Boston Scientific Neuromodulation recalled 25,260 deep brain stimulation systems on July 8, 2025, due to wire break issues. Users may experience loss of therapy and other serious complications. Patients should stop using the devices immediately and seek further instructions.
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
The recalled devices are the Vercise Deep Brain Stimulation Systems with Document Number 92328632-09. They were distributed worldwide, including across 50 states in the U.S. and multiple countries. The devices are classified as a Class II medical device.
Wire breaks in the pulse generators can prevent successful stimulation, leading to high monopolar impedances and loss of therapy. Users might also experience undesired sensations and Bluetooth connectivity issues.
As of the recall date, there are no specific injury reports, but the potential for significant complications exists due to the nature of the malfunction.
Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Neuromodulation Corporation or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2558-2025.
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