Boston Scientific recalls ESSENTIO SR pacemakers (Model L10:00) 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 ESSENTIO SR pacemakers (Model L100) because they may intermittently misread Minute Ventilation sensor signals, potentially causing improper heart rhythm management. This could lead to unintended heart rate changes or other complications for users.
The pacemaker may incorrectly interpret Minute Ventilation sensor signals, leading to improper heart rhythm adjustments. This could cause unintended heart rate changes or other complications if the device misreads breathing patterns.
Pacemaker users with the ESSENTIO SR model (L100) are affected. Those with cardiac resynchronization therapy systems are at higher risk due to potential misinterpretation of heart signals.
Check if your pacemaker is labeled 'ESSENTIO SR' with model number L100. This model was sold by Boston Scientific Corporation.
Identify your pacemaker model by checking the device label for 'ESSENTIO SR' and model number L100.
No, this recall specifically affects ESSENTIO SR pacemakers with model number L100.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
The recall states intermittent over-sensing may cause improper heart rhythm management, but no specific injury risks are described.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0367-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0367-2018 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.
