| TGA Action ID |
RC-2025-RN-00613-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SureTek Burr Hole Cover Kit
UPN: M365DB4600C0, M365DB4605C0
Surgical Implant Manual Document Number: 92920693 - Vercise DBS Systems - Surgical Implant Manual |
| ARTG Number |
203999 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Boston Scientific received complaints of difficulties while locking SureTekTM Burr Hole Covers (BHC) to secure Deep Brain Stimulation (DBS) Leads, part of the Vercise Deep Brain Stimulation System. In some cases, resistance has been encountered while closing the Retaining Clip locking mechanism to securely hold the lead in place. |
| Instructions for Customers/Users |
Boston Scientific is updating the IFU to guide users if they encounter resistance or difficulties while closing the Retaining Clip locking mechanism.
Meanwhile, customers are to review the updates to the Surgical Implant Manual provided in the Customer Letter and follow outlined recommendations.
This action has been closed out on 21/01/2026 |
| Action Commencement Date |
9/07/2025 |
| Responsible Entity |
|
| Contact Information |
02 8063 8112 - Emma Noble |