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SureTek recallZ-2340-2025 · Boston Scientific Neuromodulation Corporation · initiated Jul 8, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Neuromodulation Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Component change control

What the company is doing

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]

Recall details

Recall number
Z-2340-2025
Status
Open, Classified
Initiated by the company
Jul 8, 2025
Posted by the FDA
Aug 19, 2025
Recalling firm
Boston Scientific Neuromodulation Corporation
Quantity
24,583
Product code
NHL
FDA submissions
P150031
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 description

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

Code information (models, lots, serial numbers)

All lots. Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802, M365DB4605C0/08714729820819

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

32 devices cleared under P150031 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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