Boston Scientific is recalling 41,191 ACCOLADE family pacemakers and Visionist and Valitude CRT-P devices worldwide. The software to enhance Safety Architecture could prevent Safety Mode activation in ambulatory settings when a high battery impedance state is present. Patients should stop using the device and contact their healthcare provider for 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 regulate heart rhythm and are implanted in patients to manage arrhythmias. CRT-P devices like Visionist and Valitude are used to synchronize heart chambers in certain conditions. This recall covers multiple BAC devices under the ACCOLADE family and these CRT-P models.
A software upgrade intended to improve Safety Architecture could inadvertently prevent Safety Mode from activating if a high battery impedance state occurs, potentially compromising device safety.
This recall is not described as part of a broader industry pattern in the notice.
Patients with affected devices could face safety risks if the device fails to enter required safety modes. Immediate action is advised through medical professionals to determine next steps.
Recall letters, FDA enforcement report, and manufacturer communications include identifiers, steps, and contact information.
Not specified in the recall notice. Healthcare providers will coordinate replacements or other actions.
Document recall notice, device model/serial numbers, clinician communications, and any replacement actions.
Model numbers: U228, VISIONIST CRT-P EL MRI. Devices affected include ACCOLADE family devices (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual chamber DR SL and DR EL) and VISIONIST and VALITUDE CRT-Ps. GTIN: 00802526559471. Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748. Distribution: Worldwide. Quantity: 41,191 units. Sold at: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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