BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2558-2025 · Initiated July 8, 2025

    Recall

    Recall Number
    Z-2558-2025
    Event Number
    97144
    Firm
    Boston Scientific Neuromodulation Corporation
    FEI Number
    3006630150
    Product Code
    NHL
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    July 8, 2025
    Posted
    September 12, 2025
    Address
    25155 Rye Canyon Loop, Valencia, CA, 91355-5004

    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.

    Action

    On 7/8/2025, correction notices were mailed in the U.S. and mailed, emailed, or hand delivered outside the U.S. Healthcare Professionals were asked to do the following: 1) Review the Surgical Implant Manual updates. 2) If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. 3) A patient letter is enclosed with this communication, which can be shared with your patient and/or included within the patient's medical record. 4) Monitor per relevant IFU recommendations for any clinical observations of high monopolar impedances, undesired sensation, sudden loss of therapy, return of pre-implant symptoms and/or Bluetooth connectivity challenges, as these may be signals of potential feedthrough wire break(s) (component damage). 5) If you are a distributor, this notification must be forwarded to your customers to ensure this notification is carried out to the end-user level. 6) To provide awareness of this information, share this letter with any other clinicians in your hospital who use the system. 7) Maintain a copy of this letter in your facility's records. 8) Complete and return the acknowledgement form via email to [email protected] report all device-related incidents or quality concerns experienced with the use of these devices to the firm at [email protected]

    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