Medical Device Vulnerability Disclosure

FDA Issues Update on the Philips BiPAP and CPAP Recalls

October 11, 2023 - Last week, the United States Food and Drug Administration released a statement updating consumers and industry leaders on the Philips Respironics recalls due to the potential risks associated with polyester-based polyurethane (PE-PUR) foam. The FDA Center for Devices and Radiological Health (CDRH) issued the update and attributed it to the director,...

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FDA Identifies Class I Recall on Philips CPAP and BiPAP Machines

by Veronica Salib

On April 7, 2023, the FDA identified a Class I recall on the Philips Respironics CPAP and BiPAP machines due to inaccurate or insufficient therapy. The devices, intended for treating sleep apnea, had a...

FDA Announces Malfunctions in Abbott’s MitraClip Device

by Veronica Salib

Mitral regurgitation typically requires a heart valve repair or replacement. Abbott’s MitraClip Clip Delivery System was approved by the FDA in 2013 as a heart valve repair device. However, on...

FDA Recalls Philips BiPAP and CPAP Machine Masks

by Veronica Salib

On September 6, 2022, the FDA shared that Philips recalled specific Philips Respironics masks for BiPAP and CPAP machines. The FDA’s news release shares that these devices have magnets in them,...

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