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Medtronic Heartware Ventricular Assist Device (HVAD) System

The Food and Drug Administration (FDA) has issued an alert to health care providers regarding Medtronic’s Heartware Ventricular Assist Device (HVAD) System. According to the alert, Medtronic has halted the sale of its HVAD System due to an increased risk of serious injury or death associated with the device. Health care providers are advised to discontinue implementation of the HVAD System in patients.

Medtronic HVAD System Lawyers are Ready to Help

Contact our Medtronic HVAD System Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Medtronic HVAD System cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Medtronic HVAD System Lawyers at our law firm, please call (800) 315-3806or submit an email inquiry.

What is Medtronic HVAD System?

The Medtronic HVAD System is used in patients with advanced left ventricular heart failure. It assists in pumping blood from each ventricle to the body through an external controller and battery pack connected to a cable through the skin. The HVAD System was originally approved for those awaiting cardiac transplants. It was subsequently authorized for long-term use in those who are not eligible for transplants.

What is Happening with Medtronic HVAD System?

The FDA announced that Medtronic has stopped the sale and distribution of its HVAD System as a result of an increase in reports of adverse neurological events and death compared with other comparable devices available to patients. The complaints are largely related to issues with restarting the pump. Following more than 100 incidents of defective HVAD internal pumps, Medtronic recommended that health care providers no longer use the implant. The FDA received reports of 14 deaths and 13 procedures to remove the faulty pump.

The HVAD system has been at the center of several recalls in the past for failure to start or a delay in restarting the pump after it fails. The FDA issued a Class I recall in March 2020 after receiving complaints of faulty restart of the HVAD System. In addition to those reports, Medtronic has now identified incidents of stroke and death in patients with the HVAD system, which prompted its most recent action.

https://www.medtronic.com/us-en/healthcare-professionals/products/cardiac-rhythm/ventricular-assist-devices/hvad-system/indications-safety-warnings.html

https://www.fda.gov/medical-devices/letters-health-care-providers/stop-new-implants-medtronic-hvad-system-letter-health-care-providers

https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-hvad-pump-implant-kits-due-delayed-or-failed-restart-after-pump-stopped

Medtronic HVAD System Side Effects and Complications

Complications of Medtronic HVAD System include :

  • Neurological dysfunction;
  • Stroke;
  • Bleeding;
  • Right ventricle failure;
  • Infection;
  • Sepsis; and
  • Death.

Medtronic HVAD System Lawyers are Ready to Help

Contact our Medtronic HVAD System Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Medtronic HVAD System cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Medtronic HVAD System Lawyers at our law firm, please call (800) 315-3806or submit an email inquiry.

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