Boston Scientific Neuromodulation recalls 25,260 Vercise DBS devices worldwide over wire breaks in rechargeable implantable pulse generators. The defect can prevent stimulation and trigger device removal. Patients should contact their provider for guidance and stop using affected devices immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Neuromodulation Corporation or your healthcare provider for instructions. Notification method: Letter
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Vercise Deep Brain Stimulation Systems provide targeted neural therapy for movement disorders. Devices implanted submuscularly to deliver stimulation.
Wire breaks can interrupt stimulation and cause high impedances, leading to loss of therapy and possible adverse sensations or Bluetooth issues.
This recall is not part of a broader industry pattern.
Urgent medical device issue requiring clinician coordination. Potential for device removal and replacement.
UDI-DI on implant labeling; recall document in FDA enforcement page linked in the notice.
Replacement or remediation timelines vary by patient and clinician guidance; expect medical scheduling coordinated by healthcare providers.
Save recall notice, document communications, and keep device labels and UDI-DI.
Model numbers: UDI-DI 08714729985044 and 08714729985051. Document Number: 92328632-09. Rev A. Distribution: Worldwide. Quantity: 25,260.
No specific incidents or injuries are detailed in the provided recall notice.
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