Boston Scientific recalls ACCOL: MRI DR pacemakers with model L311 due to intermittent over-sensing of Minute Ventilation sensor signals. This may cause incorrect heart rhythm readings.
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 DR pacemakers with model L311 because they may cause incorrect heart rhythm readings due to intermittent over-sensing of the Minute Ventilation sensor signal. This could lead to improper heart pacing.
The pacemaker may incorrectly sense the Minute Ventilation sensor signal, leading to improper heart pacing. This could cause the device to malfunction and deliver incorrect signals to the heart.
Pacemaker users with the ACCOLADE MRI DR model L311 are affected. Those with cardiac conditions requiring pacemakers are most at risk.
Check if your pacemaker is labeled 'ACCOLADE MRI DR' with model number L311. This model was sold by Boston Scientific.
Identify your pacemaker model by checking the label on the device. If it says 'ACCOLADE MRI DR' with model L311, it is affected.
The recall is for potential incorrect heart rhythm readings due to intermittent over-sensing of the Minute Ventilation sensor signal, but it is not stated to cause serious injury or death.
Check the label on your pacemaker for 'ACCOLADE MRI DR' with model number L311. This 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-0358-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0358-2018 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.
