Story at a glance
- Global medical device company Phillips recalled its Bi-Level (PAP), CPAP, and other products in connection with health risks.
- Select devices with PE-PUR foam pose possible carcinogen exposure to the device user.
- Company officials cited few complaints but issued a recall as a precautionary measure.
Leading global medical device company Phillips issued a major recall Monday for several of its ventilator products amid reports of health risks associated with use of its devices.
Officials at the company emphasized that the recall was voluntary on behalf of the company and cited a low complaint rate of just 0.03 percent of customers in 2020. Phillips says it has produced of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam, a substance that could pose a risk.
Some of the possible health risks reported to Phillips included headaches, inflammation, respiratory issues and toxic and carcinogenic effects and other irritations.
The devices that are under recall are the Phillips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices featuring polyester-based polyurethane (PE-PUR) sound abatement foam.
No deaths have been reported in connection with the Phillips devices.
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” said CEO Frans van Houten. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices.”
Devices with the PE-PUR foam could disintegrate into particles which enter the device’s air pathway and be inhaled by the user, exposing the individual to possible harmful chemicals.
Both devices focus on treating sleep apnea.
The company noted in a 2021 quarter one earnings report that they identified a quality issue with select sleep apnea and respiratory products, stating that it was investigating the reports of faulty devices.
It’s sales growth for the beginning of 2021 came in at 9 percent, bolstered by growth in its Diagnosis & Treatment areas, as well as its Personal Health department.
Amid the recall of its apnea and ventilation products, Phillip’s stock tanked by 4.23 percent as of Monday morning.