Boston Scientific recalled 190,088 pacemakers worldwide, including ACCOLADE family devices and related CRT-Ps. The software to enhance Safety Architecture could prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. Patients and healthcare providers should stop using these devices immediately and await manufacturer instructions by 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 regulate heart rhythm in patients with arrhythmias and are implanted devices monitored by clinicians.
A software update intended to enhance Safety Architecture could prevent activation of Safety Mode when battery impedance is high, potentially compromising safety.
This recall is not part of a broader industry pattern.
Patients may require clinician-directed actions, including monitoring or device replacement, with significant medical implications if unsettled.
Serial numbers appear on the device, its packaging, and patient card; GTIN appears on packaging
Not specified by the manufacturer
Keep all recall letters, device serial numbers, packaging photos, and communication records with providers and the company
Model Number: L131, ESSENTIO DR EL MRI Pacemaker. Quantity: 190,088 units. Distribution: Worldwide. GTIN: 00802526559266. Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124. Includes ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual chamber SL and EL DR devices, and VISIONIST and VALITUDE CRT-Ps.
No injuries or incidents have been reported.
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