3100A HFOV 29028-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 50190752155259), received between Jan 14, 2022 and Jan 26, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Too Soft/Flexible” (5 reports).

1 other recall cover devices cleared under the same FDA submission (P890057); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2024Disconnection; Disconnection

  IT WAS REPORTED TO THE VYAIRE MEDICAL THAT THERE IS "AN INTERMITTENT" ISSUE WITH THE BOXED PATIENT CIRCUIT ASSY, 3100A, 850L. OCCASIONALLY, THE TUBE FITTING ON THE INSPIRATORY HOSE CONNECTED TO THE NECK ON THE HUMIDIFIER IS LOOSE. THIS INTERRUPTED PATIENT VENTILATION ON TWO OCCASIONS. AFTER THE SECOND INTERRUPTION, TUBING WAS SECURED USING A CABLE TIE. 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 18588038 ↗
• MalfunctionJun 23, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  THE CUSTOMER REPORTED THAT THE BOXED PATIENT CIRCUIT ASSY, 3100A, 850L IS EXTREMELY PLIABLE AND BEND WHICH OBSTRUCTS THE FLOW ON THE OSCILLATOR AND OFTEN STOPS IT FROM WORKING. THE ISSUE IS OFTEN ASSOCIATED WITH THE TUBING THAT IS CONNECTED TO THE HUMIDIFIER. THE CUSTOMER STATED THAT THEY HAVE HAD 5 OF THE SAME ISSUE. THE OSCILLATOR TURNED OFF AND THEY TRIED TO RESTART IT BUT TO NO AVAIL. THEY CALLED IN A MEMBER OF THE STAFF WHO NOTICED THAT A PART WAS POPPED OFF BY THE HUMIDIFIER. THEY CALLED TECH TEAM, PUT THE TUBING BACK ON AND PLACED A TAPE OVER THE TUBING TO KEEP IT IN PLACE. THERE IS NO PATIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14795028 ↗
• MalfunctionJun 1, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  THE CUSTOMER REPORTED THAT THE 29028-004 BOXED PATIENT CIRCUIT ASSY, 3100A, 850L IS EXTREMELY PLIABLE/BENDY WHICH HAS IMPLICATIONS WITH THE FLOW ON THE OSCILLATOR AND OFTEN STOPS THE OSCILLATOR. IT IS OFTEN ASSOCIATED WITH THE TUBING THAT IS CONNECTED TO THE HUMIDIFIER. TUBING NEEDED TO BE PUT BACK ON/REPLACED AND SECURED WITH A TAPE. THERE IS NO INFORMATION ON PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566905 ↗
• InjuryJan 14, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 29028-004 DESCRIPTION BOXED PATIENT CIRCUIT ASSY, 3100A, 850L IS EXTREMELY PLIABLE AND BEND WHICH HAS IMPLICATIONS WITH FLOW ON THE OSCILLATOR AND OFTEN STOPS THE OSCILLATOR. LUNG DE-RECRUITMENT OCCURRED AS AN INTERVENTION, CIRCUIT WAS REPLACED WITH THE NEW ONE TO ENABLE OSCILLATION TO CONTINUE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13261993 ↗
• InjuryJan 14, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 29028-004 DESCRIPTION BOXED PATIENT CIRCUIT ASSY, 3100A, 850L IS EXTREMELY PLIABLE AND BEND WHICH HAS IMPLICATIONS WITH FLOW ON THE OSCILLATOR AND OFTEN STOPS THE OSCILLATOR. LUNG DE-RECRUITMENT OCCURRED AS AN INTERVENTION, CIRCUIT WAS REPLACED WITH THE NEW ONE TO ENABLE OSCILLATION TO CONTINUE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13261988 ↗
• InjuryJan 14, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 29028-004 DESCRIPTION BOXED PATIENT CIRCUIT ASSY, 3100A, 850L IS EXTREMELY PLIABLE AND BEND WHICH HAS IMPLICATIONS WITH FLOW ON THE OSCILLATOR AND OFTEN STOPS THE OSCILLATOR. LUNG DE-RECRUITMENT OCCURRED AS AN INTERVENTION, CIRCUIT WAS REPLACED WITH THE NEW ONE TO ENABLE OSCILLATION TO CONTINUE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13261981 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P890057. One submission often covers many models, so check the product and lot details in each record.

• Z-0488-2024 · Oct 27, 2023 · Completed
  vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)