Designed for use both in and out of hospital settings, including during patient transport, the HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump.
READ MORE Defective Medical Devices LEGAL NEWS
A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health effects including death.
The affected devices were manufactured between September 30, 2014 and February 29, 2016. A total of 4,564 units were identified in the FDA’s recall notice.
The FDA recall identifies the affected HeartWare controllers with product codes 1403, 1407,1400 and 1401.
The company said it notified patients with devices on June 8, instructing them about safe use of the device and to inspect for loose connectors.
READER COMMENTS
Mike Trimble
on
that by having to retire in 2012 restitution is due for the 7 years above as well as the stress of every day being concerned about the extra wire in my chest. Please review & advise., If you no longer deal with this let me know and I will seek legal recourse elsewhere, as I am very serious about this matter as time goes on! Thank You Richard Michael Trimble 09/7/19