| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00312-1 |
| Product Name/Description |
Cobalt XT HF Cardiac Resynchronization Therapy Defibrillator Evera XT DR Defibrillator
Multiple products, lot numbers, CFN and material numbers.
ARTG's 230021, 341553, 341549 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic identified devices that may have undergone a specific manufacturing sequence that requires additional engineering evaluation.
The specific sequence utilised a component lot obtained from a supplier, where a subset of this lot has the potential to be inconsistent with specification.
If this component were to fail, it may lead to an impact to device function and/or require device replacement.
To date no complaints have been reported, and all distributed devices met functional test requirements.
Current analysis indicates that the affected devices are unlikely to have been manufactured with the component being evaluated. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers need to be made aware that:
- A Medtronic Representative will collect the device(s) and arrange for replacement(s) after receiving the signed acknowledgement form.
- In the unlikely event that a patient has received one of the four identified devices, there are no recommended changes to the standard follow-up care protocol.
- Medtronic advice that further investigation and engineering evaluations are ongoing, and that more information will be provided to customers if further action is necessary as determined by the ongoing engineering evaluation.
This action has been finalised on 16/7/2024. |
| Contact Information |
ilan.fogel@medtronic.com - Ilan Fogel |