Boston Scientific recalled 4,841 pacemakers worldwide on 2025-08-20 after a software issue could prevent Safety Mode activation in ambulatory settings. The affected devices include ACCOLADE family pacemakers and VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately and follow the recall instructions in the notification letter.
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 are implanted devices that regulate heart rhythm. They are used in patients with bradycardia or heart rhythm disorders. The recall affects multiple Boston Scientific models intended for long-term rhythm management.
The defect relates to software that enhances Safety Architecture. It could prevent initiating Safety Mode in an ambulatory setting when battery impedance is high, potentially compromising device safety features.
This recall is not described as part of a broader industry pattern.
Affected patients may require medical evaluation, device monitoring, or replacement. The recall could disrupt ongoing rhythm-management therapy and necessitate clinical scheduling.
Identifiers are on device labeling and packaging. Serial numbers are usually recorded in the patient device record and recall communications.
Remedies and replacements may take weeks to months, depending on clinical needs and device availability.
Keep the recall notification, device identifiers, clinician communications, and any replacement or monitoring documentation.
Product: Pacemaker; Brand: Boston Scientific; Model numbers/identifiers: S701 ALTRUA 2 SR SL Pacemaker; GTINs 00802526576492 and 00802526559334; Serial numbers 705372, 100002, 100003-100021; Distribution: Worldwide; Sold: Unknown; Price: Unknown; Quantity recalled: 4841 units.
No injuries or incidents have been reported.
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