Boston Scientific recalled 10,833 pacemakers worldwide after a software issue could block Safety Mode in an ambulatory setting. The defect affects the ACCOLADE family and related devices, including VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately 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 regulate heart rhythm and are implanted devices monitored by clinicians. They are critical for patients with rhythm disorders and rely on software to manage safety features.
The recall concerns software intended to enhance Safety Architecture. If the software fails to initiate Safety Mode during high battery impedance, it can compromise device safety in real-world use.
This recall is not described as part of a broader industry pattern in the provided data.
Patients with affected devices may require medical follow-up or device replacement. The recall affects 10,833 units and has implications for clinical scheduling and patient safety.
Details are available on the FDA recall page and through your healthcare provider. Look for model numbers and serials on hospital records and device labels.
Replacements and next steps are coordinated through healthcare providers. Timelines vary by patient and hospital capacity.
Maintain copies of all recall communications, hospital correspondence, and any scheduling notices. Document any device-related symptoms and medical consultations
Brand: Boston Scientific. Model numbers include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL, ALTRUA 2 DR EL, VISIONIST, VALITUDE. Sold worldwide through hospitals and medical distributors. Price and sale dates not disclosed. Volume recalled: 10,833 units.
No injuries or incidents have been reported.
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