Boston Scientific recalled 63,851 L231 pacemakers worldwide on August 20, 2025. The recall covers the ACCOLADE family and related devices, including PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, and VISIONIST and VALITUDE CRT-Ps. The software flaw could prevent Safety Mode from initiating when needed. Stop using the device and contact your healthcare provider for instructions 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
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Pacemakers are implanted cardiac devices that regulate heart rhythm. The L231 model and ACCOLADE family serve dual-chamber pacing needs and, in some configurations, CRT-P therapy.
Software intended to enhance safety features may fail to trigger Safety Mode during high battery impedance events, potentially compromising device safety.
This recall is not described as part of a broader industry pattern in the provided data.
For patients, this recall means stopping use and seeking clinical guidance promptly. The impact hinges on device dependence and clinical status.
Recall notices from Boston Scientific and FDA enforcement communications list model numbers, GTINs, and corrective actions.
Remedies and replacement steps will be provided by the manufacturer through clinical channels; timelines vary by patient and device status.
Record device model, GTINs, recall date, clinician instructions, and all correspondence with the manufacturer.
Model numbers: L231. Device families affected: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL; CRT-Ps VISIONIST and VALITUDE. Sold worldwide; recall date: August 20, 2025. GTINs: 00802526559143, 00802526576423, 00802526578052. Quantity: 63,851 units. Price: Unknown.
No injuries or incidents have been reported.
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