AF541 AF541 Mask, EE, Leak 1 with Capstrap, MediumRecalls & reported problems
Respironics, Inc. · AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Medium · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959024496), received between Feb 11, 2022 and Feb 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2022Obstruction of Flow; Obstruction of Flow
THE MANUFACTURER WAS MADE AWARE OF AN EVENT THAT OCCURRED WHILE A PATIENT WAS BEING PLACED ON NIV THERAPY. THE USER ALLEGED THAT THE AF541 EE MASK VALVE ALLOWING A CONTROLLED LEAK DID NOT FUNCTION PROPERLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS EVENT AND A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13515449 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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