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

Boston Scientific Vercise Deep Stimulation Burr Hole Cover Kits Recall: Risk of Procedure

Boston Scientific recalls Burr Hole Cover Kits (REF: M365DB4600C0 and M365DB4605C0) for potential procedure delays or additional surgery due to locking mechanism issues in Deep Brain Stimulation systems.

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

🇺🇸 FDA recall #Z-2340-2025Medical deviceBoston Scientific ›
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Contact the company

Recalling firmBoston Scientific Neuromodulation Corporation25155 Rye Canyon Loop · Valencia, CA 91355-5004
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling two burr hole cover kits used with their Vercise Deep Stimulation System. The kits may cause procedure delays or require additional surgery if the locking mechanism doesn't close properly. Read more at govinfonow.com/recall/51831-boston-scientific-vercise-deep-stimulation-burr-hole-cover-kits-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/51831-boston-scientific-vercise-deep-stimulation-burr-hole-cover-kits-recall · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2340-2025

Cite this page

“Boston Scientific Vercise Deep Stimulation Burr Hole Cover Kits Recall: Risk of Procedure.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51831-boston-scientific-vercise-deep-stimulation-burr-hole-cover-kits-recall. Based on FDA recall #Z-2340-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2340-2025%22&limit=1).

Boston Scientific Neuromodulation Corporation recalled Burr Hole Cover Kits and Spares Kits used in Deep Brain Stimulation systems on July 8, 2025. The Food and Drug Administration announced the Class II recall due to potential locking mechanism failures that could cause procedural delays or lead migration.

How to tell if you have it

  • Burr Hole Cover Kit, REF: M365DB4600C0
  • Burr Hole Cover Spares Kit, REF: M365DB4605C0
  • Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802
  • Surgical Implant Manual version REF/UDI-DI: M365DB4605C0/08714729820819

The hazard

The FDA said resistance and difficulties could occur while closing the retaining clip locking mechanism. This defect may lead to procedural delays or lead migration, which may require additional surgery.

Context

GovInfoNow's records show Boston Scientific Neuromodulation Corporation has 12 other recalls on record since April 24, 2019. Other recent recalls of similar products include the INFINION CX Lead Kits Recall (June 17, 2026), the SC-4318 Clik X Anchor Recall (April 29, 2026), and the CSK Electrodes Recall (April 29, 2026). Additional recent recalls include the Transcarotid Kit Sheath Depth Markings May Detach recall (June 26, 2026), the OverStitch Suture Cinch Recall (July 14, 2026), and the ENROUTE Transcarotid Neuroprotection System Recall (July 9, 2026).

How to tell if you have this one

Check if your Vercise Deep Stimulation System includes the Burr Hole Cover Kit with REF: M365DB4600C0 or Burr Hole Cover Spares Kit with REF: M365DB4605C0. These kits were used with the Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802 or M365DB4605C0/08714729820819.

  • Brand
    Boston Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit References

    Identify if your Vercise Deep Stimulation System includes the Burr Hole Cover Kit (REF: M365DB4600C0) or Burr Hole Cover Spares Kit (REF: M365DB4605C0).

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

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 50 days after the firm started it.

1. Firm started the recall: Jul 8, 202512. FDA classified it Class II: Aug 19, 202523. Published in FDA’s Enforcement Report: Aug 27, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-2340-2025 (July 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2340-2025 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA