| TGA Action ID |
RC-2026-RN-00350-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Apical Coring Knife (1050) part of the HeartMate 3 LVAS Kit
Model Number: 106524INT
Serial numbersNumbers: MLP-059464, MLP-059471, MLP-059472, MLP-059473, MLP-059474 |
| ARTG Number |
443219, 468565 |
| Action Type |
Product Correction / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
As of April 13, 2026 Abbott has received six (6) complaints reporting a concern in which the Apical Coring Knife Handle does not form the expected “T” configuration when inserted into the side holes of the Apical Coring Knife during surgical preparation.
This action applies to Apical Coring Knife Handles included in or distributed with HeartMate 3 LVAS Kits following a change implemented in September 2025.
There is potential for this problem to cause inconvenience or extended procedure times. |
| Instructions for Customers/Users |
Customers are to:
- Continue to assemble and use the device according to Instructions for use. If the handle appears uneven, the procedure may still be completed using clinical judgement, and no product return or replacement is required.
Abbott has corrected this problem with a change in the handle manufacturing process, and production of the Apical Coring Knife Handle with the corrected configuration resumed in May 2026. |
| Action Commencement Date |
14/05/2026 |
| Responsible Entity |
|
| Contact Information |
0423 603 654 - Tania Thomas |