BEUDAMED
    FDA Enforcement Class II Ongoing

    Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

    Recall: Z-2558-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2558-2025
    Event ID
    97144
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Neuromodulation Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2025
    Initiation Date
    July 8, 2025
    Classification Date
    September 12, 2025
    Address
    25155 Rye Canyon Loop, N/A, Valencia, CA, 91355-5004, United States

    Description

    Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

    Reason

    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.

    Code Info

    UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A

    Distribution

    Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA, CT, NV, UT, IN, ID, IL, ME, SC, DC, OK, KY, AK, HI, RI, AR, KS, NM and the countries of Argentina, Brazil, Chile, Ecuador, Colombia , Mexico, Canada, Japan, Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkiye, UAE, Ukraine, United Kingdom, Hong Kong, China, Singapore, Korea, Taiwan , India, Thailand.

    Quantity

    25,260