HVAD Injury, Death Reports Long Before Recall Draw Questions from Congressional Oversight Subcommittee

An investigation has been launched by U.S. law makers into the FDA’s approval of a Medtronic heart device, which was removed from the market following thousands of Heartware Ventricular Assist Device (HVAD) injury and death reports.

U.S. Representative Raja Krishnamoorthi, chairman of the House Subcommittee on Economic and Consumer Policy, sent a letter (PDF) to Food and Drug Administration (FDA) Commissioner Robert Califf on March 22, calling for the agency to turn over information on its regulation of the Medtronic HVAD system, which was subject to a recall, and then total market removal, in June 2021.

The letter notes the system was linked to more than 20,000 patient injuries and 3,000 deaths before it was fully removed from the U.S. market.

The HeartWare Ventricular Assist Device (HVAD) by Medtronic first received premarket approval from the FDA in November 2012, with a design intended to help pump blood from the heart to the rest of the body among patients who are awaiting a heart-transplant and at risk of death from end-stage left ventricular heart failure. The system includes a pump implanted in the space around the heart, with a controller that regulates the speed and function of the pump.

Benefits of the devices included the ability to be used in either a hospital setting or during patient transport. However, over the course of the last decade, Medtronic issued more than a dozen recalls involving component defects and malfunctions, ranging from startup failure to the company needing to update instructions for use and patient manuals.

Krishnamoorthi’s letter notes that the FDA was aware of problems with Medtronic HVAD injuries and deaths dating back to 2014, seven years before it was pulled from the market. The agency even sent Medtronic a warning letter in June 2014, indicating the HVAD was adulterated because it failed to comply with federal standards, and had already been linked to at least two deaths and 27 complaints.

“FDA failed to seized devices, stop Heartware from selling them, or assess monetary penalties against HeartWare after the 2014 violations and despite continuing violations,” the letter states. “A 2018 inspection showed seven separate violations. Three of them had appeared in FDA’s 2014 Warning Letter, but were still unresolved years later. Even then, the agency did not penalize the manufacturer.”

The Medtronic HVAD system was linked to more Class I recalls than any other high-risk medical devices. The class I designation for 15 such recalls indicates the FDA believed problems with the Medtronic HVAD system in each of those instances put patients at risk of severe injury and death.

When the devices were finally recalled permanently, Medtronic had admitted it could not identify the root cause of rampant device failure and restart issues which had contributed to more than a dozen deaths, and ceased all distribution of the devices.

The letter asks Califf to explain why the FDA failed to take further action after the 2014 warning letter, what steps the agency is taking to prevent another faulty medical device from entering and staying on the market and what it can do to ensure other agencies and healthcare providers are aware of FDA warning letters.

Krishnamoorthi asked for a response from the agency by April 5.