Amara View Amara View Mask with Headgear, LargeRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959009158), received between Apr 13, 2021 and Nov 10, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT A USER OF THE AMARA VIEW FULL FACE MASK WITH HEADGEAR MAGNETS WAS EXPERIENCING PAIN IN HIS NECK WHERE HIS METALLIC DISC AND JOINT IMPLANT IS LOCATED. AFTER RECEIVING THE SAFETY NOTICE 2022-CC-SRC-001, THE USER STOPPED USING THIS MASK WITH HEADGEAR AND THE PAIN DISAPPEARED. THE USER WAS THEN DIAGNOSED WITH CANCER AND HIS DOCTOR DOES NOT EXCLUDE THE POSSIBILITY THAT BOTH THE PAIN AND CANCER DIAGNOSIS COULD BE RELATED TO THE USE OF THE MASK. THE MANUFACTURER HAS REQUESTED THE MASK TO BE RETURNED FOR INVESTIGATION. TO DATE, NO MASK HAS BEEN RETURNED. THE INVESTIGATION IS ON-GOING. A FOLLOW UP FINAL WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: Implant Pain

  MAUDE report 15774181 ↗
• InjuryApr 13, 2021Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN AMARA MASK CAUSED A PATIENT TO HAVE A CEREBROSPINAL FLUID LEAK DUE TO THE MASK PUSHING ON HIS NASAL BONE. THE PATIENT REQUIRED SURGERY IN RESPONSE TO THE ALLEGED EVENT. THE MANUFACTURER HAS REQUESTED THE RETURN OF THE MASK FOR EVALUATION, BUT THE DEVICE HAS NOT YET BEEN RECEIVED. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 11657269 ↗