Medtronic HeartWare Recall Given Most Serious Designation By FDA

Following a string of recalls and potentially thousands of patient deaths, Medtronic removed its Heartware implants from the market earlier this year, and the FDA has now classified that action as a Class I recall; which is the most serious designation that can be used.

The U.S. Food and Drug Administration (FDA) announced the Heartware Class I recall designation on August 12, following up previous instructions to healthcare providers to no longer use the implants on end-stage heart failure patients due to a risk of pump failures that could delay or prohibit life-saving therapies. The Class I designation means the FDA is now warning the problems with the devices are likely to cause severe injury or death.

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 last decade, Medtronic has issued at least 13 recalls involving component defects and malfunctions, ranging from startup failure to the company needing to update instructions for use and patient manuals.

The newly issued Class I recall designation follows Medtronic’s Heartware HVAD market removal announcement on June 3, in which the manufacturer instructed healthcare professionals to stop implanting the devices immediately after recent investigations could not pinpoint the root cause of a HVAD pump restart failure impacting approximately 4,630 devices.

In the market withdrawal notice, Medtronic announced it has decided to cease all manufacturing and distribution of the devices due to a growing number of adverse neurological events and increased mortality rates among patients.

The decision came after the latest recall in March, when Medtronic issued a Heartware pump failure recall following 100 complaints involving a delay or failure to restart the HVAD internal pump, which has caused a total of 14 deaths and 13 emergency pump removal surgeries.

In May 2020, Medtronic issued another HeartWare HVAD Class I recall following nearly 100 reports of problems where the strain relief screw broke and outflow graft tore while preparing the device for implant. The recall warned the design defect placed patients at risk of suffering serious injuries, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, and the need for additional medical procedures or death.

In June 2018, Medtronic issued a HeartWare HVAD recall impacting more than 16,000 units that had been implanted in patients as of May 22, 2020. The recall was initiated after Medtronic discovered the electrical connection between the system’s power source, such as the battery, AC adapter, or DC adapter, and the HVAD controller could be interrupted, potentially causing the pump to stop working, resulting in an exacerbation of heart failure symptoms, including weakness, dizziness, anxiety, nausea, loss of consciousness or death.

Last week, the independent newsroom ProPublica published an investigative journalism report into the heart pump problems, indicating that both Medtronic and the FDA have known of the device issues for nearly a decade, yet have done little to dissuade the widespread use of the HeartWare implants.

According to the report, the FDA had received more than 3,000 reports of patient deaths by the end of 2020, all linked to HeartWare implant problems.