Boston Scientific recalled 61,700 ESSENTIO SR SL MRI Pacemakers on August 20, 2025, due to a software issue. The software failure can lead to the device entering Safety Mode unexpectedly in high battery impedance situations. Patients must stop using the device immediately and follow recall instructions from their healthcare provider.
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 product is the ESSENTIO SR SL MRI Pacemaker, model number L110. It was distributed worldwide and includes multiple models from the ACCOLADE family. The recall affects 61,700 units.
The device's software may fail to prevent the initiation of Safety Mode during high battery impedance in ambulatory settings. This software issue presents a high hazard level and could lead to serious health risks for patients.
As of now, there are no specific reported incidents or injuries associated with this recall. The potential for failure could pose serious risks if not addressed.
Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for detailed instructions on the recall.
For further assistance, contact Boston Scientific Corporation at 1-800-XXX-XXXX or visit their website. For more information, see the FDA recall notice at the provided URL.
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