Philips recall sparks 48K complaints to FDA in 3 months, including 44 deaths

In only a little over a year, the FDA has racked up more than 69,000 complaints linked to Philips’ recall of millions of its breathing support devices—after receiving only 30 such reports in the entire decade preceding the start of the recall in June 2021.

The bulk of those post-recall complaints flooded in within the last three months, the agency said in an update this week to its safety notice about the recall. According to the FDA, between May 1 and July 31, it received more than 48,000 medical device reports linked to the respiratory device issues, including 44 reports of death.

That influx of reports comes shortly after the FDA in March issued an order forcing Philips to immediately notify all affected users, suppliers, distributors and retailers of the devices about the recall. At the time, the agency said, "the company’s notification efforts to date have been inadequate." Meanwhile, recent months have also seen the list of class-action lawsuits against the devicemaker stretch to include more than 300 separate actions, per an August 15 count (PDF).

In contrast, in the year between April 2021—when Philips first alerted the FDA to its then-upcoming safety event—and April 2022, the regulator tallied around 21,000 device reports. That cache of complaints included 124 deaths linked to the recall.

Altogether, the issues with Philips’ CPAP machines, ventilators and other respiratory devices have been linked to 168 deaths and many more injuries including cancer, pneumonia, asthma, infection, headache, dizziness, chest pain and more. None of the 30 reports sent in the decade prior to the recall included details of patient injuries or deaths.

The recall and related medical device reports stem from issues with the polyester-based polyurethane foam used to muffle sound and vibrations in many of Philips’ breathing support machines. Over time, the foam has been found to break down, potentially sending foam particles and possibly harmful chemicals into a user’s airstream.

In the year or so since the recall began, Philips has progressively expanded it to include all devices containing the foam that were manufactured between 2009 and the end of April 2021—totaling around 5.5 million machines distributed across the globe.

Users can register their affected devices with the company’s ongoing repair-and-replace program. As of late July, Philips said it had produced 3 million replacement devices and repair kits and reported that it was pushing the estimated end date for the program a few months back, to early 2023.

As the Dutch devicemaker begins to focus on the light at the end of the recall tunnel, it’s also plotting its financial recovery. Though the company estimated that the recall shaved off about 719 million euros from its bottom line in 2021 alone, in its latest earnings report at the end of July, Philips predicted that its beleaguered Respironics division will return to its prerecall, prepandemic financial status by 2025.

That rocky road to recovery will have a new captain at the helm: Philips announced this week that it plans to replace longtime CEO Frans van Houten with Roy Jakobs, who’s been heading up the company’s response to the recall. If approved in an upcoming shareholders meeting, the swap will take effect on October 15.