Boston Scientific Neuromodulation Corporation 2025-08-27 Health serious FDA
Health · FDA · Recall #FDA-Z-2340-2025
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0.… Recall
Issued August 27, 2025 · Boston Scientific Neuromodulation Corporation
In August 2025, Boston Scientific Neuromodulation Corporation recalled the Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0.…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0.… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Neuromodulation Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boston Scientific Neuromodulation Corporation
- Category
- Health
- Recall date
- August 27, 2025
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-2340-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Neuromodulation Corporation has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.