Boston Scientific recalls VALITUDE X4 CRT-P pacemakers with potential battery depletion due to hydrogen. Owners should contact for evaluation.
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Boston Scientific is recalling VALITUDE X4 CRT-P pacemakers that may experience early battery depletion. This could lead to the need for replacement before expected lifespan.
The pacemaker system may deplete its battery faster than normal due to hydrogen buildup. This could require earlier replacement than intended, potentially causing health issues.
Owners of VALITUDE X4 CRT-P pacemakers with model U128 are affected. Patients with cardiac conditions requiring pacemakers are most at risk.
Check for the VALITUDE X4 CRT-P model U12:8 on your device. This recall applies to pacemakers sold with this specific model number.
Reach out to Boston Scientific for evaluation of your device's battery condition.
Boston Scientific identified a subset of VALITUDE X4 CRT-P pacemakers with an elevated potential for early battery replacement due to hydrogen-induced accelerated battery depletion.
Look for the VALITUDE X4 CRT-P model U128 on your device. This specific model is part of the recall.
Contact Boston Scientific for evaluation of your device's battery condition.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3258-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3258-2018 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.
