Boston Scientific recalled 28,911 pacemakers worldwide due to a software flaw in Safety Architecture that could prevent Safety Mode when battery impedance is high. The recall covers ACCOLADE family devices and VISIONIST and VALITUDE CRT-Ps. Patients should stop using the device immediately and follow the recall letter 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 with CRT-P capability regulate heart rhythm for patients with heart failure or arrhythmias. They are implanted devices that provide ongoing therapy.
A software flaw could prevent initiation of Safety Mode in an ambulatory setting when battery impedance is high, potentially compromising device safety responses.
This recall is not part of a broader industry pattern.
Recipients must follow recall instructions. Immediate action may affect ongoing therapy and follow-up routines.
FDA enforcement page; Boston Scientific recall notice
Remedy timing varies; follow recall letter and clinician guidance
Retain recall notice, clinician instructions, and all correspondence; maintain a log of calls and dates
Brand: Boston Scientific. Recall affects ACCOLADE family pacemakers and VISIONIST VALITUDE CRT-P devices. Model numbers include U128 and the following: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363. GTIN: 00802526559402. Distribution: Worldwide. Recall date: 2025-08-20. Quantity: 28,911 units. Sold from unknown date; units distributed worldwide.
No injuries or incidents have been reported.
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