| TGA Action ID |
RC-2025-RN-00576-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Impella Controller, Impella Optical Controller, AIC, Optical, Impella Connect
Product codes: 0042-0000-AU, 0042-0000-UK, 0042-0010-AU, 0042-0040-AU
All lots and serial numbers |
| ARTG Number |
288729 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Abiomed has identified an Automated Impella Controller (AIC) problem that may prevent the detection of an Impella pump when connected to an AIC. The pump detection problem may occur with any of the Abiomed Impella pumps and may occur during console-to-console transfer or at initiation of therapy at case start. There is no visual alarm displayed on the AIC screen to indicate the detection problem in these situations.
An occurrence rate of 0.02% was identified from complaints related to this problem. The risk of critical adverse consequences is considered low. However, if the AIC fails to recognise the pump, it may lead to life-threatening conditions and possibly permanent impairment.
The manufacturer is working to identify a permanent solution. |
| Instructions for Customers/Users |
The manufacturer is working to identify a permanent solution to the detection problem and a further update will be communicated to all affected customers.
Meanwhile, customers are to read the customer letter and to:
- Be aware hospital inventory may continue to be used.
- Prepare a back-up AIC as indicated in IFU, in the unlikely event of a device failure
- Recognise the frozen screen mentioned and be able to apply solution to the problems. |
| Action Commencement Date |
1/07/2025 |
| Responsible Entity |
|
| Contact Information |
0424 960 142 – David Fletcher, Abiomed Australia |