The agency claims the number of replacement and remediated CPAPs and other respiratory devices shipped to U.S. consumers is considerably less than the 2.46 million number of “new replacement devices and repair kits” posted on Philips’ website.
The FDA said: “The 2,460,000 number includes manufactured repair kits that Philips shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers. We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device. We encourage consumers to contact Philips to get an update on the status of their replacement device.”
In a statement shared with MassDevice, Philips said it is looking into how to best address the FDA’s concerns. “To date, we have been reporting on the total amount of new replacement devices and repair kits that have been produced and shipped to the country of destination. This means that not all of these devices are already in the hands of patients. To date, approximately 2.2 million devices have been remediated in the U.S.”
More about the Philips recall
In mid-2021, Philips kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could potentially degrade and get into a patient’s airway.
Fast forward nearly two years, and Philips Respironics is still effectively out of the respiratory devices market as it works to repair the devices. FDA presently has nearly 100,000 reports of problems, including 346 mentioning deaths. (It’s important to note that FDA’s Medical Device Reporting system is a passive system with limitations.)
Philips CEO Roy Jakobs has said the Dutch medtech giant is deeply sorry about the recall.
The Dutch medtech giant remains in consent decree talks with the U.S. Department of Justice and the FDA.
