Boston Scientific recalls VALITUDE CRT-P pacemakers (Model U125) due to intermittent over-sensing of Minute Ventilation sensor signals, which may cause improper heart rhythm management.
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 VALITUDE CRT-P pacemakers (Model U12:5) because they may sense breathing signals incorrectly, potentially causing improper heart rhythm management. This could lead to health issues for users with pacemakers.
The pacemaker may incorrectly interpret breathing signals as heart activity. This can cause the device to adjust heart rhythm improperly, potentially leading to health issues.
People with VALITUDE CRT-P pacemakers (Model U125) are affected. Those with pacemakers that use the Minute Ventilation sensor are most at risk.
Check if your pacemaker model is U125. The device is sold by Boston Scientific Corporation.
Identify your pacemaker model to confirm if it is U125.
The recall is for potential improper heart rhythm management due to incorrect breathing signal sensing, but the risk level is low.
Check your pacemaker model; if it is U125, contact Boston Scientific for further instructions.
The affected device is the VALITUDE CRT-P pacemaker with model U125, sold by Boston Scientific Corporation.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0360-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0360-2018 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.
