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Amara View Amara View Mask Without Headgear, Medium, USRecalls & reported problems

Respironics, Inc. · Amara View Mask without Headgear, USA, Medium · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959009233), received between Oct 27, 2022 and Nov 22, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 2026.

Most reported problems

Device problems

  • Patient Device Interaction Problem1
  • Patient-Device Incompatibility1

Patient problems

  • Failure of Implant2
  • Reaction to Medicinal Component of Device1

Recent adverse event reports

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

  • InjuryNov 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    THE MANUFACTURER BECAME AWARE OF A VOLUNTARY MEDWATCH REPORT (MW5112944) BEING FILED IN REGARDS TO ALLEGATIONS THAT HER AMARA VIEW FULL FACE MASK WITH MAGNETS CAUSED HER DENTAL BRIDGE (IMPLANTED IN 1997) TO NEED TO BE REMOVED. USER NOW NEEDS A BONE GRAFT AND DENTAL IMPLANTS FOR 5 TEETH IN THE FRONT OF HER MOUTH. THE USER STATES HER DENTAL INSURANCE DOES NOT COVER IT. USER STATES SHE HAS USED THIS MASK FOR APPROXIMATELY FIVE YEARS. NO MASK WILL BE RETURNING FOR INVESTIGATION. THIS WILL BE REPORTED AS AN INITIAL FINAL. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Patient problems: Failure of Implant

    MAUDE report 15844078 ↗
  • InjuryOct 27, 2022Patient-Device Incompatibility

    I HAD A DENTAL BRIDGE THAT HAD TO BE REMOVED. IT CONTAINED METAL AND I USED THE AMARA FULL FACE MASK EVERY NIGHT FOR APPROXIMATELY 5 YEARS. I AM NOW HAVING TO GET BONE GRAFTS AND DENTAL IMPLANTS FOR 5 TEETH IN THE FRONT OF MY MOUTH. IT IS GOING TO COST ME APPROXIMATELY (B)(6) AND MY DENTAL INSURANCE DOES NOT COVER IT. FDA SAFETY REPORT ID (B)(4).

    Patient problems: Failure of Implant; Reaction to Medicinal Component of Device

    MAUDE report 15690704 ↗

Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices

All VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices →

Sources and updates

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