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# House Panel Grills FDA on Medtronic Heart Pump
- URL: https://www.fdaweb.com/house-panel-grills-fda-on-medtronic-heart-pump/
- Published: 2022-03-25T12:00:00.000Z
- Updated: 2026-09-14T17:38:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151457

The House Oversight and Reform committee is seeking answers to what FDA regulatory enforcement actions have been sought against Medtronic’s troubled HeartWare Ventricular Assist Device (HVAD) System — a heart pump device associated with more than 20,000 patient injuries and 3,000 deaths before it was recalled 6/2021 ([see earlier story](https://www.fdaweb.com/stop-implanting-medtronic-hvad-system-fda/)).

“This long overdue recall arrived too late for too many, including the 2,000 U.S. patients who still have the heart device implanted,” said Subcommittee on Economic and Consumer Policy chairman **Raja Krishnamoorthi** in a [3/22 letter](https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2022-03-22.RK%20to%20Califf-FDA%20re%20HVAD%20System.pdf?ref=fdaweb.com) to FDA commissioner **Robert Califf**. “I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs.” The letter notes a 2014 Warning Letter after its factory inspection revealed that the device was adulterated.

Krishnamoorthi’s letter said it was troubling that FDA failed to seize devices, stop HeartWare from selling them, or assess monetary penalties against HeartWare after the 2014 violations and despite continuing violations. “A 2018 inspection showed seven separate violations. Three of them had appeared in FDA’s 2014 Warning Letter, but were still unresolved years later,” it said. “FDA also knew the device was dangerous because it was subject to more Class I recalls than any other high-risk device in FDA’s database.”

The letters asks for answers to the following questions:

- What regulatory actions, if any, did FDA contemplate in the years after the 2014 Warning Letter, and why did the agency not believe further action was warranted?
- What steps, if any, is FDA taking to revise its protocols to ensure that other agencies responsible for patient care are directly notified of agency Warning Letters and other critical device defects?
- What steps, if any, is FDA taking to revise its protocols to ensure that doctors and patients are directly notified of agency Warning Letters and other critical device defects?