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# Pro Publica Slams FDA on Respirator Recall
- URL: https://www.fdaweb.com/pro-publica-slams-fda-on-respirator-recall/
- Published: 2023-12-07T12:00:00.000Z
- Updated: 2026-09-14T14:17:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155948

A lengthy, deeply-researched article released by the investigative newsroom ProPublica and the Pittsburgh *Post-Gazette* faults FDA for failing to use its power to protect millions of people who were using tainted Philips Respironics CPAP machines and ventilators. While FDA maintains that it acted as soon as it learned of the safety concerns in 4/2021, ProPublica [says](https://www.propublica.org/article/how-the-fda-failed-to-protect-millions-of-people-tainted-breathing-machines?ref=fdaweb.com) it found that “over the course of a decade, the agency missed a pattern of warnings from healthcare workers, patients, and others that something was very wrong with the company’s popular sleep apnea devices and ventilators.”

The report says that between 2011 and 2021 Philips sent hundreds of complaints about the machines to FDA, none of which led to alerts to doctors or patients. It questions whether anyone at FDA reads adverse event reports that are submitted.

After Philips recalled the devices in 2021, FDA said the company had withheld thousands of additional complaints, compromising the agency’s safety warning system. “FDA allowed the company to submit reports years later, so far without penalty,” ProPublica says. “FDA also permitted Philips to submit follow-up reports about those late complaints and update the dates that the company first received them. Then the agency concealed the original dates from the public, obscuring how long Philips had the warnings in hand before turning them over to the government.”

Former Justice Department prosecutor **Paul Pelletier** told ProPublica, “That’s regulatory failure. There is no other way to say it. They dropped the ball.”

The article says agency lapses in medical device enforcement have gone beyond Philips to other companies. “In analyzing complaints in the government’s tracking system, the news organizations found that other leading device makers have submitted hundreds of thousands of late reports to FDA, in some cases waiting years before disclosing the information,” the article says. “Last year alone, one in eight reports, more than 232,000 complaints, were submitted past the 30-day deadline, leaving regulators and the public without badly needed safety information. FDA has sent Warning Letters to errant companies, but criminal charges are rare.”

ProPublica says its analysis also exposed a troubling use of an FDA directive instructing manufacturers to update the dates they became aware of potential defects when providing follow-up reports to the agency.

“A review of more than 100,000 complaints submitted since 2013 by two dozen large medical device makers showed that dates were changed on one in five reports,” it says, “including those about flawed pacemakers, prosthetics, dialysis machines, and even screws and plates for bones.” ProPublica says an FDA statement acknowledged that device makers are directed to replace original dates when updating reports in the system, but said copies of earlier versions, which are not available in the public tracking system, are kept separately at the agency. It says FDA did not respond to questions about why such a policy is in place, but said that the tracking system is “just one source of information” about faulty medical devices.

The report says FDA defended its handling of the Philips recall, saying officials “continue to protect the health and safety of individuals using these devices.”

In a statement, Philips said it turned over the late breathing machine complaints to FDA “out of an abundance of caution” and that it did not initially believe that the complaints needed to be reported to the government.

Philips has said it is in discussions with FDA about a potential consent decree that could compel it to make significant improvements. FDA said it could not comment on possible enforcement action.

The report is critical of CDER director **Jeffrey Shuren**’s management of device failures. Although he told Congress FDA would “remain vigilant,” it says, the agency’s use of enforcement tools such as inspections and seizures has dropped significantly in recent years, even as the number of devices coming to market approached record levels.

In 2016, ProPublica reports, FDA awarded $3 million in seed money to the Medical Device Innovation Consortium (MDIC) to establish the National Evaluation System for health Technology (NEST) to bring together information from electronic medical records, insurance claims, and medical registries. Over eight years, it says, FDA devoted millions of dollars to the effort, but no comprehensive new system has emerged. The report notes that Shuren has been an MDIC board member for years.

FDA responded that Shuren adheres to all ethics and conflict of interest guidelines. ProPublica says he declined to be interviewed for the story and would not respond to written questions.