Boston Scientific recalls specific ALTRUA 2 DR EL pacemakers due to potential safety software issues. Affected models include certain serial numbers and GTINs. No action is required for safe use.
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 ALTRUA 2 DR EL pacemakers that may have software issues affecting safety. The recall does not require immediate action as the software update is designed to prevent safety mode activation.
The software update prevents the pacemaker from entering safety mode due to high battery impedance states. This could potentially cause the device to malfunction in certain conditions, but the update resolves this issue.
Pacemaker users with the specific serial numbers listed in the recall. Most users are not at risk as the issue is addressed by a software update.
Check if your pacemaker has the specific serial numbers listed in the recall (e.g., 100037, 100039, 700442, etc.) or the GTIN numbers provided.
Review the serial numbers and GTINs listed in the recall to determine if your device is affected.
No action is required as the software update is designed to prevent safety mode activation. The recall does not require immediate action.
The software update addresses potential safety mode activation due to high battery impedance states, which could affect device function.
Compare your device's serial numbers and GTINs with the list provided in the recall.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0100-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0100-2026 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.
