Medtronic Warns of HVAD Battery Problems Result in Another Recall

Medtronic is again reporting problems with its beleaguered HeartWare Ventricular Assist Devices (HVAD), after discovering that a welding defect could result in a battery malfunctions and failure of the crucial heart devices, which has already been linked to one patient death.

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.

Last summer, the FDA announced the removal of Medtronic HVAD systems from the market, due to an unreasonable risk of neurological events and increased death rates among patients following numerous product recalls. 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.

This week, Medtronic issued an Urgent Medical Device Recall Notice (PDF) to customers, indicating that a new recall impacts a single lot of HVAD batteries, which were used in more than 400 devices.

According to the recall notice, the single lot of batteries has been linked to multiple instances of welding defects which could cause the battery to malfunction and no longer hold a charge, no longer completely recharge, or fail to provide power to the life-sustaining device.

“If a battery experiences this malfunction during use it will trigger a [Power Disconnect] alarm. This alarm will be visible on the controller screen and in the Alarm Log tab of the HVAD Monitor,” the Medtronic letter warns. “Additionally, it may be accompanied by a [Critical Battery] alarm once battery power reaches 10%. The Battery Indicator Light on the controller will turn off once the battery power is fully depleted.”

While Medtronic HVAD battery problems that trigger the alarm may be temporarily resolved by recharging, this does not permanently solve the issue and loss of power issues may continue to occur, the manufacturer warns.

Medtronic indicates it has received two complaints involving three batteries and one patient death. The patient that died had a device where two batteries simultaneously malfunctioned and stopped sending power to the patient’s HVAD device.

The recall affects a single lot of HeartWare Ventricular Assist Device System batteries with model number 1650DE. Each individual battery has a serial number, and a full list of affected serial numbers is listed in Attachment A of the recall notice. An estimated 429 batteries are affected by the recall.

Medtronic is asking customers to immediately identify and quarantine the affected batteries and to immediately notify patients with affected batteries of the recall and then remove the batteries from service. The recall notice provides customers with instructions on returning the recalled HVAD batteries and having them replaced.

The recall comes just days after the FDA warned that the Medtronic HVAD internal pump may have a welding defect, which could lead to malfunctions and cause patients to suffer a pump thrombosis. Two patient deaths have been linked to the problem. However, 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.

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.