Boston Scientific recalled 3,146 pacemakers worldwide after identifying a software defect that could prevent Safety Mode initiation in an ambulatory setting. Devices include ACCOLADE family models and VISIONIST and VALITUDE CRT-Ps. Patients should stop using affected devices and follow manufacturer 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. The affected line includes ACCOLADE family and related CRT-P devices.
Software intended to reinforce Safety Mode may fail to initiate when a high battery impedance state is encountered, potentially impacting patient safety.
This recall is not described as part of a broader industry pattern in the provided data.
Immediate action is required by patients and clinicians to prevent potential unsafe device operation and ensure proper management.
Refer to the recall letter and FDA enforcement report for serial numbers and affected models
Recall processing and potential replacement or software update timelines will vary by device and clinical setting
Keep recall notification, device serial numbers, hospital correspondence, and insurer communications
Model Number L209 PROPONENT DR (VDD) SL Pacemaker. Devices in ACCOLADE family including ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual chamber SL and EL, and VISIONIST and VALITUDE CRT-Ps. Quantity: 3,146 units. Distribution: Worldwide.
No specific injuries or incidents are described in the provided documentation.
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