The FDA has received reports of 44 more deaths associated with Philips Respironics’ massive respiratory device recall.
FDA’s update, posted yesterday, brings the death total to 168, with 69,000 medical device reports (MDRs) filed related to the recall.
The news comes amid Philips’ announcement that CEO Frans van Houten and the company’s supervisory board agreed that it is time for a change in leadership. The board unanimously decided to propose to promote Roy Jakobs, the company’s Connected Care chief businesses leader, to succeed van Houten, effective Oct. 15.
Jakobs took responsibility in June 2021 to address the Respironics recall on behalf of the company.
How serious is the Philips Respironics recall?
Last year, Amsterdam-based Philips (NYSE:PHG) Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. The recall is due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.
The company also stopped taking orders of sleep therapy systems as it handled the Class I recall. Philips has now been out of the respirator devices market for more than a year.
In March of this year, the FDA told Philips that its notification efforts on the recall of its ventilators had been inadequate to that point. A month later, the company revealed a Department of Justice subpoena for information related to the recall. The subpoena sought “information related to events leading to the Respironics recall.” Philips said its subsidiaries are cooperating with investigators.
On May 2, the FDA’s Center for Devices and Radiological Health (CDRH) proposed an order for Philips to submit a plan for the repair, replacement or refund of the purchase price of the recalled devices. The order would cover devices manufactured after November 2015.
An acceleration in reports about Philips devices
Philips only submitted 30 MDRs associated with the PE-PUR foam breakdown, with eight of those coming from the U.S, between 2011 and April 2021. In that pre-recall period, there were no reports of patient injury or death.
But in May, the FDA confirmed that it received more than 21,000 medical device reports (MDRs), including 124 reports of death, between April 2021 and April 30, 2022.
The FDA’s latest update includes data from the period that followed the first time frame, with more than 48,000 MDRs and 44 reports of death between May 1 and July 31 of this year.
“The FDA’s in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports during this time,” the FDA notice said. “The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.”