Boston Scientific recalled 34,180 ACCOLADE DR EL MRI pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper function in ambulatory settings. Patients should stop using the devices immediately and contact 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 recall involves ACCOLADE DR EL MRI pacemakers, model L331. The devices were distributed worldwide and have been linked to serious safety concerns.
The software issue may prevent the pacemakers from entering Safety Mode due to high battery impedance. This could lead to inadequate cardiac support, posing a high risk to patients.
As of now, there are no specific reported incidents or injuries directly linked to this software malfunction. However, the potential for serious health risks remains.
Patients and healthcare providers should stop using the recalled devices immediately. Contact Boston Scientific or a healthcare provider for further instructions.
Patients can reach Boston Scientific at their official website for more information regarding the recall.
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