Amara View Amara View Mask with Headgear, Large, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959009219), received between Jan 21, 2022 and Jul 9, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Biocompatibility; Biocompatibility

  THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT WITH ALLEGATION OF CHEST PAIN WHILE USING HIS AMARA VIEW MASK MAGNET. PATIENT STATED WHILE HE WAS ASLEEP, HE STARTED HAVING CHEST PAIN, WITH HIS NECK ON HIS SHOULDERS. THE PATIENT DID NOT SEEK MEDICAL INTERVENTION THE NEXT DAY, BUT HAD PRIOR TO, AND THE DOCTOR STATED THE MASK MAGNETS HAD INTERFERE WITH HIS STINTS. THE PATIENT ALLEGES THAT HE IS SLUGGISH AND TIRED BECAUSE OF THE CHEST PAIN. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Angina

  MAUDE report 22460382 ↗
• MalfunctionAug 31, 2022No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE MANUFACTURER WAS NOTIFIED BY AN END USER THAT THE MAGNETS IN THE HEADGEAR WERE CAUSING PRESSURE AND BLEEDING ON HER MOLARS. SHE REPORTED ONE OF THE TEETH HAD A GOLD METAL CAP. THERE WAS NO REPORT OF SERIOUS OR PERMANENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. NO PRODUCT WAS RETURNED. THE USER WAS ADVISED TO SPEAK TO HER PROVIDER OR DENTIST. THIS MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THE USER IS WARNED, "CONSULT A PHYSICIAN OR DENTIST IF YOU ENCOUNTER TOOTH, GUM, OR JAW SORENESS. USE OF A MASK MAY AGGRAVATE AN EXISTING DENTAL CONDITION." BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: Pain

  MAUDE report 15328934 ↗
• InjuryJan 21, 2022Positioning Problem; Positioning Problem

  A VOLUNTARY MEDWATCH WAS RECEIVED BY THE MANUFACTURER WITH THE USER ALLEGING AN ABSCESS SECONDARY TO ROOT DEATH THAT REQUIRED ROOT CANAL SURGERY. THE USER STATES REPOSITIONING OF HER AMARA VIEW MASK CAUSED CONSTANT PRESSURE ON THE INCISOR ROOT AREA WHICH CAUSED TOOTH INJURY LEADING TO THE ROOT CANAL. THE USER HAS WORN THE SAME STYLE MASK FOR 5 YEARS. THE MANUFACTURER REQUESTED THE MASK FOR INVESTIGATION. THE INVESTIGATION IS ON-GOING. A FOLLOW UP FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: Abscess; Pain

  MAUDE report 13313891 ↗