FDA Releases New Recommendations for Medtronic HVAD System Implants

FDA Releases New Recommendations for Medtronic HVAD System Implants

The FDA has updated its recommendations for individuals with Medtronic HeartWare Ventricular Assist Device (HVAD) System implants. Patients have faced frightening uncertainties due to life-threatening malfunctions linked to HVAD systems. The Medtronic device has spurred multiple recalls out of concern for the lives and health of patients. While the FDA has advised individuals against removing the heart failure device, the agency has created a guideline for patients stuck with the Medtronic implant. We will break down the FDA’s new directions for patients implanted with the Medtronic HVAD device. 

Medtronic Has Launched Numerous Device Recalls

The medical device company Medtronic has been a leading force in healthcare technologies and therapies for decades. Yet, the company has rolled out a number of recalls in the past few years to address several product defects. Notable Medtronic recalls in 2021 include the Medtronic MiniMed Insulin Pump and the Valiant Navion Thoracic Stent Graft System. 

Among the major Medtronic recalls in 2021 was the Medtronic HeartWare Ventricular Assist Device system. The company ceased distribution and sales of the device after receiving over 100 complaints involving injury, implant removal, and death. However, this June 2021 announcement was one of many concerning the HVAD system. Between 2014 and 2021, the Medtronic HVAD device underwent fifteen company-initiated recalls. In 2021 alone, Medtronic issued three separate recalls for differing reasons for the HVAD system. 

Deaths and Injuries Associated With Medtronic HeartWare Ventricular Assist Device System

The Medtronic heart pump device debuted in 2012, and by 2022, the FDA had received 20,000 reports of injury and 3,000 accounts of deaths. Pump failures, delayed restarts, faulty batteries, and welding defects have increased the risk of neurological adverse events and mortality for patients. A faulty HVAD system can lead to stroke, neurological dysfunctions, sepsis, and worsening heart failure symptoms. 

Patient Recommendations for Recalled Medtronic Heart Pump Device 

Once Medtronic finally stopped distributing the HVAD system in 2021, thousands of patients had already received the devices. An estimated 4,000 people worldwide still have the heart pump devices implanted today. Despite the health hazards, the FDA does not advise patients to remove the device without a medically necessary reason. The agency believes the risks associated with removing the implant outweigh the benefits. Therefore, the agency has outlined recommendations for healthcare professionals and patients. The FDA’s directions for patients are as follows: 

  • Always follow manual instructions
  • Keep your VAD coordinator informed of any concerns with your device, no matter how small
  • Always have two power sources connected to the controller
  • Always have spare batteries and a backup controller 
  • Never disconnect both power sources for charging 
  • If a Power Disconnect alarm sounds while a battery is connected to your device, replace the battery as soon as possible and do not use the battery again, and then notify your VAD coordinator
  • Check your controller for dirt and grime weekly 
  • Contact your coordinator to inform of any high or medium-priority alarms or alarms that you cannot resolve, or that stopped too quickly
  • Contact your coordinator for replacement components 

The FDA’s Advice for Healthcare Providers 

Per the FDA, HVAD patients should maintain regular communication with the VAD coordinator. The FDA also offered recommendations for healthcare providers. Healthcare providers should follow all instructions in Medtronic’s notification letters and manual. Also, the agency noted medical professionals should remind patients of the above recommendations and regularly inspect the device for any damage or wear. 

Finally, the FDA encouraged patients and healthcare providers to report any adverse events or suspected events experienced with the Medtronic HVAD System.