| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00125-1 |
| Product Name/Description |
Heartmate 3 LVAS Kits with Heartmate 3 Outflow Grafts & Heartmate II LVAS Kits with Heartmate II Outflow Grafts
Multiple model numbers
ARTG 293807
(Abbott Medical Australia Pty Ltd - HeartMate 3 Sealed Outflow Graft with Bend Relief - Implantable ventricular circulatory assist system outflow cannula, animal-derived)
ARTG 300895
(Abbott Medical Australia Pty Ltd - HeartMate 3 LVAS Implant Kit Model 106524INT - Implantable ventricular circulatory assist system)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has observed complaints related to a phenomenon known as “Extrinsic Outflow Graft Obstruction” (EOGO) associated with Left Ventricular Assist Devices (LVADs), including the HeartMate 3 Left Ventricular Assist System (LVAS).
EOGO is an outflow graft deformation accompanied by the presence of biologic material (biodebris) observed between the HeartMate 3 Outflow Graft and the Outflow Graft Bend relief or a non-HeartMate 3 component (such as a Gore-Tex/PTFE conduit or wrap added by the surgeon during implant).
The outflow graft deformation and substantial accumulation of biodebris under the bend relief can develop over years of support (usually 2 or more years).
This can obstruct blood flow through the pump which may interfere with hemodynamic support and manifest as a persistent low flow alarm.
If not treated, the obstruction may result in hemodynamic compromise, the need for surgical intervention, including possible pump replacement, and risk of death. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Abbott will update the Instructions for Use (IFU) to include additional diagnostic recommendations related to persistent low flow and related risks associated with EOGO by Q3, 2024.
Abbott is planning to implement design solutions to minimise the accumulation of biodebris on the outflow graft.
In the meantime, clinicians must continue to pay attention to low flow alarms as this is the first symptom of significant outflow obstruction.
If the patient’s signs or symptoms persist, it is important to rule out compression of the outflow graft through imaging such as a CT Angiogram. |
| Contact Information |
Nicole Tognetti - 0418 497 668 |