Recall Z-2340-2025 ยท NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
Boston Scientific Neuromodulation Corporation
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
| Date | Aug 19, 2025 (initiated Jul 8, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| 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 inf |
| Quantity | 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, Belg |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.