Boston Scientific recalls ESSENTIO EL DR pacemakers (Model L121) due to intermittent over-sensing of Minute Ventilation sensor signals, which may cause improper heart rhythm management.
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Boston Scientific is recalling ESSENT:IO EL DR pacemakers (Model L121) because they may sense breathing signals incorrectly, potentially causing improper heart rhythm control. This could lead to health issues for users with pacemakers.
The pacemaker may incorrectly interpret breathing signals from the Minute Ventilation sensor, leading to improper heart rhythm adjustments. This could cause the device to malfunction and affect heart function.
People with ESSENTIO EL DR pacemakers (Model L121) who have a heart condition requiring a pacemaker are affected. Those with cardiac resynchronization therapy pacemakers using this model are most at risk.
Check if your pacemaker model is ESSENTIO EL DR with serial number L121. The device was sold by Boston Scientific Corporation.
Identify if your pacemaker is the ESSENTIO EL DR model with serial number L121.
The recall is for potential improper heart rhythm adjustments due to sensor signal issues, but it is classified as low risk.
Check if your pacemaker is the ESSENTIO EL DR model with serial number L121.
The recall does not specify a remedy, so contact Boston Scientific for further guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0371-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0371-2018 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.
