Boston Scientific recalls ACCOLADE pacemakers with hydrogen-induced battery depletion risk. Affected models include L300, L310, L311, L321, L331. Contact for replacement.
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Boston Scientific is recalling specific ACCOLADE pacemaker models due to a risk of early battery depletion from hydrogen exposure. This could lead to premature pacemaker replacement. Affected users should contact the company for a replacement.
The pacemaker's battery may deplete faster than expected due to hydrogen exposure. This could require early replacement, but it does not cause immediate injury or death.
Pacemaker users with the listed ACCOLADE models are affected. Those with older pacemakers or different models are not at risk.
Check if your pacemaker model is listed: ACCOLADE SR L300, DR L311, MRI SR L310, MRI DR L311, EL DR L321, or MRI EL DR L331. These models were sold between 2018 and 2020.
Reach out to Boston Scientific for a replacement pacemaker.
No, the recall does not require stopping use. Contact Boston Scientific for a replacement.
Affected models include ACCOLADE SR L300, DR L311, MRI SR L310, MRI DR L311, EL DR L321, and MRI EL DR L331.
The recall describes a risk of early battery replacement, not immediate injury or death.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3257-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3257-2018 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.
