Boston Scientific recalls Model L209 Proponent DR (VDD) SL pacemakers with serial numbers listed in the record. Software update prevents safety mode activation due to high battery impedance. Affected units include specific serial numbers and GTIN 00802526559068.
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 (VDD) SL pacemakers due to a software issue that could cause the device to enter safety mode in certain conditions. This recall involves a limited set of units with specific serial numbers and a GTIN code. The software update addresses the risk of unintended safety mode activation.
The software issue could cause the pacemaker to enter safety mode when the battery impedance is unusually high. This is part of the ACCOLADE family of devices, which includes several pacemaker models. Safety mode is a protective feature that may temporarily stop the device from pacing if it detects a problem, but in this case, the issue is related to battery conditions.
Pacemaker users with the specific Model L209 Proponent DR (VDD) SL pacemakers listed in the serial numbers and GTIN 00802526559068. Most users are unlikely to be affected as only a small number of units are included in this recall.
Check if your pacemaker has the Model Number L209 Proponent DR (VDD) SL and the specific serial numbers listed in the recall record (e.g., 100002, 100006, etc.) or the GTIN 00802526559068.
Verify your pacemaker model and serial number against the list provided in the recall record.
If your device is listed, contact Boston Scientific directly for instructions on the software update.
Boston Scientific identified a software issue that could cause the pacemaker to enter safety mode due to high battery impedance. This update prevents unintended safety mode activation.
No action is needed if your device is not on the list of affected serial numbers or GTIN.
Compare your device's serial number with the list of affected serial numbers provided in the recall record.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0087-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0087-2026 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.
