Boston Scientific recalls ESSENTIO MRI SR pacemakers (model L110) due to intermittent over-sensing of Minute Ventilation sensor signals, which may cause incorrect heart rhythm adjustments.
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 SR pacemakers (model L110) because they can sometimes misread breathing signals, potentially causing incorrect heart rhythm adjustments. This could lead to unintended heart rate changes for users with pacemakers.
The pacemaker can sometimes misinterpret breathing signals from the Minute Ventilation sensor, causing it to adjust heart rhythm incorrectly. This may lead to unintended heart rate changes that could affect heart function.
People with ESSENTIO MRI SR pacemakers (model L110) who have a heart condition requiring a pacemaker are affected. Those with cardiac resynchronization therapy pacemakers using this model are at higher risk.
Check if your pacemaker has the model number L110 on the device label. The ESSENTIO MRI SR pacemaker is sold by Boston Scientific Corporation.
Look for the model number L110 on your pacemaker device label.
No, this recall specifically affects ESSENTIO MRI SR pacemakers with model number L110.
Check your pacemaker model number; if it's L110, contact Boston Scientific for further instructions.
The recall states there are reports of intermittent over-sensing, but no specific injuries have been reported. The risk is not described as causing serious injury in normal use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0369-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0369-2018 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.
