Boston Scientific recalls ACCOL: MRI SR Pacemaker model L310 due to intermittent over-sensing of Minute Ventilation sensor signals, which may cause incorrect pacing.
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 its ACCOLADE MRI SR Pacemaker model L310 because it can sometimes misread the Minute Ventilation sensor signal. This could lead to incorrect pacing, potentially causing health issues for users.
The pacemaker may intermittently misread the Minute Ventilation sensor signal, leading to incorrect pacing. This could cause the device to function improperly, potentially affecting heart rhythm.
Pacemaker users with the ACCOLADE MRI SR Pacemaker model L310 are affected. Those with cardiac conditions requiring pacemakers are most at risk.
Check for the ACCOLADE MRI SR Pacemaker model L310. This product was sold by Boston Scientific Corporation.
Identify if your pacemaker is model L310.
The recall is for a potential issue with sensor signal interpretation, but it does not indicate immediate danger to users.
The official recall does not specify a remedy, so contact Boston Scientific for guidance.
Check for the model number L310 on your ACCOLADE MRI SR Pacemaker.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0357-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0357-2018 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.
