Boston Scientific recalled 22,714 ACCOLADE family pacemakers worldwide on August 20, 2025. A software feature intended to enhance Safety Architecture may fail to initiate Safety Mode due to a high battery impedance state. Patients and healthcare providers should stop using this device immediately and await manufacturer 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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Implantable pacemakers regulate heart rhythm for patients with bradycardia or heart failure. The ACCOLADE family covers several models used in adults worldwide.
A software feature designed to enhance Safety Architecture may not initiate Safety Mode when required due to a high battery impedance state. This could affect how the device responds in dangerous scenarios.
This recall is not described as part of a broader industry pattern.
The recall affects patients with implanted devices. Stopping use is not user-manageable; clinical action is required. The recall could require device replacement or monitoring, with procedural risks and scheduling delays.
Serial numbers and model identifiers appear on the patient ID card, device box labeling, and hospital records. The recall letter from the manufacturer contains specific identifiers.
Device replacement or monitoring can take weeks to months and is arranged through your clinician. The recall notice provides steps and follow-up needs
Keep the recall letter, device ID numbers, hospital records, and all communications with the clinician or manufacturer.
Model Number L101; GTIN 00802526559174; Serial Numbers: 100547, 100752, 100822, 100843, 100852, 100853, 100857, 100863, 100865, 100866, 100868, 100871, 100874, 100879, 100883, 100884, 100889, 100891, 100892; Quantity: 22,714 units; Distribution: Worldwide; Recall Date: 2025-08-20; Remedy: Stop using the device and follow recall instructions provided by the manufacturer.
No injuries or incidents have been reported.
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