Boston Scientific recalls PROPONENT DR pacemakers (Model L2:201) 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 PROPONENT DR pacemakers (Model L201) because they may sense ventilation signals incorrectly, potentially leading to improper heart rhythm management. This could affect users who rely on these devices for heart health.
The pacemaker may incorrectly sense ventilation signals, causing it to malfunction. This could lead to improper heart rhythm management, which might affect how the device responds to the user's heart needs.
Owners of PROPONENT DR pacemakers (Model L201) are affected. Patients with heart conditions who use these devices are most at risk.
Check for the PROPONENT DR pacemaker model L201. This device was sold by Boston Scientific Corporation.
Look for the model number on your pacemaker; affected units are PROPONENT DR with model L201.
The recall is for potential improper heart rhythm management due to incorrect ventilation signal sensing, but it does not indicate immediate risk of serious injury.
Check your device model; if it's PROPONENT DR L201, contact Boston Scientific for guidance.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0374-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0374-2018 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.
