Boston Scientific recalled 12,326 ACCOLADE, Visionist and Valitude pacemakers worldwide after a software issue was identified. The software enhances Safety Architecture and may prevent initiation of Safety Mode when battery impedance is high. Patients should contact their healthcare provider immediately and follow the manufacturer’s recall 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 are implanted devices that regulate heart rhythm in patients with conduction abnormalities. They are critical for maintaining steady heart rates in many patients.
The software intended to heighten Safety Architecture may fail to initiate Safety Mode when a high battery impedance state is present, potentially compromising device safety during ambulatory use.
This recall is not described as part of a broader industry pattern.
The recall targets devices used for life-sustaining rhythm management. Patients could require medical evaluation and potential device replacement or software updates under clinician supervision.
Identify numbers on the device label, patient records, and the recall notice provided by the manufacturer.
Replacement or software update timelines vary; expect several weeks to months depending on clinical scheduling.
Keep the recall letter, device label, serial numbers, and all communications with clinicians and the manufacturer for records.
Device families affected include ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual-chamber pacemakers (standard life SL and extended life EL) as well as VISIONIST and VALITUDE CRT-P devices. Model Number U225 VISIONIST CRT-P EL. GTIN 00802526559426. Serial numbers include 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912. Quantity: 12,326 units. Distribution: Worldwide. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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