Boston Scientific recalls ESSENTIO MRI DR pacemakers (Model L111) due to intermittent over-sensing of Minute Ventilation sensor signals, which may cause improper pacing.
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 DR pacemakers (Model L111) because they can sometimes misread breathing signals, potentially causing incorrect pacing. This could lead to health issues if the device malfunctions.
The pacemaker may incorrectly interpret breathing signals, leading to improper pacing. This could cause irregular heartbeats or other complications if the device malfunctions.
Pacemaker users with the ESSENTIO MRI DR model (L111) are affected. Those with cardiac conditions requiring pacemakers are most at risk.
Check if your pacemaker is labeled 'ESSENTIO MRI DR' and model number L111. This specific model was sold by Boston Scientific.
Identify if your pacemaker is the ESSENTIO MRI DR model with serial number L111.
Reach out to Boston Scientific for guidance on next steps if you have the recalled model.
The recall involves intermittent over-sensing of breathing signals, which may cause improper pacing. While not immediately life-threatening, it could lead to health issues if the device malfunctions.
Check for the model 'ESSENTIO MRI DR' and serial number L111. This specific model was recalled by Boston Scientific.
Contact Boston Scientific directly for guidance on next steps. The recall does not require immediate action but should be addressed.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0370-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0370-2018 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.
