In 2021, medical devicemaker Philips recalled 3.5 million ventilation devices after finding a defect that could cause cancer.
Now, more than 500 deaths have been linked to the devices recalled less than three years ago. Here is a timeline of Philips' recall saga:
1. In 2021, Philips recalled 3.5 million BiPAP, CPAP and mechanical ventilator devices. The devices used polyester-based polyurethane sound abatement foam, which has the potential to degrade into particles that could be ingested or inhaled and have toxic and carcinogenic effects.
2. In April, Philips faced another recall, recalling 1,088 reworked CPAP and BiPAP machines used for sleep apnea due to the potential for inaccurate or insufficient treatment.
3. In November, the FDA warned patients and healthcare providers to carefully monitor Philips machines used for obstructive sleep apnea after receiving reports that the machines have shown signs of overheating. The FDA believes the thermal issues reported may be linked to an electrical or mechanical malfunction, rather than the foam used in the machine, which was at the center of the June 2021 recall of an earlier version of the CPAP machine.
4. In January, the Government Accountability Office launched a probe into the FDA's oversight of medical device recalls, brought about in part by investigative reports alleging the FDA did not alert patients or physicians about issues with the breathing machines, despite having received hundreds of complaints in the years leading up to Philips' massive 2021 recall.
5. In late January, Philips agreed to stop selling sleep apnea devices under a consent decree agreement with the FDA.
6. In February, the FDA announced it has received more than 500 reports of death tied to Philips' recalled sleep apnea devices since 2021. More than 116,000 reports of harm tied to the devices have been shared with the FDA since April 2021, 561 of which involved deaths. Between July and September of 2023, the agency received 111 reports of death related to the machines.