The FDA has recalled Medtronic’s HeartWare HVAD System
The HeartWare Ventricular Assist Device (HVAD) System is a left-ventricular device that is primarily used to keep the heart pumping blood in patients who need cardiac transplants and who may die from end-stage left ventricular heart failure without such a device.
On June 3, 2021, The FDA announced the Class 1 recall of Medtronic’s left ventricular assist device known as The HeartWare HVAD System. A class 1 recall is “the most serious type of recall. Use of these devices may cause serious injuries or death.” As the FDA noted in its public announcement of the recall:
“Medtronic is stopping the distribution and sale of the Heartware HVAD System because:
- There is an increased risk of neurological adverse events and mortality associated with the internal pump.
- If the internal pump stops, it may delay restarting or fail to restart.
Both problems may lead to death or serious patient harm including stroke, heart attack, worsening heart failure, the need for additional procedures and hospitalizations.”
Ury & Moskow, LLC’s lawyers have been leaders in pursuing medical product liability lawsuits involving unsafe drugs and medical devices. Our attorneys have successfully brought about verdicts, settlements, awards, or other recoveries in lawsuits on behalf of clients who have been injured by Fen-Phen, Redux, Vioxx, Baycol, Ephedra, Rezulin, Propulsid, Gadolinium, Guidant ICDs, Hormone Replacement Therapy, Sulzer hip implants, Phenylpropanolamine (PPA), Trasylol, Pradaxa, DePuy Hips, Stryker Hips, Zyprexa, and many other drugs and medical devices.
The Pharmaceutical and Medical Device Liability Attorneys at Ury & Moskow are pursuing claims for personal injury and death resulting from the use of the HeartWare HVAD System against the manufacturer, Medtronic. Such cases and if necessary, lawsuits, are handled on a contingency fee basis. That means the client is never at risk of paying any money out of pocket. If there is no recovery, there is no fee. We file lawsuits in individual cases only after a thorough review of medical records and assessment of the facts in each case.
Our HeartWare HVAD System lawsuit lawyers represent victims nationwide in association with local firms we know and trust. We provide each client’s case with individualized attention and care. Remember, time limitations can bar late claims, so if you or a loved one has been injured by a HeartWare HVAD System, please contact our firm as soon as possible. We have a toll-free (no-cost) telephone number to reach an attorney to answer your questions with regard to your specific case. That number is 888-529-4335.
If you would prefer, please feel free to fill out the “Contact Us ” form on our website. Be sure to include your name, address, telephone number, e-mail address, and the exact nature of your question so that our lawyer can provide you with the specific information you seek.
HeartWare ® is a registered trademark of Medtronic, and is used here only to identify the product in question.
This law firm is not associated with, sponsored by, or affiliated with Medtronic.
Cases may be referred to another attorney or law firm.