Boston Scientific Neuromodulation Corporation recalls Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

Recall date

July 8, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2558-2025

FDA classification

Class II

Brand / firm

Boston Scientific Neuromodulation Corporation

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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