FDA: Controller for heart pump recalled over deaths

Federal regulators say nearly 29,000 controllers for implanted heart pumps are being recalled after reports of 26 deaths linked to malfunctions.

The recall covers the external power supply controller for the HeartMate II, made by Abbot's Thoratec unit and distributed from July 2012 until last March. The helps the heart's main pumping chamber circulate blood.

The Food and Drug Administration on Wednesday said 70 malfunctions have been reported, all after patients switched to a backup unit on their own. The FDA is warning users to only change the controller at a hospital.

The manufacturer recently notified customers about the recall and is giving patients new software and new controllers if needed.


Explore further

FDA OKs first compact heart-assist device

© 2017 The Associated Press. All rights reserved.

Citation: FDA: Controller for heart pump recalled over deaths (2017, May 24) retrieved 6 December 2019 from https://medicalxpress.com/news/2017-05-fda-heart-recalled-deaths.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
0 shares

Feedback to editors

User comments