Boston Scientific recalled 41,009 pacemakers worldwide after a software flaw could prevent Safety Mode activation. The defect affects devices in the ACCOLADE family and several related models. Patients and healthcare providers should stop using the device immediately 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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Pacemakers are implanted devices that regulate heart rhythms. The ACCOLADE family, PROPONENT, ESSENTIO, ALTRUA 2 DR, and CRT-Ps like VISIONIST and VALITUDE are designed to manage heart pacing and synchronization.
A software flaw in Safety Architecture could prevent the device from entering Safety Mode when needed due to high battery impedance, potentially compromising patient safety.
This recall reflects a pattern where software controls in implantable devices affect safety features. It is not described as part of a broader industry recall in the data provided.
Patients may need urgent medical evaluation and device monitoring. The recall requires clinicians to reassess device safety and consider replacement or alternative management.
Refer to the FDA enforcement recall page and Boston Scientific patient resources for device identifiers and instructions
Remedies and replacements are typically processed over weeks to months depending on the case
Save recall letters, maintain a log of communications with clinicians and manufacturers, preserve serial numbers and GTINs, document any adverse events
Brand: Boston Scientific Product: ACCOLADE family pacemakers, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL pacemakers; VISIONIST CRT-Ps; VALITUDE CRT-Ps GTIN: 00802526559082 Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045 Sold through: Worldwide distribution to healthcare providers Sold since: Unknown Price: Unknown
No injuries or incidents have been reported.
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