Boston Scientific recalled 34,180 devices worldwide on 2025-08-20 for ACCOLADE family pacemakers and CRT-Ps due to software that could prevent Safety Mode in high battery impedance conditions. The defect affects ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and EL models, plus VISIONIST and VALITUDE CRT-P devices. Patients should stop using the devices 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
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Pacemakers and CRT-Ps regulate heart rhythms for patients with heart conditions. They are implanted devices requiring ongoing monitoring and follow-up.
A software flaw could prevent Safe Mode activation in high impedance battery states, reducing protective safety features.
This recall is not part of a broader industry pattern.
Immediate action is required by patients and providers to align with official guidance and protect patient safety.
Manufacturer recall notice, patient letter, and FDA enforcement report linked in recall page.
Remedies and next steps are determined by the manufacturer; patients should expect guidance from healthcare providers.
Keep copy of recall notice, serial numbers, physician notes, and any correspondence with provider.
Brand: Boston Scientific. Product: ACCOLADE family pacemakers and VISIONIST/VALITUDE CRT-P devices. Model: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and DR EL, VISIONIST, VALITUDE. GTIN/Serials: GTIN 00802526559006; Serial Numbers include: 102138, 102172, 102192, 102209, 102210, 102229, 102231, 102232, 102233, 102237, 102239, 102243, 102255, 102256, 102261, 102263, 102265, 102266, 102267. Quantity: 34,180 units. Distribution: Worldwide. Recall date: 2025-08-20. Status: Active.
No specific injury or incident counts are provided in the recall notice. The hazard level is classified as HIGH.
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