Boston Scientific recalls Propion EL DR pacemakers (Model L221) 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 specific pacemakers (Model L22:21) because they can sometimes misread breathing signals, potentially leading to incorrect heart rhythm adjustments. This could affect pacemaker users who rely on accurate monitoring of their breathing patterns.
The pacemaker may occasionally misinterpret breathing signals from the Minute Ventilation sensor, causing it to adjust heart rhythm incorrectly. This could lead to improper heart rate management if the device misreads the user's breathing patterns.
Pacemaker users with Boston Scientific's Propion EL DR model (L221) are most at risk. This recall affects individuals with specific cardiac devices that monitor breathing patterns.
Check if your pacemaker has the model number L221. This specific model was sold by Boston Scientific Corporation.
Identify your pacemaker model to see if it matches the recalled L221 model.
The recall is for a potential misreading of breathing signals, which could lead to incorrect heart rhythm adjustments. However, the risk is low and not immediately dangerous for most users.
Check if your pacemaker model is L221, as this specific model was recalled by Boston Scientific.
The recall does not require immediate action. Check your model and contact Boston Scientific for further guidance if needed.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0375-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0375-2018 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.
