VixOne 0209Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00709078000393), received between Oct 4, 2024 and Oct 4, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE EIGHTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT, REFER TO 2028807-2024-00055 FOR THE SECOND REPORT , REFER TO 2028807-2024-00056 FOR THE THIRD REPORT , REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT , REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT, REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT, REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT, REFER TO 2028807-2024-00062 FOR THE NINTH REPORT, REFER TO 2028807-2024-00063 FOR THE TENTH REPORT , REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT, REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT, REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER(S) DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED TWICE; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20378436 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE TWELFTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT. REFER TO 2028807-2024-00055 FOR THE SECOND REPORT. REFER TO 2028807-2024-00056 FOR THE THIRD REPORT . REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT . REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT. REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT. REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT. REFER TO 2028807-2024-00061 FOR THE EIGHTH REPORT. REFER TO 2028807-2024-00062 FOR THE NINTH REPORT. REFER TO 2028807-2024-00063 FOR THE TENTH REPORT . REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT. REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20377786 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  (B)(6) RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE FIRST OF THIRTEEN REPORTS. REFER TO 2028807-2024-00055 FOR THE SECOND REPORT. REFER TO 2028807-2024-00056 FOR THE THIRD REPORT. REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT. REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT. REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT. REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT. REFER TO 2028807-2024-00061 FOR THE EIGHT REPORT. REFER TO 2028807-2024-00062 FOR THE NINTH REPORT. REFER TO 2028807-2024-00063 FOR THE TENTH REPORT. REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT. REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT. REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED TWICE; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20377779 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE SIXTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT, REFER TO 2028807-2024-00055 FOR THE SECOND REPORT , REFER TO 2028807-2024-00056 FOR THE THIRD REPORT, REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT , REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT, REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT, REFER TO 2028807-2024-00061 FOR THE EIGHTH REPORT , REFER TO 2028807-2024-00062 FOR THE NINTH REPORT , REFER TO 2028807-2024-00063 FOR THE TENTH REPORT , REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT, REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT AND, REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20377696 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE FIFTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT. REFER TO 2028807-2024-00055 FOR THE SECOND REPORT . REFER TO 2028807-2024-00056 FOR THE THIRD REPORT. REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT. REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT. REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT. REFER TO 2028807-2024-00061 FOR THE EIGHT REPORT REFER TO 2028807-2024-00062 FOR THE NINTH REPORT. REFER TO 2028807-2024-00063 FOR THE TENTH REPORT. REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT. REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT. REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER(S) DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20377375 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE THIRD OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT. REFER TO 2028807-2024-00055 FOR THE SECOND REPORT. REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT. REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT. REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT. REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT. REFER TO 2028807-2024-00061 FOR THE EIGHT REPORT. REFER TO 2028807-2024-00062 FOR THE NINTH REPORT. REFER TO 2028807-2024-00063 FOR THE TENTH REPORT. REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT. REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT. REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER(S) DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20377031 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE THIRTEENTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT. REFER TO 2028807-2024-00055 FOR THE SECOND REPORT . REFER TO 2028807-2024-00056 FOR THE THIRD REPORT . REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT. REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT. REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT. REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT. REFER TO 2028807-2024-00061 FOR THE EIGHTH REPORT. REFER TO 2028807-2024-00062 FOR THE NINTH REPORT. REFER TO 2028807-2024-00063 FOR THE TENTH REPORT. REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT. REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20376824 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE FOURTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT. REFER TO 2028807-2024-00055 FOR THE SECOND REPORT. REFER TO 2028807-2024-00056 FOR THE THIRD REPORT. REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT. REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT. REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT. REFER TO 2028807-2024-00061 FOR THE EIGHT REPORT. REFER TO 2028807-2024-00062 FOR THE NINTH REPORT. REFER TO 2028807-2024-00063 FOR THE TENTH REPORT. REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT. REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT. REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER(S) DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20376691 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE NINTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT, REFER TO 2028807-2024-00055 FOR THE SECOND REPORT, REFER TO 2028807-2024-00056 FOR THE THIRD REPORT, REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT, REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT, REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT, REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT, REFER TO 2028807-2024-00061 FOR THE EIGHTH REPORT, REFER TO 2028807-2024-00063 FOR THE TENTH REPORT, REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT, REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT, REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20376594 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE SEVENTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT, REFER TO 2028807-2024-00055 FOR THE SECOND REPORT, REFER TO 2028807-2024-00056 FOR THE THIRD REPORT, REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT, REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT, REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT, REFER TO 2028807-2024-00061 FOR THE EIGHT REPORT, REFER TO 2028807-2024-00062 FOR THE NINTH REPORT, REFER TO 2028807-2024-00063 FOR THE TENTH REPORT, REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT, REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT, REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20376315 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE TENTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT, REFER TO 2028807-2024-00055 FOR THE SECOND REPORT, REFER TO 2028807-2024-00056 FOR THE THIRD REPORT, REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT, REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT, REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT, REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT, REFER TO 2028807-2024-00061 FOR THE EIGHTH REPORT, REFER TO 2028807-2024-00062 FOR THE NINTH REPORT , REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT, REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT, REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20376123 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE SECOND OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT. REFER TO 2028807-2024-00056 FOR THE THIRD REPORT. REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT. REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT. REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT. REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT. REFER TO 2028807-2024-00061 FOR THE EIGHT REPORT. REFER TO 2028807-2024-00062 FOR THE NINTH REPORT. REFER TO 2028807-2024-00063 FOR THE TENTH REPORT. REFER TO 2028807-2024-00064 FOR THE ELEVENTH REPORT. REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT. REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20375395 ↗
• MalfunctionOct 4, 2024Failure to Infuse; Failure to Infuse

  (B)(6). RECEIVED A SINGLE REPORT THAT REFERENCED THIRTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THIRTEEN DIFFERENT PATIENTS. THIS IS THE ELEVENTH OF THIRTEEN REPORTS. REFER TO 2028807-2024-00037 FOR THE FIRST REPORT. REFER TO 2028807-2024-00055 FOR THE SECOND REPORT. REFER TO 2028807-2024-00056 FOR THE THIRD REPORT. REFER TO 2028807-2024-00057 FOR THE FOURTH REPORT. REFER TO 2028807-2024-00058 FOR THE FIFTH REPORT. REFER TO 2028807-2024-00059 FOR THE SIXTH REPORT. REFER TO 2028807-2024-00060 FOR THE SEVENTH REPORT. REFER TO 2028807-2024-00061 FOR THE EIGHTH REPORT. REFER TO 2028807-2024-00062 FOR THE NINTH REPORT. REFER TO 2028807-2024-00063 FOR THE TENTH REPORT. REFER TO 2028807-2024-00065 FOR THE TWELFTH REPORT. REFER TO 2028807-2024-00066 FOR THE THIRTEENTH REPORT. THE RESPIRATORY THERAPIST REPORTED, THE NEBULIZER DID NOT PRODUCE AEROSOL DURING USE; THE NEBULIZER WAS REPLACED; THERE WAS NO REPORTED INJURY OR DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20374800 ↗