Medical devices bring hope and health to millions of Americans and to people around the world. However, using such a device comes with some risks, especially if improperly designed or manufactured. Manufacturers have a legal duty to warn consumers as well as medical professionals about any injury risks that are associated with these devices. The Food and Drug Administration (FDA) also plays a role in preventing injury or death by warning consumers about potential harm.
Medtronic has ordered a recall of a heart device called the HeartWare Heart Ventricular Assist Device or HVAD. The device showed disturbing signs of failure early after its introduction to the medical market.
Did the FDA let consumers down?
The FDA reportedly knew about many of the problems associated with the HVAD. As far back as 2014, the agency issued recall notices regarding the HVAD. The reasons for these recalls include:
- Pump failure due to electrostatic discharges
- Faulty battery, adapter and data cables
- Disconnections between the power and the pump controller
- Delay or failure restarting the device
The FDA reportedly received more than 100 complaints about the device. However, the agency never penalized the company before its recall. Unfortunately, the HVAD was also the cause of at least 14 patient deaths. Thousands of patients had the device implanted despite the FDA’s knowledge about the problems with it.
If you have suffered an injury or lost a loved one because of the HVAD, you may have grounds to file a products liability claim and obtain financial compensation for your harm. Experienced legal guidance can help you seek that compensation.