Boston Scientific recalls PROPONENT SR pacemakers (Model L200) 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 SR pacemakers (Model L2:00) because they may incorrectly sense minute ventilation signals, potentially causing improper heart rhythm management. This could lead to unintended heart rhythm changes if the device malfunctions.
The pacemaker may incorrectly detect minute ventilation signals, causing it to adjust heart rhythm improperly. This could lead to unintended heart rhythm changes if the device malfunctions.
Pacemaker users with the PROPONENT SR model (L200) are affected. Those with cardiac resynchronization therapy pacemakers using this model are at higher risk.
Check if your pacemaker is labeled 'PROPONENT SR' and model number L200. This model was sold by Boston Scientific.
Identify if your pacemaker is the PROPONENT SR model with L200 designation.
The recall indicates a potential for improper heart rhythm management due to signal over-sensing, but the risk level is low.
Check your pacemaker model; if it matches, contact Boston Scientific for guidance.
Look for the 'PROPONENT SR' label and model number L200 on your device.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0373-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0373-2018 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.