Boston Scientific recalls ACCOL:SR pacemakers with model L300 due to intermittent over-sensing of Minute Ventilation sensor signals. This may cause incorrect heart rhythm readings. Affected users should contact the company for a fix.
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 SR pacemakers with model L300 because they may sense breathing signals incorrectly, potentially causing heart rhythm issues. This is a serious issue for pacemaker users who rely on accurate readings.
The pacemaker may incorrectly interpret breathing signals, leading to improper heart rhythm adjustments. This could cause the device to malfunction and affect heart function.
Pacemaker users with the ACCOLADE SR model L300 are affected. Those with cardiac resynchronization therapy pacemakers using this model are at higher risk.
Check if your pacemaker has the model number L300. The ACCOLADE SR is a specific type of pacemaker used for heart rhythm management.
Reach out to Boston Scientific directly for a fix or replacement.
The recall is for a potential issue with the pacemaker sensing breathing signals incorrectly, which could lead to heart rhythm problems. However, the exact risk level is not specified in the notice.
Check if your pacemaker model is L300. The ACCOLADE SR is the specific type recalled.
Contact Boston Scientific directly for a fix or replacement. The recall does not require immediate action but should be addressed.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0354-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0354-2018 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.
