Boston Scientific recalls VISIONIST X4 CRT-P pacemakers with potential for early battery depletion due to hydrogen. Affected models U228 may need replacement.
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 VISION:IST X4 CRT-P pacemakers that could experience early battery depletion. This risk may require premature replacement of the device.
The pacemaker system may deplete its battery faster than expected due to hydrogen buildup. This could lead to the device needing replacement earlier than intended.
Owners of VISIONIST X4 CRT-P pacemakers with model U228 are affected. Patients with cardiac conditions requiring this device are most at risk.
Check for the VISIONIST X4 CRT-P model U228. This device is used for cardiac resynchronization therapy.
Identify your pacemaker model by checking the device label for VISIONIST X4 CRT-P U228.
Boston Scientific identified a subset of VISIONIST X4 CRT-P pacemakers with an elevated potential for early battery depletion due to hydrogen.
Check your device model; if it matches VISIONIST X4 CRT-P U228, contact Boston Scientific for guidance.
The recall addresses potential early battery depletion, not immediate injury risks. The hazard is not described as causing serious injury in normal use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3259-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3259-2018 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.
