AuraGain 408400000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05707480129577), received between Jul 10, 2025 and Jun 24, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Inadequacy of Device Shape and/or Size

  TRAUMATIC INJURY WITH MASK REMOVAL. DURING SEVERAL USES OF THE MASK, THE PATIENT HAD INJURIES WITH BLEEDING WHEN THE MASK WAS REMOVED. ONE PATIENT HAD A CUT ON THE TONGUE FRENULUM AND A HEMATOMA, WHICH REQUIRED AN ENT CHECK. THE MASK WAS USED CORRECTLY BY TRAINED MEDICAL STAFF. THE ISSUE HAS BEEN REPORTED TO QUALITY FOR FOLLOW-UP AND ANALYSIS. PATIENT OUTCOME: UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25612369 ↗
• InjuryJun 24, 2026Inadequacy of Device Shape and/or Size

  TRAUMATIC INJURY WITH MASK REMOVAL. DURING SEVERAL USES OF THE MASK, THE PATIENT HAD INJURIES WITH BLEEDING WHEN THE MASK WAS REMOVED. ONE PATIENT HAD A CUT ON THE TONGUE FRENULUM AND A HEMATOMA, WHICH REQUIRED AN ENT CHECK. THE MASK WAS USED CORRECTLY BY TRAINED MEDICAL STAFF. THE ISSUE HAS BEEN REPORTED TO QUALITY FOR FOLLOW-UP AND ANALYSIS. PATIENT OUTCOME: UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25604313 ↗
• InjuryJul 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE CUSTOMER REPORTED THAT PATIENT HAD SENSORY DEFICIT OF THE TIP OF THE TONGUE AFTER GA EXAM. THE DEFICIT WAS STILL PERSISTING 7 DAYS AFTER THE PROCEDURE.

  Patient problems: Hyporesponsive to stimuli; Nerve Damage

  MAUDE report 22472588 ↗
• InjuryJul 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE CUSTOMER REPORTED THAT PATIENT HAD SENSORY DEFICIT OF THE TIP OF THE TONGUE AFTER GENERAL ANESTHESIA (GA) EXAM. THE DEFICIT WAS STILL PERSISTING 7 DAYS AFTER THE PROCEDURE.

  Patient problems: Hyporesponsive to stimuli; Nerve Damage

  MAUDE report 22466848 ↗