| TGA Action ID |
RC-2026-RN-00576-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Automated Impella Controller (AIC)
Product Code(s): 0042-0000-AU, 0042-0000-UK, 0042-0010-AU, 0042-0040-AU
All lots and serial numbers are affected |
| ARTG Number |
288729 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Abiomed has identified an increase in complaints due to purge cassette recognition problems resulting from failures of the purge flag component within the purge pressure sensor assembly. The purge flag engages with the purge disc and allows the AIC to recognise that the purge disc is inserted properly.
These failures require an AIC exchange to solve the problem.
There have been reports of 37 serious injuries and 3 deaths associated with this problem. |
| Instructions for Customers/Users |
Hospital inventory can continue to be used to ensure continuity of care.
Abiomed is addressing these failures by replacing the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC. Abiomed’s field service team will contact customers to schedule the correction.
Customers are to:
- In the event of these purge flag component failures and associated alarms, as per Instructions for Use (IFU), first reinsert purge disc to address the alarm. If that action does not clear the alarm, switch to a backup AIC.
- Ensure cleaning of the AIC housing with mild detergent as specified in the IFU.
- Ensure routine preventive maintenance is performed annually on their AIC(s). |
| Action Commencement Date |
21/08/2026 |
| Responsible Entity |
|
| Contact Information |
jgong10@its.jnj.com, OneMD-Field-Actions@its.jnj.com - Abiomed Australia |