FDA collects another 6,000 complaints—including 40 deaths—linked to Philips' CPAP recall

Despite recent test results showing that the disintegrating polyester-based polyurethane (PE-PUR) foam at the heart of Philips ongoing respiratory device recall “is unlikely to result in an appreciable harm to health in patients,” users of the affected CPAP and BiPAP machines and ventilators continue to file complaints—including reports of injuries and deaths—associated with the recall.

The FDA updated its tally of those medical device reports (MDRs) on Friday, adding more than 6,000 complaints from the first three months of this year to the roster. Forty included reports of patient deaths, though both the FDA and Philips have been quick to note that MDRs are unvetted complaints, and the injuries they detail may not have been directly caused by a recalled device.

Those new additions bring the total number of MDRs that the FDA has collected between April 2021—when Philips first began alerting customers to potential issues with some of its respiratory devices—and the end of March of this year to more than 105,000, with 385 reported deaths.

Philips had previously detailed the additions to the MDR tally in a late April update (PDF) on the ongoing recall. According to the company, 4,800 of the latest swath of complaints arrived in January and February, with the remaining 1,200 counted in March.

The devicemaker also doubled down on its denial that the injuries and deaths detailed in the reports are definitively caused by the foam breakdown.

“Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these MDRs,” the company wrote. “The vast majority (~94%) of the approximately 105,200 MDRs filed since April 2021 up to and including March 2023 are alleged malfunctions that do not involve reported serious injury or death.”

The FDA’s original Class I recall notice advised patients and healthcare providers that if the foam—which is used to muffle sounds and vibrations in many of Philips’ respiratory support machines—began to break down over time, it could send bits of debris and untested chemicals into a user’s airflow. Those particles, in turn, could potentially cause headaches, external and internal irritation, asthma, nausea and “toxic or carcinogenic effects to organs, such as kidneys and liver,” among other symptoms, per the agency.

Philips’ latest set of safety test results, however, which covered the CPAP and BiPAP sleep therapy machines that make up about 95% of the recalled devices, found that not only was there “low” foam degradation among the used devices researchers examined but also that when the foam does degrade, “exposure to particulates from degraded foam in these devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.”

Despite that disconnect, Philips has plowed ahead in its efforts to repair or replace all 5.5 million devices recalled around the world. As of early May, according to the company, it has produced more than 98% of the replacement devices and repair kits needed—though, as the FDA recently clarified, that doesn’t necessarily represent the number of devices and kits that have actually reached patients.