| TGA Action ID |
RC-2025-RN-00388-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CODMAN Disposable Perforator 14mm
Catalogue number: 261221
Lot numbers: 7230534, 7230535, 7233054, 7257262, 7283238 |
| ARTG Number |
336804 |
| Unique Device Identifier (UDI) |
10381780513599 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
During an investigation of complaints, the manufacturer identified that there is an inadequate weld (proud weld) on specific lots of 14mm CODMAN Disposable Perforators that can potentially cause the product to disassemble (break/separate).
Perforator disassembly may occur before, during, or after the craniotomy in devices which have inadequate welds.
If disassembly occurs:
· Before the procedure - It may cause inconvenience to the user and prolong the procedure time.
· During use - If downward pressure is removed or in instances when the outer drill sticks into the cranial bone, the disassembled perforator may need to be removed either manually or using additional surgical instruments.
· During use - Should downward pressure not be removed and a failure to disengage occurs, serious patient injury such as dural tear with haemorrhage (inclusive of sagittal sinus tears with haemorrhage) may occur.
· After use - Upon removal of the perforator from the craniotomy, it may cause inconvenience to the user and prolong the procedure time if additional craniotomies are required.
From the 83 complaints received worldwide, 1 complaint occurred within Australia (reported adverse event).
|
| Instructions for Customers/Users |
Customers are to quarantine affected products to prevent further use.
An Integra Account Manager will be in contact with customers to facilitate the review of inventory, any product return and replacement of product.
If healthcare professionals have already used the product and followed standard operative care, no further patient follow-up is required.
This action has been closed out on 19/01/2026 |
| Action Commencement Date |
24/04/2025 |
| Responsible Entity |
|
| Contact Information |
1300 550 599 - Integra Neurosciences Customer Service |