Infant Flow™ 777002MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752151956), received between Jan 10, 2022 and Aug 13, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NEONATAL RESUSCITATION TEAM HAS BEEN EXPERIENCING DIFFICULTIES USING THE INFANTFLOW NASAL MASK SIZE M COLOUR BLUE (REF:777002M). THE MASK BECOMES DEFORMED BY THE HUMIDITY IN THE INCUBATOR AND FLATTENS, CAUSING LEAKS AND BREATHING DIFFICULTIES FOR BABIES, LEADING IN SOME CASES TO MALAISE. THE MASK MUST BE CHANGED SEVERAL TIMES A DAY TO AVOID THIS PROBLEM. THE PROBLEM IS OBSERVED WITH ALL BATCHES OF SIZE M, WHEREAS IT RARELY OCCURS WITH MASKS OF OTHER SIZES (777002XS, 777002S, 777002L, 777002XL). NO PATIENT HARM WAS REPORTED. ONCE MASK WAS CHANGED, PATIENT BECAME STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978270 ↗
• InjuryJul 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A 26-DAY PREMATURE NEWBORN (27 SA) RECEIVING NON-INVASIVE VENTILATION WITH CONTINUOUS POSITIVE NASAL PRESSURE ON INFLANT FLOW (VARIABLE-FLOW NASAL GENERATOR), ALTERNATING M AND L MASK SIZES TO VARY PRESSURE POINTS. AFTER 3 HOURS WEARING A SIZE M MASK, THE BABY SHOWED A VERY MARKED DEPRESSION AT THE BOTTOM OF THE COLUMELLA. THE SKIN REMAINS SUNKEN DESPITE MASSAGE, AND IS SLIGHTLY BLACKENED. THE DEVICE WAS NOT KEPT FOR ANALYSIS. NO SERIOUS INJURY REPORTED, HOWEVER THERE IS A RISK OF BEDSORES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651736 ↗
• InjuryNov 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH INFANT FLOW LP NASAL MASK IN WHICH THE MASK AND PRONG KINKED, PREVENTING THE BABY FROM BREATHING. ATTEMPTS WERE MADE BY TIGHTENING OR LOOSENING SIDES, BIGGER AND SMALLER MASKS, BUT DID NOT HELP. FURTHERMORE, THERE WAS NOT PATIENT HARM REPORTED. THE PATIENT WAS TAKEN OFF CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) AND PUT ON THE HEATED MUSTACHE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074468 ↗
• InjuryJan 10, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MASK CONTINUALLY ROLLED UNDER AND COLLAPSED ON BOTH PATIENT'S FACES DESPITE FREQUENT REPOSITIONING WHICH CAUSED POOR SEAL FOR CPAP COMPROMISING RESPIRATORY STATUS AND CAUSED UPPER LIP IRRITATION AND REDNESS. THEY SWITCHED TO NASAL PRONGS SINCE THE MASK WAS NOT EFFECTIVE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. 6 TESTS/LAB DATA.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13214463 ↗