From April 2021 to Oct. 31, 2022, Philips Respironics has reported 260 deaths to the FDA as part of its recall of 3.5 million ventilators after a foam breakdown was pushing black debris into inhalation tubes.
Philips Respironics pulled the products off the market in June 2021, and after about a year, 169 deaths were reported with a possible tie to the recall. Between Aug. 1 and Oct. 31 this year, that number has risen to 260 — a 54 percent increase — according to a Nov. 22 safety communication update.
In the reworked BiPAP and CPAP machines from Philips Respironics, there have been additional issues, including the foam breaking off from the device's plastic backing and traces of particulate matter, which have been sent to third-party labs for testing.