Boston Scientific recalled 3,592 units of the Model L221 PROPONENT DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that may prevent proper device functioning due to high battery impedance. Patients and healthcare providers must stop using the device immediately and follow the recall 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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The recall involves the Model L221 PROPONENT DR EL Pacemaker, part of the ACCOLADE family of devices. The devices were distributed worldwide and sold under various serial numbers. The quantity recalled is 3,592 units.
A software issue may prevent initiation of Safety Mode in ambulatory settings. This condition arises due to a high battery impedance state, posing a risk to patient safety.
No specific incidents have been reported in the recall data. However, the software flaw raises significant concerns about potential patient health risks.
Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0090-2026. Patients can also reach Boston Scientific directly for assistance.
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