Boston Scientific recalls ACCOL: Model L301 pacemakers due to intermittent over-sensing of Minute Ventilation sensor signals, which may cause irregular heart rhythms.
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 DR pacemakers with model L301 because they can sometimes misread breathing signals, potentially causing irregular heart rhythms. This recall affects pacemaker users who have the specific model and may need medical evaluation.
The pacemaker's Minute Ventilation sensor can occasionally misinterpret breathing signals, leading to irregular heart rhythms. This happens because the sensor may detect movement or signals that aren't actual breathing, causing the device to malfunction.
Pacemaker users with the ACCOLADE DR model L301 are most at risk. This recall affects individuals with specific cardiac devices that may experience irregular heart rhythms due to the sensor issue.
Check if your pacemaker has the ACCOLADE DR model L301. The recall covers specific pacemaker systems from Boston Scientific Corporation.
Identify your pacemaker model by checking the device label or documentation.
The recall does not require stopping use; however, you should check if your model is affected and consult your doctor.
Contact Boston Scientific directly to discuss next steps with your healthcare provider.
The recall addresses a potential issue with sensor signals that could cause irregular heart rhythms, but it is not an immediate safety risk.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0355-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0355-2018 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.
