| TGA Action ID |
RC-2025-RN-01031-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Impella 5.5 Set with SmartAssist
Product Code: 1000482
Serial Numbers: 621454, 621455 |
| ARTG Number |
440630 |
| Action Type |
Recall |
| Action Level |
Wholesale |
| Hazard Classification |
Class III |
| Reason for the Action |
Two specific serial numbers of Impella 5.5 with SmartAssist have been inadvertently packaged with an Impella CP with SmartAssist outer box top. The correct Impella 5.5 Set with SmartAssist labels were applied to the product, however, the outer box top artwork does not represent the Impella 5.5 device. |
| Instructions for Customers/Users |
The two affected serial numbers are present with the distributor.
The distributor is advised to not further distribute these sets, and return the affected products to Abiomed. |
| Action Commencement Date |
4/12/2025 |
| Responsible Entity |
|
| Contact Information |
Dfletch1@its.jnj.com – David Fletcher, Abiomed Australia |