| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00055-1 |
| Product Name/Description |
The Duet External Drainage and Monitoring System (EDMS)
Multiple Lot Numbers
ARTG 162723
(Medtronic Australasia Pty Ltd - Drainage kit, ventricular) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic received customer complaints alleging instances of the Duet catheter tubing disconnecting at the stopcock or Luer connector.
If a tubing disconnection occurs, potential harm to patients may include infections, cerebrospinal fluid leakage, over drainage of cerebrospinal fluid, and abnormality of the ventricles. Uncontrolled over drainage of cerebral spinal fluid could lead to neurological injury or death if the disconnection is undetected.
The types of patient harms that have been reported in the complaints include cerebrospinal fluid (CSF) leakage and infection. No serious neurological injuries or patient deaths have been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Check stock for affected lot numbers. Return all unused and non-expired product(s) to Medtronic. If applicable, a Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory. |
| Contact Information |
0456 995 887 - Matthew Greig |