Medtronic HVAD Systems Carry Pump Malfunction Risk, FDA Warns

Federal regulators have identified yet another problem with Medtronic HVADs (HeartWare Ventricular Assist Devices), which have been plagued by recalls and safety concerns in recent years, and also now appear to be responsible for a number of patient deaths due to internal pump malfunctions.

The Medtronic HVAD system was first introduced in 2012, to help pump blood from the heart to the rest of the body among individuals awaiting a heart transplant, who are 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, a number of Medtronic HVAD recalls and issues have been identified over the past few years, including component defects and malfunctions, ranging from startup failure to the need for updated instructions to reduce risks for patients.

Last summer, the FDA announced Medtronic was removing its HVAD systems from the market, due to an unreasonable risk of neurological events and increased death rates among patients. However, many individuals still had the device implanted, and the FDA did not recommend that they have the Medtronic HVAD removed at the time, if there were no problems detected.

On April 28, the agency sent a new letter to healthcare providers, warning that the Medtronic HVAD internal pump may have a welding defect, which could lead to malfunctions and cause patients to suffer a pump thrombosis. At least two patient deaths have been linked to this newly reported problem.

The FDA warning comes after Medtronic issued an Urgent Medical Device Correction letter (PDF) to customers earlier this month, warning that it had received three complaints, including the two patient deaths, linked to pump thrombosis. An analysis of the devices found all three were malfunctioning due to a weld defect which allowed moisture into the devices and corroded magnets keeping an impeller rotating concentrically.

The FDA is recommending patients presenting with signs or symptoms of pump thrombosis be treated for that first, and if symptoms do not resolve, then health care professionals should consider where the patient should receive a new pump, a heart transplant, or just have the pump removed, based on the patient’s clinical condition and the risks of undergoing surgery.

The agency is still not recommending elective removal of properly functioning Medtronic HVAD systems and is still directing doctors not to implant new ones into patients.

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.

Many have questioned why the problematic devices remained on the market for so long.

Medtronic HVAD Problems

According to an August 2021 investigation by ProPublica, FDA inspectors began voicing concerns about Medtronic HVAD systems as early as January 2014, following a HeartWare recall in late December 2013, which was issued because the device could fail and stop pumping, leading to serious injury and death.

FDA investigators issued a warning letter a month later, after identifying a number of deficiencies at the HeartWare manufacturing facility in Miami Lakes, Florida, particularly involving the process for making sure that some corrections made to the HVAD actually work.

The ProPublica investigation lay the blame at the FDA’s feet, saying the agency allowed more than 19,000 patients to be implanted with the heart pump, most of whom received their implants after the FDA had determined the HeartWare HVAD did not meet federal safety standards.

When the devices were removed from the market in June 2021, the FDA indicated it had received more than 3,000 reports of patient deaths by the end of 2020, all linked to HeartWare implant problems.

Concerns about the devices have led to concerns among U.S. lawmakers as well. U.S. Representative Raja Krishnamoorthi, chairman of the House Subcommittee on Economic and Consumer Policy, sent a letter to FDA Commissioner Robert Califf on March 22, calling for the agency to turn over information on its regulation of the Medtronic HVAD system.

The letter asked 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. He asked for a response by early April. It is unclear to date whether the FDA has responded to that request.