Boston Scientific recalls VISIONIST X4 CRT-P pacemakers (Model U228) 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 VISIONIST X4 CRT-P pacemakers (Model U22:8) because they may intermittently over-sense Minute Ventilation sensor signals. This could lead to improper heart rhythm management, potentially causing health issues for users.
The pacemaker may incorrectly interpret Minute Ventilation sensor signals, leading to improper heart rhythm adjustments. This could cause the device to malfunction and potentially affect heart function.
Pacemaker users with the VISIONIST X4 CRT-P model (U228) are affected. Those with cardiac conditions requiring pacemaker therapy are most at risk.
Check for the VISIONIST X4 CRT-P pacemaker model U228. This device was sold by Boston Scientific Corporation.
Identify if your pacemaker is the VISIONIST X4 CRT-P model U228.
The recall indicates a potential risk of improper heart rhythm management due to intermittent over-sensing, but the exact danger level is not specified in the official notice.
Check for the VISIONIST X4 CRT-P model U228. This device was sold by Boston Scientific Corporation.
The official recall notice does not specify a remedy or action steps beyond checking the model number.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0366-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0366-2018 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.
