Boston Scientific recalls specific ESSENTIO pacemaker models due to potential early battery depletion from hydrogen, requiring replacement to prevent premature failure.
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 certain ESSENTIO pacemaker models because hydrogen in the battery may cause faster battery depletion, leading to early replacement. This could result in the device failing before its intended lifespan.
The pacemaker's battery may deplete faster than expected due to hydrogen in the battery chemistry. This could cause the device to fail prematurely, requiring early replacement.
Pacemaker users with the recalled ESSENTIO models (L100, L101, L110, L11:1, L121, L131) are affected. Patients with these specific models face a risk of early battery depletion.
Check if your pacemaker model is listed: ESSENTIO SR L100, ESSENTIO DR L101, ESSENTIO MRI SR L110, ESSENTIO MRI DR L111, ESSENTIO EL DR L121, or ESSENTIO MRI EL DR L131. These models were sold with the specific battery chemistry.
Reach out to Boston Scientific directly to confirm your model and schedule a replacement.
No, the recall does not require immediate discontinuation of use. The device can continue functioning but may need replacement sooner than expected.
The affected models are ESSENTIO SR L100, ESSENTIO DR L101, ESSENTIO MRI SR L110, ESSENTIO MRI DR L111, ESSENTIO EL DR L121, and ESSENTIO MRI EL DR L131.
The battery may deplete faster than normal, potentially requiring early replacement to prevent device failure.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3255-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3255-2018 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.
