Boston Scientific recalls ACCOL:EL DR pacemakers (model L321) 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 ACCOLADE EL DR pacemakers (model L321) because they may sense breathing signals incorrectly, potentially causing heart rhythm issues. This could affect users with pacemakers needing precise heart monitoring.
The pacemaker may incorrectly interpret breathing signals as heart activity. This can lead to improper heart rhythm adjustments, which might cause unnecessary pacing or missed heartbeats.
Owners of ACCOLADE EL DR pacemakers (model L321) are affected. Those with pacemakers that rely on Minute Ventilation sensing are most at risk.
Check for the model number L321 on your ACCOLADE EL DR pacemaker. This specific model was recalled by Boston Scientific Corporation.
Identify the model number on your pacemaker; the recalled model is L321.
The recall is for a potential issue with breathing signal sensing, but Boston Scientific states it is low risk and does not require immediate action.
Boston Scientific has not provided a specific remedy for this recall, so you should check with your healthcare provider for guidance.
The affected model is specifically L321; check your pacemaker's model number.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0356-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0356-2018 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.
