The FDA announced today that it has received more than 90,000 reports of problems — including 260 mentioning deaths — in Philips’ massive respiratory devices recall.
It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations. Still, today’s update from the FDA is but another reminder of the seriousness of the Philips recall. The previous update in late summer listed 69,000 MDR entries since April 2021, including 168 reports of death.
New Philips CEO Roy Jakobs publicly apologized for the Philips Respironics recalls last month. The recalls involve 5.5 million CPAP and BiPAP ventilators and other respiratory devices.
In addition to consent decree talks with the DOJ and FDA, Philips also faces lawsuits.
The recall involves potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway. The particles could cause a range of potential health problems and toxic, carcinogenic effects for the user.
The company recently announced that it has produced roughly 4 million replacement devices and repair kits for the sound abatement foam recall. Philips Respironics said at the time that the goal is to complete about 90% of the production and shipments to customers this year.
However, the Dutch medtech giant is facing additional problems. For example, it recently reported two new potential issues with some reworked Philips Respironics Trilogy ventilators, about 3% of the devices in the original recall. There’s new silicone sound abatement foam that could separate from the plastic backing. Plus, the company reported trace amounts of particulate matter in the air pathway of some corrected ventilators in the U.S.