Reasons the HeartWare HVAD System was Recalled

Reasons the HeartWare HVAD System was Recalled

Medicines and medical devices are subject to recall by the United States Food and Drug Administration or even manufacturers if there exist significant problems to the public. When a medical device, for example, is released to the market it is intended to improve health. Should it cause death or injuries more times than not to users, recalls are likely to follow.

The HeartWare HVAD System was recently recalled by the FDA because of potential:

  • Neurological issues.
  • Death.
  • Malfunctioning could impact the ability of the heart to function.

Even Medtronic, the company that distributes the machine, issued its own response about the negative implications of using it. Medtronic has urged that healthcare providers using the units stop because of the poor health outcomes that could result to patients.

The HeartWare Ventricular Assist Device was designed to help the heart pump blood effectively all through the body. People that are in need of such a device are those that are:

  • At high risk of end-stage heart failure.
  • Require heart tissue recovery.
  • Trying to avoid having to have a heart transplant.

Why was the HVAD System Recalled?

Reasons the HeartWare HVAD System was RecalledThere were two very important reasons why this product had such strong recall including:

  • Patients using the pump were experiencing high rates of neurological issues.
  • Patients using the pump were having high rates of death.
  • The pump was not working properly and would just stop which affected the heart’s ability to function.

Nothing about the above issues is good for patients relying on these devices to support their heart’s functioning. If the pump can not sustain a patient’s heart to continue to beat, that patient’s life is in peril. Likewise, neurological issues are also bad. 

Patients using the device have reported that they suffered:

  • Stroke.
  • Increasing heart weakening and failure.
  • Heart attack.
  • Further hospitalizations. 
  • Needed further treatment.

The company was issued more than 100 complaints from users for the pump’s unreliability and inability to restart the heart. As a result, 14 people who used the product died.

It was advised that medical professionals who were using the device stop. Warnings were issued from the FDA and the manufacturer about the risks that came with using the device and that they were far worse than the benefits that could be ascertained.

There are certainly plenty of people that suffered harm and the threat of deadly injury using the HeartWave HVAD System. If you were one of these individuals living in or near the greater Jackson area, call Germany Law Firm, PLLC. 

The experienced and dedicated Jackson medical defective device attorney at Germany Law Firm, PLLC can help you navigate your options for obtaining fair compensation for your harm.

Speak with a Jackson Defective Medical Device Attorney Today

Consultations are always free. There is nothing to lose by taking your case to a qualified Jackson defective medical device lawyer. Call Germany Law Firm, PLLC today to schedule a free consultation at (601) 487-05558.

Issues concerning the heart are serious. If you have problems with your heart but were harmed by the medical equipment that you were prescribed, call the defective medical equipment attorney in Jackson for support and for help obtaining compensation.