Boston Scientific recalled 1,050 cardiac pacemakers on August 20, 2025. The recall affects the VISIONIST and ACCOLADE families of devices due to a software issue. Patients must stop using the devices immediately to prevent potential safety risks.
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
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The recall involves model number U226, VISIONIST CRT-P EL and other models in the ACCOLADE family. The devices were distributed worldwide and affected serial numbers include 700333, 700335, and others.
The recall addresses a software issue that may prevent the proper initiation of Safety Mode in an ambulatory setting. This concern arises from a high battery impedance state, posing a significant risk to patients.
No specific incidents or injuries related to this recall have been reported. However, the device's failure to enter Safety Mode is a serious concern.
Patients and healthcare providers must stop using the recalled devices immediately. They should contact Boston Scientific Corporation or their healthcare provider for detailed instructions.
For more information, call Boston Scientific Corporation or refer to their website. Additional details can be found at the FDA recall notice.
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