Medtronic HVAD Pump Implant Kit Recall Issued Over Weld Defect

The FDA has announced yet another Class I medical device recall for Medtronic HeartWare Ventricular Assist Device (HVAD) Systems, this time due to a defect that may cause the cardiac pumps to malfunction, increasing the risk of serious injury or death.

The Medtronic HVAD recall was announced by the agency on June 8, following at least three reports of a pump weld defect that resulted in two patient injuries and one fatality.

Medtronic actually removed the HVAD devices from the market in June 2021, due to numerous design problems, but some are still in circulation.

The HeartWare Ventricular Assist Device (HVAD) is designed to help pump blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure. These patients use the pump while waiting for a heart transplant.

The system includes a pump implanted in the space around the heart and a controller regulating the speed and function of the pump. It is designed to be used either in a hospital setting or during patient transport.

According to the recall notice, Medtronic has become aware of at least two injuries and one fatality related to a pump weld defect, which can allow moisture to enter the center post of the pump, causing corrosion and demagnetization of the internal magnets. Officials warn moisture penetration may cause the pump to rotate incorrectly, resulting in pump thrombosis.

The FDA and Medtronic are alerting healthcare professionals and patients that pump thrombosis could lead to a pump malfunction, death, severe organ dysfunction, stroke, or require patients to undergo major surgery to replace the pump.

The recall includes approximately 1,614 HVAD Pump Implant Kit with model numbers  1101, 1103, 1104, 1104JP, MCS1705PU that were sold to hospital and healthcare facilities across the U.S. from October 11, 2006 through June 3, 2021.

Medtronic sent an Urgent Medical Device Correction letter on April 11, instructing physicians to make decisions about removing or exchanging the pump on a case-by-case basis, taking the patient’s medical condition and surgical risks into consideration. Medtronic is requesting all unused kits be returned immediately and to submit all .csv logfiles to Medtronic when patients present symptoms from pump thrombosis.

Customers with questions regarding the recall are being asked to contact their local Medtronic Representative or contact Medtronic Patient Services at 800-35-3930.

Medtronic HVAD Problems

HeartWare devices have a long history of problems and have been subject to numerous Class I recalls due to serious and dangerous manufacturing and design defects that have caused thousands of patient fatalities.

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.