Boston Scientific recalls PROPONENT MRI pacemakers (L210, L211, L231) not approved in the US due to intermittent over-sensing of Minute Ventilation sensor signals.
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 certain PROPONENT MRI pacemakers (L21: L210, L211, L231) that are not approved for use in the US. These devices may cause intermittent over-sensing of the Minute Ventilation sensor signal, which could lead to improper pacing.
The pacemakers may intermittently misinterpret the Minute Ventilation (MV) sensor signal, causing the device to pace incorrectly. This could lead to improper heart function management.
Owners of the recalled PROPONENT MRI pacemakers (L210, L211, L231) in the US are affected. Patients with these specific pacemaker models are at risk of improper pacing due to the sensor issue.
Check if your pacemaker model is L210, L211, or L231. These devices are not approved for use in the United States and were sold outside the US.
Identify your pacemaker model to see if it is L210, L211, or L231.
No, these pacemakers (L210, L211, L231) are not approved for use in the United States.
These pacemakers may cause intermittent over-sensing of the Minute Ventilation sensor signal, potentially leading to improper pacing.
The recall does not require stopping use; however, you should check your model number and contact Boston Scientific 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-0377-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0377-2018 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.
