Over 120 Deaths and 21,000 Complaints Accrue in Year after Philips’ Ventilator Foam Recall

May 23, 2022

Last April, Philips reported quality issues in the sound-reducing foam used in many respiratory aids, including ventilators, CPAP, and BiPAP machines. The US Food and Drug Administration (FDA) has just released a one-year update about the issue, finding that the deterioration of the foam resulted in over 20,000 complaints and 124 patient deaths. In addition, patients experienced side-effects and injuries ranging from cancer, asthma, infections, headaches, chest pain, and more.

According to Andrea Park of Fierce Biotech, “Though undoubtedly a serious indicator of the many potential risks of the sound abatement foam’s deterioration, the FDA noted that not all 21,000 MDRs are definitively linked to the issue, citing ‘under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event and lack of information about frequency of device use.’”

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