Boston Scientific recalled 7,488 pacemakers worldwide due to software that could impair Safety Mode initiation in high-battery-impedance states. Devices include ACCOLADE family models and CRT-Ps such as VISIONIST and VALITUDE. The issue stems from software designed to enhance Safety Architecture. Patients should follow manufacturer instructions and contact providers 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 and CRT-Ps are implanted devices that regulate heart rhythm. They are critical for patients with certain heart conditions.
Software intended to enhance Safety Architecture may hinder proper initiation of Safety Mode in certain battery impedance states, potentially compromising device safety.
This recall is not part of a broader industry pattern.
This recall directly affects patients reliant on life-sustaining devices and requires prompt medical guidance and remediation.
Serial numbers and GTINs can be found on device labels and in patient records; reference recall notice for exact numbers.
Remedy process coordinated via healthcare providers; timing varies by patient and program.
Keep all recall notices, serial numbers, GTINs, and correspondence with providers and manufacturer.
Brand: Boston Scientific. Products: ACCOLADE family pacemakers (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and DR EL), VISIONIST CRT-P, VALITUDE CRT-P. Quantity: 7,488 units. Distribution: Worldwide. Recall date: 2025-08-20. Status: Active. Notification method: Letter.
No specific injuries or incidents are described in the provided data.
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