Boston Scientific recalls ACCOL: MRI EL DR Pacemaker model L331 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 ACCOLADE MRI EL DR Pacemaker model L331 because it can intermittently misread Minute Ventilation sensor signals, potentially causing incorrect pacing. This could lead to health issues if the device malfunctions.
The pacemaker may incorrectly interpret Minute Ventilation sensor signals, leading to improper pacing. This could cause the device to malfunction and potentially cause health issues for users.
Pacemaker users with model L331 ACCOLADE MRI EL DR Pacemakers are affected. Those with cardiac conditions requiring pacemaker therapy are at higher risk.
Check if your pacemaker is labeled 'ACCOLADE MRI EL DR' and model number L331. This specific model was sold by Boston Scientific.
Identify your pacemaker model by checking the device label for 'ACCOLADE MRI EL DR' and model number L331.
The recall is due to intermittent over-sensing of Minute Ventilation sensor signals, which may cause incorrect pacing. This could lead to health issues but does not cause immediate harm.
Check if your pacemaker is labeled 'ACCOLADE MRI EL DR' and model number L331. This specific model was sold by Boston Scientific.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0359-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0359-2018 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.
