| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00834-1 |
| Product Name/Description |
Impella 5.5 with SmartAssist heart pumps
Item code: 0550-0007
Serial numbers: 425332, 463954, 425331, 425570
ARTG 386932
Abiomed Australia Pty Ltd - Impella 5.5 with SmartAssist - Intracardiac circulatory assist axial-pump catheter |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/09/2023 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This can result in low flow from the damaged Impella system.
No incidences of the Impella 5.5 with SmartAssist Pump interacting with transcatheter aortic valve (TAV) have been reported to the sponsor. The actual design of the pump outlet of the Impella 5.5 heart pump minimises the possibility for any such interaction. To reduce the risk completely, the instructions for use (IFU) are being updated to include a warning statement to avoid interaction with the TAV prosthesis. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The affected customer is to familiarise themselves with the updated warning added to the IFU and attach the updated IFU to stock in their facility
This action has been finalised on 23/7/2024.. |
| Contact Information |
TBC |