Boston Scientific recalls 106,536 ACCOLADE family pacemakers sold worldwide through healthcare providers. The recall centers on software designed to strengthen Safety Architecture that could prevent initiating Safety Mode in patients with a high battery impedance state. Patients should stop using the device immediately and contact their clinician or Boston Scientific for 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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Implantable devices that regulate heart rhythm used to treat bradycardia or heart blocks. These devices are implanted by clinicians in adults and certain patients may require MRI compatibility.
A software update intended to improve Safety Architecture could prevent entering Safety Mode in patients with high battery impedance, potentially compromising device safety.
This recall is not described as part of a broader industry pattern.
Patients with affected devices may require medical review and potential device reassessment. The recall emphasizes urgent consultation with clinicians and manufacturer guidance.
Recall letter, FDA enforcement page for Z-0089-2026, and manufacturer site www.bostonscientific.com.
Timelines depend on clinical assessment and device availability; follow recall instructions and clinician guidance.
Keep the recall letter, device model and GTINs, clinical correspondence, and any imaging or medical notes related to device status.
Model: L211 PROPONENT DR SL MRI Pacemaker. GTINs: 00802526559105, 00802526576409, 00802526578038. Sold worldwide through healthcare providers. Recall date: 2025-08-20. Status: ACTIVE. Quantity: 106,536 units. Price: Unknown.
No injuries or incidents have been reported.
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