CLASS II ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report
Burr Hole Cover Kit recalled by Boston Scientific
Boston Scientific Neuromodulation is recalling Burr Hole Cover Kit, distributed nationwide in the US. The recall was initiated on 8 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2340-2025
- FDA event ID
- 96916
- Recalling firm
- Boston Scientific Neuromodulation, Valencia, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jul 2025
- FDA classified
- 19 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 8 Jul 2025 | Recall initiated by company | |
| 19 Aug 2025 | Classified by FDA | +42 days |
| 27 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.
Product as listed by the FDA
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
Where it was 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 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, T¿rkiye, UAE, Ukraine, United Kingdom, Canada, Japan, Argentina, Brazil, Chile, Colombia , Ecuador, Mexico, Hong Kong, China, India, Singapore, Korea, Taiwan.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.
Which lots are affected?
All lots. Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802, M365DB4605C0/08714729820819
Where was it sold?
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 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, T¿rkiye, UAE, Ukraine, United Kingdom, Canada, Japan, Argentina, Brazil, Chile, Colombia , Ecuador, Mexico, Hong Kong, China, India, Singapore, Korea, Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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