Use caution Medical device recall · FDA · Published July 8, 2025

Boston Scientific Vercise Deep Brain Stimulation Systems Recall: Wire Breaks Cause Device

Boston Scientific recalls Vercise Deep Brain Stimulation Systems with wire breaks that prevent proper function, risking loss of therapy and symptoms return. Affected units have specific UDI-DI numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2558-2025Medical device Boston Scientific ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBoston Scientific Neuromodulation Corporation25155 Rye Canyon Loop · Valencia, CA 91355-5004

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling Vercise Deep Brain Stimulation Systems that have wire breaks. This can cause the device to stop working, leading to loss of therapy and return of symptoms. Read more at govinfonow.com/recall/51832-boston-scientific-vercise-deep-brain-stimulation-systems-recall-wire-breaks.

Source Summary by GovInfoNow · govinfonow.com/recall/51832-boston-scientific-vercise-deep-brain-stimulation-systems-recall-wire-breaks · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2558-2025

Cite this page

“Boston Scientific Vercise Deep Brain Stimulation Systems Recall: Wire Breaks Cause Device.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51832-boston-scientific-vercise-deep-brain-stimulation-systems-recall-wire-breaks. Based on FDA recall #Z-2558-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2558-2025%22&limit=1).

Boston Scientific Neuromodulation Corporation recalled Vercise Deep Brain Stimulation Systems Surgical Implant Manuals, Document Number 92328632-09, due to wire break hazards in associated devices. The Food and Drug Administration announced the recall on July 8, 2025.

How to tell if you have it

Brand: Boston Scientific
Product: Vercise Deep Brain Stimulation Systems Surgical Implant Manual
Document Number: 92328632-09
UDI-DI: 08714729985044, 08714729985051
Revision: Rev A

The hazard

Wire breaks in rechargeable deep brain stimulation implantable pulse generators prevent successful stimulation. Users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms, and Bluetooth connectivity challenges.

Context

GovInfoNow's records show Boston Scientific Neuromodulation Corporation has 12 other recalls on record since April 24, 2019. Other recent recalls include the Boston Scientific INFINION CX Lead Kits Recall (June 17, 2026), the Boston Scientific CSK Electrodes Recall (April 29, 2026), and the Boston Scientific SC-4318 Clik X Anchor Recall (April 29, 2026). Similar recent recalls of other products include the Boston Scientific Rapid Refill System recall (June 30, 2026), the Hamilton Medical IntelliCuff Recall (May 22, 2026), and the Maquet Bubble Sensor Recall (January 9, 2026).

How to tell if you have this one

Check for UDI-DI numbers 08714729985044 or 08714729985051 on the device. The recall document number is 92328632-09, Revision A.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Status
Look for UDI-DI numbers 08714729985044 or 08714729985051 on the device.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jul 8, 2025Firm started the recall
Sep 12, 2025FDA classified it Class II
Sep 24, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/51832-boston-scientific-vercise-deep-brain-stimulation-systems-recall-wire-breaks">Boston Scientific Vercise Deep Brain Stimulation Systems Recall: Wire Breaks Cause Device (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2558-2025 (July 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2558-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.