On December 2, 2019, Abbott provided an Urgent Medical Device Recall notice to customers regarding inference of static electricity with the HeartMate Mobile Power Unit™ when used with HeartMate 3™ Left Ventricular Assist System.
Urgent Medical Device Recall: HeartMate 3 Outflow Graft Leak (C-Ring) – 30 March 2019
On March 30, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating reports of the HeartMate 3 Outflow Graft leaking at its pump connection during implantation because the Screw Ring either disconnected or did not tighten completely.
On March 7, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a physician observed a small black plastic particle in the left ventricle during the implant procedure after using the HeartMate 3 Coring Tool. Investigation into this issue has confirmed that the particle came from the Coring Tool’s plastic blade cover.
On October 17, 2018, Abbott provided an update to physicians on the previously communicated Class I Recall associated with the HeartMate 3 Left Ventricular Assist System. Abbott has received FDA approval for the Outflow Graft Clip, designed to prevent any rotation of the outflow graft, thus addressing the safety concern reported in the May 2018 notice.
HeartMate 3 Left Ventricular Assist System Outflow Graft Twist External FAQ – 24 May 2018
On May 22, 2018, FDA classified this medical device advisory as a Class I Recall. Abbott provided a Frequently Asked Questions document for physician use as needed, to cover the most common questions relating to the HeartMate 3 Left Ventricular Assist System recall.
On May 21, 2018, Abbott provided an update to the Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.
On April 5, 2018, Abbott provided an Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.
MAT-2012391 v1.0
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Precautions
Please be sure to read it.
The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
Are you a healthcare professional?
Test
