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The Philips Respironics PE-PUR foam recall, from the public record

By Kelsey research · Published

In June 2021 Philips Respironics recalled certain ventilators, BiPAP machines and CPAP machines because the polyester-based polyurethane (PE-PUR) foam used to reduce sound and vibration can break down. Below is the dated record from FDA and from Philips. Dates given only by month are shown that way, because the source gives no day.

Chronology, April 2021 to April 2024

Date Event Date type Source
Apr 2021 Philips notifies FDA of its intention to conduct a field action over PE-PUR foam breakdown in certain ventilators, BiPAP and CPAP machines. Philips's later press release refers to a company update on April 26, 2021. submitted [1][2]
Jun 2021 Philips formally submits its Report of Correction and Removal (an "806 report" under 21 CFR part 806). submitted [2]
Jun 14, 2021 Philips issues a recall notification in the U.S. It cites possible risks from foam particles and off-gassing, and says that "to date, there have been no reports of death as a result of these issues." announced [1]
Jun 30, 2021 FDA issues a safety communication on the recall. It lists affected models made between 2009 and April 26, 2021. It repeats that there were no reports of death to date and says it is analyzing medical device reports for 2009 to 2021. published [3]
Jul 2021 FDA identifies the recall as Class I, "the most serious type of recall." announced [2]
Aug to Nov 2021 FDA inspects Philips's facility in Murrysville, Pennsylvania. announced [2]
Jan 26, 2022 FDA publishes an update describing the recall of certain Trilogy EVO ventilators as Class I. A foam not intended for those ventilators, also PE-PUR, was used in certain units. FDA's page dates the update, not the classification itself. published [2]
Mar 10, 2022 FDA issues a notification order to Philips to notify device users, suppliers and clinicians. announced [2]
May 2, 2022 CDRH issues a notice proposing a section 518(b) order requiring a repair, replacement or refund plan. announced [2]
Oct 5, 2023 FDA's device center states it "remains unsatisfied with the status of this recall" and does not believe Philips's testing is adequate to evaluate the risks. announced [4]
Jan 29, 2024 FDA acknowledges Philips's announcement that it agreed on terms of a consent decree with the Department of Justice. announced [5]
Jan 31, 2024 FDA updates its count of device reports tied to the foam (see below). published [6]
Apr 9, 2024 A federal district court enters a consent decree against Philips Respironics. announced [7]

Class I, and how FDA and Philips described the risk

FDA's page explains that Class I recalls "involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death."[2] It gives July 2021 as the month of the classification and does not give a day. FDA states that the foam problems "could potentially result in serious injury and may require medical intervention to prevent permanent injury." It adds that breakdown "may result from exposure to hot and humid conditions and may be worsened by using ozone cleaners or other cleaning methods not recommended by the manufacturer."[8] Philips's June 2021 release says its complaint rate was 0.03% in 2020 and that it determined, based on testing, that there are "possible risks to users."[1]

Device reports, 30 before April 2021 and more than 116,000 after

FDA's reporting page says Philips submitted 30 device reports between 2011 and April 2021 that it identified as associated with foam breakdown. Eight were from the United States, and none described patient injury or death. It then says that since April 2021, FDA had received more than 116,000 reports, including 561 reports of death, "reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown." The page lists a wide range of reported injuries, including cancer, pneumonia, asthma, infection, headache and cough.[6]

FDA adds a limit on these numbers: the system cannot "typically" determine incidence, prevalence or cause, because of under-reporting, inaccuracies, and "lack of verification that the device caused the reported event."[6]

In October 2023, FDA wrote that Philips had concluded exposure to foam particles and volatile organic compounds was "unlikely to result in an appreciable harm to health in patients." FDA said additional testing was necessary, and Philips agreed to conduct it.[4] FDA's activity page also records that FDA initially approved Philips's plan to replace the foam with a silicone-based one based on testing from June 2021. Information obtained during the inspection led FDA to ask for independent laboratory testing of the silicone foam.[2]

The consent decree restricts, with limited exceptions, production and sale of new CPAP and BiPAP machines at several Philips Respironics facilities in Pennsylvania and California until stated requirements are met. It also requires a Recall Remediation Plan, with a new or remediated device or, for certain models, a partial refund.[7]

What the record shows, and what it leaves open

Philips notified FDA in April 2021 of its intention to conduct a field action, its public recall notification followed on June 14, 2021, and FDA identified the recall as Class I in July 2021. FDA moved from an alert, to an inspection and a notification order, to a proposed repair-or-refund order in 2022, and to a consent decree in 2024. FDA and Philips differ in how they assess the health risk. Philips concluded that harm was unlikely, and FDA said the testing shared to date was not adequate to fully evaluate the risks.

The record does not show that foam breakdown caused any particular injury or death. FDA's own statement says device reports cannot establish that. The June 2021 statements about no deaths reflect what had been reported then, and the later report counts are far larger than the 30 reports Philips identified before April 2021. The record does not show how many users were exposed to breakdown products. It does not give the results of the additional testing FDA requested after October 2023 (this page did not review Philips's published testing results). It also does not describe any individual claim. The consent decree is an enforcement outcome between the government and the company.

Sources

  1. Royal Philips, press release, "Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices," June 14, 2021. https://www.usa.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-care-devices.html
  2. FDA, FDA Activities Related to Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines. https://www.fda.gov/medical-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines/fda-activities-related-recalled-philips-ventilators-bipap-machines-and-cpap-machines
  3. FDA, Safety Communication, "Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks," date issued June 30, 2021 (archived copy). https://web.archive.org/web/20210701000000/https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks
  4. FDA, CDRH statement, "CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam," October 5, 2023. https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-provides-update-philips-june-2021-recall-and-maintains-recommendations-related-potential-health
  5. FDA, CDRH statement, "CDRH Statement on Philips' Announcement," January 29, 2024. https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-statement-philips-announcement
  6. FDA, Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines (update of January 31, 2024). https://www.fda.gov/medical-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines/problems-reported-recalled-philips-ventilators-bipap-machines-and-cpap-machines
  7. FDA, press release, "Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines," April 9, 2024. https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-philips-respironics-following-recall-certain-sleep
  8. FDA, Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines (page current as of 11/20/2024). https://www.fda.gov/medical-devices/respiratory-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines