Rep. Raja Krishnamoorthi, Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter to the Food and Drug Administration (FDA) requesting information about its regulation of the HeartWare Ventricular Assist Device (HVAD) System—a heart pump device associated with over 20,000 patient injuries and 3,000 deaths before it was recalled in June 2021. This long overdue recall arrived too late for too many, including 2,000 U.S. patients who still have the heart device implanted.
“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,” the Chairman 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.”
The HVAD System, which received FDA approval in November 2012, helped patients with heart failure pump blood to the rest of the body. The device was meant to be either a temporary aid for a patient awaiting a heart transplant or a permanent solution for a patient ineligible for a transplant. In 2014, FDA issued a Warning Letter after a factory inspection revealed that the device was non-compliant with federal manufacturing standards. Shockingly, this letter only requested that HeartWare take corrective actions, such as editing the patient manual and sending a letter to doctors, when FDA knew the device had been already been linked to 27 complaints, 4 injuries, and 2 deaths.
After issuing its 2014 Warning letter, FDA failed to use its authority to seize faulty HVAD devices, stop HeartWare from selling them, or assess monetary penalties against the company despite continuing violations. Between 2014 and 2021, the device underwent 15 company-initiated Class I recalls—more than any other high-risk device in FDA’s database. The entire HVAD System was eventually removed from the market in June 2021 because it was more likely to cause death and neurological adverse events than other devices on the market, and had caused at least 14 deaths.
Despite clear and life-threatening deficiencies with the device, the FDA never directly informed other federal agencies of the problems with the HVAD System before the device was recalled. As a result, the Centers for Medicare & Medicaid Services and the Department of Veterans Affairs spent millions of dollars to implant heart patients with a device FDA officials knew may not be safe.
In the letter, Chairman Krishnamoorthi requested that FDA provide information about why it did not take further action after the 2014 Warning Letter and what steps it has taken to revise its protocols to ensure that other federal agencies, patients, and doctors are notified of FDA Warning Letters.
Click here to read the letter to FDA.
Original source can be found here.
