Infant Flow™ 7772020LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10190752156531), received between Jan 6, 2023 and Jul 17, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO VYAIRE MEDICAL THAT SKIN INTEGRITY OF INNER ASPECT NOSTRILS WAS DAMAGED FOLLOWING USE OF DEVICE. MODERATE ERYTHEMA AT INNER ASPECT OF NOSTRILS WAS REPORTED.

  Patient problems: Erythema

  MAUDE report 19763720 ↗
• InjuryJul 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO VYAIRE MEDICAL THAT SKIN INTEGRITY OF NASAL SEPTUM DAMAGED FOLLOWING USE OF DEVICE. MODERATE ERYTHEMA AT BASE OF NASAL SEPTUM WAS REPORTED.

  Patient problems: Erythema

  MAUDE report 19763706 ↗
• InjuryJul 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SKIN INTEGRITY OF THE NASAL SEPTUM WAS DAMAGED FOLLOWING USE OF DEVICE. PATIENT HARM WAS REPORTED: SKIN INTEGRITY OF NASAL SEPTUM BROKEN, ERYTHEMA PAIN, INFECTION REQUIRING ANTIBIOTIC THERAPY.

  Patient problems: Erythema

  MAUDE report 19763347 ↗
• InjuryOct 10, 2023Partial Blockage; Material Integrity Problem; Partial Blockage; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 7772020LP PACKAGE ASSEMBLY, INFANT FLOW, LP HAS EXCESSIVE RAIN DISCHARGE THAT FORMS WITHIN THE EXHAUST LIMB AND POOLS AT THE PATIENT INTERFACE, SIGNIFICANTLY IRRITATING NEONATAL PATIENTS AND POSING A SERIOUS RISK OF WATER ENTERING THE PATIENT'S AIRWAY. FURTHERMORE, THERE IS NO INFORMATION REGARDING PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905700 ↗
• InjuryAug 30, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 7772020LP PACKAGE ASSEMBLY,INFANT FLOW,LP PLASTIC ASSEMBLY OF GENERATOR BROKE APART INTO 2 PIECES. IT WAS IN USE ON A PREMATURE BABY AND THE BABY'S VENTILATION WAS INTERRUPTED AND A NEW GENERATOR HAD TO BE CONNECTED TO FABIAN VENTILATOR AND ATTACHED TO HEADGEAR. WHICH RESULTED IN UNNECESSARY DISCOMFORT, BREATHING DIFFICULTY AND STRESS.

  Patient problems: Distress

  MAUDE report 17657780 ↗
• InjuryAug 11, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 7772020LP PACKAGE ASSEMBLY, INFANT FLOW, LP CAME APART WHILE CONNECTED TO A PATIENT. THEY HAD TO CHANGE THE WHOLE SET AS A RESULT. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17506914 ↗
• InjuryJan 6, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE USE OF THE 7772020LP - PACKAGE ASSEMBLY, INFANT FLOW, LP NASAL PRONGS FOR CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) RESULTED IN PRESSURE WOUNDS/RED MARKS ON THE PATIENT'S NOSE. ISSUE WAS QUICKLY IDENTIFIED, AND THE PRONGS WERE REPLACED BY A FACE MASK, AND THE REDDENED AREAS AT NARES EVENTUALLY IMPROVED. IT WAS STATED THAT THE NASAL PRONGS ARE NOT AS SOFT AS THE ONES FROM THEIR PREVIOUS SUPPLIER.

  Patient problems: Skin Discoloration; Skin Erosion

  MAUDE report 16114023 ↗
• InjuryJan 6, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE USE OF THE 7772020LP - PACKAGE ASSEMBLY,INFANT FLOW,LP NASAL PRONGS FOR CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) RESULTED IN PRESSURE WOUNDS/RED MARKS ON THE PATIENT'S NOSE. ISSUE WAS QUICKLY IDENTIFIED, AND THE PRONGS WERE REPLACED BY A FACE MASK, AND THE REDDENED AREAS AT NARES EVENTUALLY IMPROVED. IT WAS STATED THAT THE NASAL PRONGS ARE NOT AS SOFT AS THE ONES FROM THEIR PREVIOUS SUPPLIER.

  Patient problems: Skin Discoloration; Skin Erosion

  MAUDE report 16112737 ↗