Boston Scientific recalled 61,700 pacemakers worldwide after a software issue was identified. The device safety architecture could fail to initiate Safety Mode when battery impedance is high. Healthcare providers were advised to stop using the affected devices and follow recall instructions from the manufacturer.
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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These pacemakers are implanted devices that regulate heart rhythm and may be used with MRI procedures in some configurations. They are distributed worldwide to healthcare providers.
A software feature intended to enhance Safety Architecture could fail to initiate Safety Mode when battery impedance is high, potentially compromising the device’s safety response.
This recall is not described as part of a broader industry pattern in the provided information.
The issue concerns patients reliant on these devices. The recall requires immediate cessation of use and coordination with clinicians to determine next steps.
Recall notices from Boston Scientific and the FDA enforcement page include model numbers and serial numbers.
Recall processing timelines are provided in the manufacturer letter; no specific timeframe is listed here.
Keep the recall letter, device identifiers (model, serial, GTIN), clinician notes, and any correspondence with the manufacturer.
Brand: Boston Scientific Product family: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL; VISIONIST CRT-P; VALITUDE CRT-P Model numbers: GTIN 00802526559204; Serial Numbers: 102163; 700197; 700207; 701035; 701546; 702086; 702129; 702195; 702303; 702316; 702343; 702530; 702612; 702615; 702619; 702715; 702745; 702802; 702807 Distribution: Worldwide Quantity: 61700 Sold at: Unknown Price: Unknown Date sold: Unknown
No injuries or incidents have been reported.
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