Boston Scientific recalled 190,088 ESSENTIO DR EL MRI Pacemakers on August 20, 2025. A software issue may prevent proper device operation in ambulatory settings. Patients must 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 device is the ESSENTIO DR EL MRI Pacemaker, model number L131. It affects serial numbers ranging from 102068 to 102124. The pacemaker was distributed worldwide.
The pacemaker may enter Safety Mode due to high battery impedance, potentially affecting its operation. This poses a serious risk to patients relying on the device.
There are no reported incidents or injuries associated with this recall at this time. However, the hazard classification is deemed high.
Patients should stop using the pacemaker immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions and guidance.
For more information, call Boston Scientific Corporation at 1-800-XXX-XXXX or visit their website. Additional details are available on the FDA recall page.
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