Boston Scientific recalled 1,050 pacemaker units worldwide on Aug 20, 2025. The recall covers ACCOLADE family devices and Visionist and Valitude CRT-Ps. A software issue could prevent Safety Mode initiation in ambulatory settings. Patients should follow manufacturer guidance and contact their clinician 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 implanted to regulate heart rhythm. They are life-sustaining for many patients and often require regular monitoring.
Software upgrade intended to enhance Safety Architecture could prevent initiation of Safety Mode in ambulatory settings due to high battery impedance state.
This recall is not part of a broader industry pattern.
High risk to device performance; patients should follow clinician instructions and contact the manufacturer promptly.
FDA recall page Z-0104-2026 and Boston Scientific patient safety communications.
Remediation timelines set by company and regulators; stay in contact with clinicians for updates.
Keep recall notification, device serial and model numbers, clinician correspondence
Model numbers and devices affected include U226 and multiple GTIN and model codes (GTIN 00802526559457; 700333, 700335, 700342, 700344, 700346, 700347, 700352, 700364, 700372, 700386, 700388, 700390, 700391, 700425, 700426, 700427, 700428, 700429, 700437). Worldwide distribution. Quantity 1,050 units.
No specific injuries or incidents are provided in the available data. The status is listed as HIGH hazard and Class I recall.
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