Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Sold At: Boston Scientific Neuromodulation Corporation(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.)
Recall #: FDA-DEVICE-Z-2558-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A
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Summary
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 next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Boston Scientific Neuromodulation Corporation for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.