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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-01527-1
Product Name/Description HeartMate 3 Left Ventricular Assist System and Outflow Graft Clip

HeartMate 3 Left Ventricular Assist System
Catalogue Number: 106524INT LVAS KIT, HM3

Outflow Graft Clip
Catalogue Number: 10012390GBL

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 4/12/2018
Responsible Entity Abbott Medical Australia Pty Ltd
Reason/Issue Further to the May 2018 Hazard Alert communication (RC-2018-RN-00668-1) sent to surgeons in regards to HeartMate 3 (HM3) Outflow Graft twist occlusions, Abbott is now informing physicians that the new Outflow Graft Clip will be available upon local regulatory approval.

The regulatory review of the design improvement is ongoing and Abbott expects to receive CE approval for the Outflow Graft Clip within the coming weeks.

The Outflow Graft Clip has been designed to prevent any rotation of the outflow graft, thus eliminating the safety concern reported in the May 2018 notice. The Outflow Graft Clip is intended to be used with all new patient implants and may be used on patient cases where an Outflow Graft twist is confirmed and surgical intervention is required.
Recall Action Hazard Alert
Recall Action Instructions 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. To avoid damaging the assembly, do not use tools to tighten the screw ring.
• Once the screw ring is tightened, apply the Outflow Graft Clip according to the Instructions For Use, as provided.

Ongoing Patients
• For patients not experiencing any evidence of an outflow graft obstruction, Abbott recommends standard of follow-up as previously outlined in the May 2018 notice without performing a surgical intervention to apply the Outflow Graft Clip.
• For patients previously implanted with the HM3 who are experiencing an outflow graft obstruction and require a surgical intervention to repair the obstruction, Abbott recommends applying the clip at the time of surgical intervention according to the Outflow Graft Instructions for Use.

This action has been closed out on 11/07/2019
Contact Information 1800 839 259 - Abbott MCS Clinical Specialist