Boston Scientific recalls Proponent DR SL (Model L201) pacemakers with software that may prevent safety mode activation during high battery impedance states. Affected units have specific serial numbers and GTINs. No action is required as the software update is already available.
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).
Boston Scientific is recalling specific models of Proponent DR SL pacemakers (Model L201) due to a software issue that could prevent safety mode activation during high battery impedance states. This recall does not require immediate action as the software update is already available.
The software issue could prevent the pacemaker from entering safety mode when the battery impedance is high, which might lead to improper device function. However, the software update is already available to address this issue.
Patients with Proponent DR SL pacemakers (Model L201) who have the listed serial numbers or GTINs are affected. The risk is low as the software update is already available.
Check if your pacemaker has the Proponent DR SL (Model L201) with the specific serial numbers or GTINs listed in the recall notice. This includes the provided GTINs and serial numbers.
Review your pacemaker's serial numbers and GTINs to confirm if they match the listed affected units.
No action is required as the software update is already available to address the issue.
The affected units include specific serial numbers and GTINs listed in the recall notice.
The risk is low as the software update is already available to prevent the issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0086-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0086-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
