The risk level is classified as high due to potential functional failures.
Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions from Boston Scientific and contact their healthcare provider for further guidance.
For more information, contact Boston Scientific Corporation directly or visit their official website. Additional details are available at the FDA recall report.
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