A congressional oversight subcommittee has opened an investigation into the FDA's regulation of the HeartWare Ventricular Assist Device, which was implanted into thousands of Americans after the agency identified safety issues with the heart pump, ProPublica reported March 23.
The investigation follows a ProPublica report from August 2021 that found the FDA first identified manufacturing issues with the device in 2011. The agency in 2014 issued a warning letter to the devicemaker, HeartWare — acquired by Medtronic in 2016 — after identifying more safety lapses with the device. The FDA relied on the companies to voluntarily address the issues, and never penalized them when they failed to correct issues by set deadlines.
The heart pump went on to be implanted in more than 19,000 patients, most of whom received it after the FDA was aware the device did not meet federal standards, according to ProPublica. By 2020, the agency had received more than 3,000 reports of patient deaths possibly linked to the faulty HeartWare device.
"I am concerned by the FDA's slow action, over multiple administrations, to protect patients from this product despite early warning signs," Rep. Raja Krishnamoorthi wrote in a letter to FDA commissioner Robert Califf, MD. In the letter cited by ProPublica, Mr. Krishnamoorthi requested information on how the agency made regulatory decisions related to the device and why it didn't take further action. Mr. Krishnamoorthi is the chair of the U.S. Committee on Oversight and Reform's Subcommittee on Economic and Consumer Policy, which is leading the investigation.
Mr. Krishnamoorthi set an April 5 deadline for the FDA to respond. In response to ProPublica's request for comment, the FDA said it would respond directly to Mr. Krishnamoorthi's letter. Medtronic declined to comment on the investigation.
Medtronic pulled the heart pump from the market in June 2021 after finding a competing device from Abbott produced better clinical outcomes.
In a statement sent to Becker's, an FDA spokesperson said the agency's decisions are made with "the health and safety of device users as our highest priority."
"The FDA has actively monitored the performance of Medtronic's HeartWare device since it was approved in 2012. The patients and providers who rely upon this life-sustaining device to treat advanced, end-stage heart failure have always been at the forefront of our decision making. In the last five years, the medical device landscape for patients with end-stage heart failure has evolved through the introduction of an alternative approved device, the Abbott HeartMate 3 Left Ventricular Assist System, which, in recent studies, has been shown to generally have an improved performance. The FDA is continuing to work with Medtronic to ensure that all deficiencies are resolved and with Abbott to ensure an adequate supply of HeartMate 3 devices are available for future patients," the statement said.
Editor's note: This story was updated March 25 at 12:45 CST to reflect the FDA's statement.