| TGA Action ID |
RC-2026-RN-00115-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Automated Impella Controllers (AICs) with Software Version 8.5, used in conjunction with an Impella 5.5 S1
Product Codes: 0042-0040-AU
Impella 5.5S1 product code: 0550-0007 |
| ARTG Number |
288729 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Automated Impella Controllers (AICs) with software v8.5, when used in conjunction with an Impella 5.5 S1, have a delayed “Purge System Blocked” alarm.
Undetected high purge pressure may result in a complete pump stop, resulting in a loss of haemodynamic support. |
| Instructions for Customers/Users |
Customers are recommended not to use an Automated Impella Controller with an Impella 5.5 S1 unless the Automated Impella Controller software is updated to v10.1 or above.
Abiomed representatives will coordinate directly with hospitals to implement the required software update.
This action has been finalised on 10/7/2026. |
| Action Commencement Date |
16/02/2026 |
| Responsible Entity |
|
| Contact Information |
OneMD-Field-Actions@its.jnj.com, dfletch1@its.jnj.com – Abiomed Australia |