| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00602-1 |
| Product Name/Description |
HeartMate 3 LVAS Kit and Systems Controller
HeartMate 3 LVAS Kit
Model number: 106524INT
HeartMate 3 System Controller
Model number: 106531INT
HeartMate 3 System Low Flow Controller
Model number: 106531LF2
ARTG's: 300895, 443219, 289763, 443220, 345788 & 452547 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Abbott is notifying customers of a potential problem identified with the HeartMate 3 System Controller (Model 106531INT, 106531LF2) which is provided within the HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit (Model 106524INT) or distributed separately. These controllers were distributed after March 2024.
Abbott has identified that there is a potential for the controllers to have a lifted User Interface (UI) membrane that when present, is observed along the edge of the controller housing, near the Display Button.
If the UI membrane is lifted and if the controller were to be exposed to fluid, there is a potential for fluid ingress into the controller which may lead to damaged Printed Circuit Board Assemblies (PCBA). |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Customers should:
· Carefully inspect the controller at the edge near the Display Button to confirm that the UI membrane is not lifted prior to using the controller or providing the controller to patients.
· Report controllers with lifted UI membrane to Abbott Technical Support at 1-800-456-1477 or their local Abbott Representative.
· Explain this problem to patients and reinforce the need to follow the instructions in the Patient Handbook (PHB)
· Reinforce requirement to patient to perform the daily Self-Test to verify the display works appropriately as listed in “Performing a System Controller Self-Test” of the IFU, and pages 42-43 of the PHB.
· Reinforce “General Warning” and “Warnings and Cautions” within the IFU and the PHB to protect the controller from exposure to fluids and keep it always dry.
· In addition, patients who are permitted to shower, must use the Shower Bag for every shower. |
| Contact Information |
0418497668 - Nicole Tognetti |