3100A HFOV 29028-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 50190752159820), received between Mar 16, 2022 and Jan 27, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Too Soft/Flexible” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Disconnection; Material Too Soft/Flexible; Disconnection; Material Too Soft/Flexible

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BOXED PATIENT CIRCUIT ASSY, 3100A, 850L IS BECOMING MALLEABLE AND LOOSE ONCE HEATED, ALLOWING THE DEVICE TO GET DISCONNECTED WHILE BEING USED BY A PATIENT. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253492 ↗
• MalfunctionOct 1, 2022Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE BOXED PATIENT CIRCUIT ASSY, 3100A, 850S BROKE APART. IT HAPPENED DURING SETUP, PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526088 ↗
• MalfunctionOct 1, 2022Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE BOXED PATIENT CIRCUIT ASSY, 3100A, 850S BROKE APART. IT HAPPENED DURING SETUP, PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526087 ↗
• InjuryJul 11, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  THE CUSTOMER REPORTED THAT THE PLASTIC IN WHICH THE BOXED PAT CIRCUIT ASSY, 3100A, FLTRD, 850L IS MADE FROM IS NOT SUFFICIENTLY RIGID FOR ITS PURPOSE. THEY HAVE A CHILD THAT IS BEING TREATED WITH THE 3100A FOR 2.5 DAYS, AND THE CIRCUIT/HOSE HAS A CABLE TIE IN PLACE TO MAKE IT LEAK TIGHT. THE CIRCUIT IS WARM, AND THE PLASTIC FEELS MUCH SOFTER THAT IT DID WHEN IT WAS SET UP, WHICH MAYBE THE REASON IT IS NOT GRIPPING THE CONNECTOR PROPERLY. NO HARM IS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978596 ↗
• InjuryJul 11, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  THE CUSTOMER REPORTED THAT THE PLASTIC IN WHICH THE BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L IS MADE FROM IS NOT SUFFICIENTLY RIGID FOR ITS PURPOSE. THEIR 3100A HAD A PATIENT WHICH WAS CUTTING OUT SUDDENLY AND NOT RESTARTING. UPON CHECKING, THE TUBE BETWEEN THE VENTILATOR AND THE HUMIDIFIER WAS BENT OVER, NOT ALLOWING GAS TO GET INTO THE CIRCUIT. END USER THEN REPOSITIONED THE HOSE AND TAPED IT TO THE SIDE OF THE 3100A FOR SUPPORT. NO HARM IS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978478 ↗
• InjuryJun 19, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT DURING VENTILATOR USE, THE END USER NOTICED A LEAK AND TRACED IT TO THE BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L. IT WAS ON THE INSPIRED SIDE AFTER THE HUMIDIFIER. IT WAS LOOSE ON THE CONNECTOR, ALLOWING GAS TO ESCAPE. END USER FIXED THE LEAK WITH A CABLE TIE, AND TREATMENT WAS NOT INTERRUPTED. NO HARM IS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741276 ↗
• InjuryMar 17, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L IS EXTREMELY PLIABLE AND BENDY WHICH HAS IMPLICATIONS WITH FLOW ON THE OSCILLATOR AND OFTEN STOPS THE OSCILLATOR. IT HAPPENED DURING USE, AND THE PATIENT BECAME BRADYCARDIC AND HAD TO BE MANUALLY VENTILATED. TUBING NEEDED TO BE PUT BACK ON/REPLACED AND SECURED WITH A TAPE.

  Patient problems: Bradycardia

  MAUDE report 13791230 ↗
• InjuryMar 16, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  THE CUSTOMER REPORTED THAT THE BOXED PAT CIRCUIT ASSY,3100A,FLTRD,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. IT HAPPENED DURING USE, AND THE PATIENT BECAME BRADYCARDIC AND HAD TO BE MANUALLY VENTILATED. ALSO, LUNG DERECRUITMENT OCCURRED.

  Patient problems: Bradycardia

  MAUDE report 13780410 ↗
• InjuryMar 16, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  THE CUSTOMER REPORTED THAT THE BOXED PAT CIRCUIT ASSY,3100A,FLTRD,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. IT HAPPENED DURING USE, AND THE PATIENT BECAME BRADYCARDIC AND HAD TO BE MANUALLY VENTILATED. ALSO, LUNG DERECRUITMENT OCCURRED.

  Patient problems: Bradycardia

  MAUDE report 13779839 ↗

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)