SuperNO2VA SSM-20 (UDI 10190752145443)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10190752145443), received between Mar 11, 2020 and May 23, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 1314417-2025-00032 FOR THE FIRST REPORT, REFER TO 1314417-2025-00034 FOR THE THIRD REPORT, REFER TO 1314417-2025-00035 FOR THE FOURTH REPORT. IT WAS REPORTED, DURING USE HOLE(S) WERE DISCOVERED IN THE GREEN BAG. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081877 ↗
• MalfunctionMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 1314417-2025-00033 FOR THE SECOND REPORT. REFER TO 1314417-2025-00034 FOR THE THIRD REPORT. REFER TO 1314417-2025-00035 FOR THE FOURTH REPORT. IT WAS REPORTED, DURING USE HOLE(S) WERE DISCOVERED IN THE GREEN BAG. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081875 ↗
• MalfunctionAug 25, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED THAT THE SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) EXPERIENCED TEAR IN THE BAG DURING SETUP. THE FIRST OPTION WAS TO SWITCH THE BAG BUT THE CRNA OPTED TO PUT TAPE OVER THE TEAR IN THE BAG. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366181 ↗
• MalfunctionMay 11, 2021Misassembled; Misassembled

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE ABS BAG ARM CONNECTOR ELBOW OF SUPERNOVA NASAL PAP VENTILATION SYSTEM WAS PUT ON BACKWARDS NOT ALLOWING IT TO CONNECT TO THE ANESTHESIA MACHINE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807424 ↗
• MalfunctionDec 16, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED THAT THE SUPERNO2VA SATELLITE KIT MEDIUM EXPERIENCED MULTIPLE TEARS IN BAGS WHERE THEY HAVE BEEN CREASED IN PACKAGES. THE REPORTED ISSUE WAS DETECTED DURING PATIENT USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024385 ↗
• MalfunctionNov 10, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING CLINICAL SETTINGS, THE SSM-20 SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) WAS NOT INFLATING, AND HOLES WERE DETECTED. AS A RESOLUTION, THE BAG WAS REPLACED, AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10820278 ↗
• MalfunctionMar 11, 2020Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER REPORTED THAT THE SUPERNO2VA SATELLITE KIT EXPERIENCED OXYGEN LEAK WHERE THE GREEN O2 CONNECTOR MEETS CLEAR TUBING DURING PATIENT USE. THE CUSTOMER CONFIRMED NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9816982 ↗