Boston Scientific recall affects 4,055 pacemakers worldwide. The recall covers ACCOLADE family devices, ALTRUA 2 DR SL/EL, VISIONIST and VALITUDE CRT-P models. Software intended to enhance Safety Architecture can fail to initiate Safety Mode in ambulatory settings. Patients should stop using the device and contact their clinician.
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 provide heart rhythm support for patients with bradycardia or conduction disorders. They are implanted devices monitored by clinicians.
Software intended to enhance Safety Architecture may fail to initiate Safety Mode in the presence of high battery impedance, potentially compromising device safety.
This recall is not part of a broader industry pattern.
Patients may experience uncertainty and require urgent medical guidance.
Recall notices and FDA enforcement report Z-0099-2026 linked to Boston Scientific devices
Official remediation timelines to be provided by Boston Scientific through patient and clinician communications
Document all communications with clinicians and the manufacturer, retain device serial numbers and recall letters
Model: S702. Devices: ACCOLADE family (ACCOLADE, PROPONENT, ESSENTIO), ALTRUA 2 DR SL and DR EL, VISIONIST CRT-P, VALITUDE CRT-P. Quantity: 4,055 units. Distribution: Worldwide. Sold by: Manufacturer through medical channels. Recall date: 2025-08-20. Notification method: Letter.
No specific injuries or incidents are detailed in the provided data. The status is ACTIVE with a HIGH hazard level.
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