Boston Scientific recalls Vercise Deep Brain Stimulation Systems with wire breaks that prevent proper function, risking loss of therapy and symptoms return. Affected units have specific UDI-DI numbers.
Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.
Boston Scientific is recalling Vercise Deep Brain Stimulation Systems that have wire breaks. This can cause the device to stop working, leading to loss of therapy and return of symptoms.
Wire breaks in the device prevent proper stimulation, causing the device to stop working. This can lead to loss of therapy, return of symptoms, and Bluetooth connectivity issues.
People with Vercise Deep Brain Stimulation Systems implants in the pectoral area. Those who experience loss of therapy or return of symptoms are most at risk.
Check for UDI-DI numbers 08714729985044 or 08714729985051 on the device. The recall document number is 92328632-09, Revision A.
Look for UDI-DI numbers 08714729985044 or 08714729985051 on the device.
Wire breaks in the rechargeable deep brain stimulation implantable pulse generators can prevent successful stimulation, causing loss of therapy and return of symptoms.
Check for UDI-DI numbers 08714729985044 or 08714729985051. If affected, contact Boston Scientific for further instructions.
Yes, but if you experience loss of therapy or return of symptoms, contact Boston Scientific immediately.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2558-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2558-2025 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.