Boston Scientific recalls specific PROPONENT DR EL pacemakers with potential safety software issues that could cause unintended safety mode activation. Affected models include ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber pacemakers.
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 PROPONENT DR EL pacemakers due to a software issue that could cause unintended activation of safety mode in certain conditions. This may lead to improper heart rhythm management. The recall covers specific model numbers and serial ranges.
The software issue can cause the pacemaker to enter safety mode when the battery impedance is high, which may lead to improper heart rhythm management. This is a potential risk during normal use but does not cause immediate harm.
Pacemaker users with the specific PROPONENT DR EL models listed in the recall are affected. Patients with other ACCOLADE, ESSENTIO, ALTRUA 2, or VISIONIST/VALITUDE devices may also be impacted if they have the same serial numbers.
Check your pacemaker model number and serial numbers against the list provided in the recall. The affected models include PROPONENT DR EL pacemakers with specific GTINs and serial numbers listed in the document.
Review your pacemaker's model number and serial numbers against the list of affected units provided in the recall.
If your device is listed, contact Boston Scientific directly for further instructions on software updates or device replacement.
No replacement is required. Boston Scientific will provide a software update to address the issue.
Check your device's model number and serial numbers against the specific list of affected units provided in the recall document.
Yes, the recall includes ACCOLADE, ESSENTIO, ALTRUA 2 dual chamber pacemakers, and VISIONIST/VALITUDE cardiac resynchronization therapy pacemakers with the same serial numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0090-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0090-2026 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.
