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 Abbott Laboratories' Thoratec unit and distributed from July 2012 until last March. The ventricular assist device 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.

Up Next:


  • Popular

  • Recent

WATCH FOX 7 NEWS LIVE

FOX 7 News streams at the following times (all times Central):


Monday - Friday

4:30 a.m. - 10 a.m.

12 p.m. - 12:30 p.m.

5 p.m. - 6 p.m.

9 p.m. - 10:30 p.m.

Saturday

6 a.m. - 8 a.m.

6 p.m. to 6:30 p.m.

9 p.m. to 10 p.m.

Sunday

6 a.m. - 8 a.m.

5 p.m. to 5:30 p.m.

9 p.m. to 10 p.m.



Schedule subject to change in the event of network sports coverage.

We also stream press conferences and other breaking news coverage from time to time. When we are not in a live newscast, you will see replays of the most recent broadcast.

To enter full screen Mode click the button.

For closed captioning, click on the button while in full screen mode.

Desktop/tablet users: To choose the stream's video quality, click on the button (while in full screen mode) and choose from 432p or 270p.

Mobile users:The video quality default is to your phone's settings.

Please allow time for buffering. If the stream stalls, refresh your browser. Thanks for watching

Stories You May Be Interested In - Includes Advertiser Stories