FDAFDA · Food and drugs·Recall number Z-2558-2025
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Published September 24, 2025 · Recall initiated: July 8, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Distributor
- 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.
- Lot
- UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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