Boston Scientific recalls ESSENTIO MRI EL DR pacemakers (Model L131) 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 MRI EL DR pacemakers (Model L131) because they may intermittently misread breathing signals, potentially causing incorrect heart rhythm adjustments. This could lead to heart rhythm issues if the device malfunctions.
The pacemaker may incorrectly interpret breathing signals (Minute Ventilation sensor), leading to improper heart rhythm adjustments. This could cause heart rhythm issues if the device malfunctions.
Owners of the ESSENTIO MRI EL DR pacemaker (Model L131) are affected. Patients with pacemakers or cardiac resynchronization therapy devices are most at risk.
Check for the ESSENTIO MRI EL DR pacemaker model L131. This device was sold by Boston Scientific Corporation.
Identify if your pacemaker is the ESSENTIO MRI EL DR model L131.
The recall indicates a potential risk of incorrect heart rhythm adjustments due to intermittent over-sensing of breathing signals, but the remedy is not specified in the record.
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance.
Check for the ESSENTIO MRI EL DR model L131, as this is the specific device recalled.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0372-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0372-2018 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.
