Boston Scientific recalls VISIONIST CRT-P pacemakers (Models U225 and : intermittent over-sensing of Minute Ventilation sensor may cause improper pacing.
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 CRT-P pacemakers (Models U225 and 226) due to a risk of intermittent over-sensing of the Minute Ventilation sensor signal. This could lead to improper pacing and potential health issues for users.
The pacemaker may incorrectly detect breathing signals, causing it to pace the heart at inappropriate times. This could lead to improper heart rhythm management and potential health complications.
Owners of VISIONIST CRT-P pacemakers with model numbers U225 or 226 are affected. Patients with cardiac conditions requiring pacemakers are most at risk.
Check if your pacemaker model is U225 or 226. The product is sold under Boston Scientific's VISIONIST CRT-P line.
Identify your pacemaker model number to confirm if it is U225 or 226.
The recall indicates a risk of intermittent over-sensing of the Minute Ventilation sensor, which could lead to improper pacing. However, the hazard does not specify immediate danger to health.
The recall does not provide specific action steps. Check the model number and contact Boston Scientific for guidance.
Affected models are U225 and 226. Check your pacemaker's model number to see if it matches.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0365-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0365-2018 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.
