Z-2340-2025Class II

Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise...

Name: Z-2340-2025 Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise...
Creator: Boston Scientific Neuromodulation Corporation
Published: 2025-07-08
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2025-07-08 / Open, Classified

FDA source

Boston Scientific Neuromodulation Corporation began a recall of Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical... on 2025-07-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2340-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-08
Posted: 2025-08-19
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: 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
Product code: NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
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.
FDA root cause: Component change control
Action: On 7/8/2025, correction notices were mailed, emailed, or delivered to healthcare professionals who were asked to do the following: 1. Review the updates to the Surgical Implant Manual stated in this notice. These updates will be found in the IFU once implemented. 2. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. 3. If you are a distributor, this notification must be forwarded to your customers to ensure this notification is carried out to the end-user level. 4. To provide awareness of this information, share this letter with any other clinicians in your hospital who use these devices. 5. If users encounter resistance or difficulties while closing the Retaining Clip locking mechanism, refer to the Surgical Implant Manual updates provided. 6. Maintain a copy of this letter in your facility s records. 7. Complete and return the acknowledgement form via email to [email protected] The Surgical Implant Manual has updates that include: - If you have difficulty locking the Slider, you may need to remove the Lead Stylet before locking the Slider in place, or replace the Retaining Clip using another Burr Hole Cover Kit or Burr Hole Cover Spares Kit. - You may confirm the Slider is fully locked. - Verify that the DBS Lead has not moved from the desired location (e.g. by intraoperative imaging). Report all device-related incidents or quality concerns experienced with the use of these devices to firm at [email protected]
Quantity in commerce: 24,583
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, 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.
Product codes and lots: All lots. Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802, M365DB4605C0/08714729820819

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2340-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2340-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-19

Product code NHL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)