Boston Scientific recalls specific VISIONIST CRT-P EL pacemakers due to potential safety mode activation from high battery impedance states. Affected units have unique serial numbers and GTINs listed in the recall notice.
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 VISIONIST CRT-P EL pacemakers that may enter safety mode due to battery issues. This could cause the device to malfunction and potentially lead to health risks for users. Affected units have unique serial numbers and GTINs listed in the recall notice.
The software in these pacemakers may enter safety mode when the battery impedance is too high, which could cause the device to malfunction. This might lead to improper heart rhythm management and potential health risks for users.
Individuals with the recalled VISIONIST CRT-P EL pacemakers (specific models and serial numbers) are most at risk. These devices are used for cardiac resynchronization therapy and may malfunction if the software issue is present.
Check if your device has the model number U226, VISIONIST CRT-P EL, and the specific serial numbers or GTINs listed in the recall notice. The recall covers certain serial numbers and GTINs provided in the official notice.
Review your device's model number and serial numbers to confirm if it's in the recall list provided by Boston Scientific.
Reach out to Boston Scientific directly for further assistance or to confirm if your device is affected.
The specific model being recalled is the VISIONIST CRT-P EL pacemaker with model number U226.
Check your device's serial numbers against the list provided in the recall notice, which includes specific serial numbers and GTINs.
The recall mentions a software update to enhance safety architecture to prevent safety mode initiation, but no specific update instructions are provided in the notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0104-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0104-2026 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.
