Boston Scientific recalls ESSENTIO DR pacemakers (Model L101) 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 DR pacemakers (Model L101) 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 detect breathing signals, leading to improper heart rhythm adjustments. This could cause the device to malfunction and potentially disrupt heart function.
People with ESSENTIO DR pacemakers (Model L101) who have a heart condition requiring a pacemaker are affected. Those with cardiac resynchronization therapy systems using this model are at higher risk.
Check if your pacemaker model is ESSENTIO DR with serial number L101. This model was sold by Boston Scientific for heart conditions requiring pacemakers.
Identify if your pacemaker is the ESSENTIO DR model with serial number L101.
The recall indicates a potential risk of improper heart rhythm management due to incorrect breathing signal sensing, but it does not specify a risk of serious injury.
The recall does not provide specific action steps for affected users, only a model identifier.
Check if your pacemaker is the ESSENTIO DR model with serial number L101, as this is the only model mentioned in the recall.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0368-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0368-2018 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.
