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

FDA device recall Z-2340-2025 · posted 2025-08-19 · Open, Classified

Recall details

Recalling firm

Boston Scientific Neuromodulation Corporation

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.

Action taken

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 BSCFieldActionCenter@bsci.com 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 BSN.ComplaintCallCenter@bsci.com

Root cause

Component change control

Status

Open, Classified

Product code

NHL

Quantity affected

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

Date initiated

2025-07-08

Date posted

2025-08-19

Location

Valencia, CA