HeartWare Heart Pump Problems Were Known, But Dangerous Implants Continued: Report

Thousands of individuals throughout the United States have received HeartWare heart pumps, despite known manufacturing and quality control problems with the implants that may pose serious health risks, according to a recent investigative report.

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 individuals who are awaiting a heart-transplant and face a potential 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 are supposed to include use in either a hospital setting or during patient transport. However, over the last decade, Medtronic has issued at least 13 HVAD recalls involving component defects and malfunctions, ranging from startup failure to the company needing to update instructions for use and patient manuals.

The independent newsroom ProPublica published an investigative journalism report into the heart pump problems this month, indicating that both Medtronic and the FDA have done little to dissuade the widespread use of the HeartWare implants, even after rampant problems were reported by doctors and patients, and manufacturing issues were identified by regulators.

The Medtronic HVAD systems have been plagued by problems in recent years, and the manufacturer announced that it was removing the HeartWare heart pumps from the market entirely in June 2021, amid a growing number of adverse neurological events and patient deaths.

After the Medtronic HeartWare HVAD market removal was announced, the U.S. Food and Drug Administration (FDA) instructed healthcare providers to no longer implant end-stage heart failure patients, due to a risk of pump failures. However, the ProPublic report suggests that the move should have come much earlier.

According to ProPublica, FDA inspectors began voicing concerns 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 lays 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.

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

HeartWare HVAD Problems

HeartWare devices have a long history of manufacturing and design defects and have been the subject of numerous recalls. In April, the FDA announced a Medtronic Heartware HVAD recall, indicating the controller and power cabling may be prone to unexpected failure and cause the devices to stop functioning.

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 power failure 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.