| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00668-1 |
| Product Name/Description |
HeartMate 3 Left Ventricular Assist System
Catalogue Number: 106524INT LVAS KIT, HM3
ARTG Number: 300895
(Abbott Medical Australia - 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 |
1/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Further to the April 2018 Safety Alert communication (RC-2018-RN-00302-1) sent to surgeons in regards to HeartMate 3 (HM3) Outflow Graft twist occlusions, Abbott have identified the need for further clarification on the origin of the Outflow Graft twist, the persistent low flow alarm, additional recommendations for patient management and future mitigations to be implemented.
Abbott is aware that accumulation of an Outflow Graft twist may occur at any point post-implantation, which can reduce or stop pump flow. Occlusion of the HM3 Outflow Graft often requires urgent surgical intervention. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Abbott is investigating mitigations to prevent Outflow Graft twist occlusion. In the interim, Abbott recommends:
Existing Patients:
- Surgeons should refer to the information provided in the Customer Letter for managing patients who have been implanted with HM3
New Patients:
- During implant, when attaching the Outflow Graft to the Pump Cover, a clicking sound will be heard as the Screw Ring is tightened. Continue turning the Screw Ring clockwise until it comes to a complete stop and stops clicking. Firmly hand-tightening the Screw Ring may reduce the risk of Outflow Graft twisting by increasing the resistance to metallic Outflow Graft connector rotation. To avoid damaging the Outflow Graft assembly, do not use tools to tighten the screw ring.
- The proposed clarification on Warning and additional Caution statement will be incorporated into the Instructions for Use
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 839 259 - Abbott Customer Service |