Congress investigating FDA over heart device recall, says agency ‘failed to protect consumers’

Congress has opened an investigation into how the FDA handled the 2021 recall of Medtronic’s HeartWare Ventricular Assist Device (HVAD) system.

The recall, finalized on June 3, came after ongoing issues that resulted in 14 deaths and 13 pump removals. In fact, a recall of some HVAD implant kits was announced back in March 2021.

In an open letter to FDA Commissioner Robert Califf, MD—who has years of experience as a practicing cardiologist—Rep. Raja Krishnamoorthi said the recall “arrived too late for too many.”

Krishnamoorthi, who serves as chairman of the Subcommittee on Economic and Consumer Policy, also highlighted that the HVAD system was associated with “more than 20,000 patient injuries and 3,000 deaths” before it was recalled.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” he said.

Krishnamoorthi said the Subcommittee on Economic and Consumer Policy wants the FDA to provide more information about its actions by April 5.

“The FDA is charged with ensuring patient access to safe, effective, and high-quality medical devices, but, over multiple administrations, the agency failed to protect consumers from the dangerous HVAD System,” Krishnamoorthi wrote. “The agency likewise failed to adequately share knowledge of the device’s defects with other agencies. FDA must take a more proactive role in its regulation of devices that have been the subject of Warning Letters and Class I recalls, and in its communication of product defects to other agencies responsible for patient health.”