Boston Scientific recalls VALITUDE X4 CRT-P pacemakers (Model U128) 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 X4 CRT-P pacemakers (Model U12:8) because they can sometimes misread breathing signals, potentially causing incorrect heart rhythm adjustments. This could lead to heart rhythm issues for users with pacemakers.
The pacemaker may incorrectly interpret breathing signals from the Minute Ventilation sensor, leading to improper heart rhythm adjustments. This could cause heart rhythm issues for users with pacemakers.
People with VALITUDE X4 CRT-P pacemakers (Model U128) who have a pacemaker or cardiac resynchronization therapy device are affected. Those with specific pacemaker models are at higher risk.
Check if your pacemaker is labeled 'VALITUDE X4 CRT-P' with model number U128. This recall applies to pacemakers sold by Boston Scientific.
Verify your pacemaker model is VALITUDE X4 CRT-P with U128 designation.
The recall involves a potential risk of incorrect heart rhythm adjustments due to sensor signal misreading, but it is not immediately life-threatening.
Check for the model 'VALITUDE X4 CRT-P' with serial number U128 on your pacemaker.
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-0361-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0361-2018 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.
