SuperNO2VA SSL-20 (UDI 10190752145467)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10190752145467), received between Dec 16, 2020 and Feb 20, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT HAS BEEN REPORTED THAT: I WAS SPEAKING WITH (B)(6), OR MANAGER, AND SHE SAID THE STRAP FROM THE MASK WAS BREAKING. I WILL CLARIFY AS TO THE EXACT NUMBER OF INSTANCES THIS OCCURRED. IT WAS FOUND THAT THERE WAS 3 INCIDENTS WITH THIS PRODUCT , OF WHICH WILL BE REPORTED ON 3 DIFFERENT REPORTS. THE SECOND REPORT NUMBER IS 8030673-2022-00005, AND THE THRID REPORT IS 8030673-2025-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424033 ↗
• MalfunctionJan 29, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT HAS BEEN REPORTED THAT: I WAS SPEAKING WITH (B)(6), OR MANAGER, AND SHE SAID THE STRAP FROM THE MASK WAS BREAKING. I WILL CLARIFY AS TO THE EXACT NUMBER OF INSTANCES THIS OCCURRED. IT WAS FOUND THAT THERE WAS 3 INCIDENTS WITH THIS PRODUCT , OF WHICH WILL BE REPORTED ON 3 DIFFERENT REPORTS. THE SECOND REPORT NUMBER IS 8030673-2022-00005, AND THE SECOND REPORT IS 8030673-2025-00004.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264336 ↗
• MalfunctionJan 29, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT HAS BEEN REPORTED THAT: I WAS SPEAKING WITH (B)(6), OR MANAGER, AND SHE SAID THE STRAP FROM THE MASK WAS BREAKING. I WILL CLARIFY AS TO THE EXACT NUMBER OF INSTANCES THIS OCCURRED. IT WAS FOUND THAT THERE WERE 3 INCIDENTS WITH THIS PRODUCT, OF WHICH WILL BE REPORTED ON 3 DIFFERENT REPORTS. THE FIRST REPORT NUMBER IS 8030673-2022-00004, AND THE THIRD REPORT IS 8030673-2025-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264335 ↗
• MalfunctionJan 29, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT HAS BEEN REPORTED THAT: I WAS SPEAKING WITH TIFFANY GUINTHER, OR MANAGER, AND SHE SAID THE STRAP FROM THE MASK WAS BREAKING. I WILL CLARIFY AS TO THE EXACT NUMBER OF INSTANCES THIS OCCURRED. IT WAS FOUND THAT THERE WERE 3 INCIDENTS WITH THIS PRODUCT, OF WHICH WILL BE REPORTED ON 3 DIFFERENT REPORS. THE SECOND REPORT NUMBER IS 8030673-2022-00005, AND THE THRID REPORTT IS 8030673-2025-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264334 ↗
• MalfunctionJun 20, 2022Product Quality Problem; Product Quality Problem

  THE CUSTOMER REPORTED THAT THE SSL-20-SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE) 50-R3439-07 WAS USED DURING AN UPPER ENDOSCOPY. THE DEVICE WAS DEFECTIVE, HAD MULTIPLE HOLES AT THE END OF THE BAG AND THE COLOR FADED. THE DEVICE WAS KEPT AWAY. ACCORDING TO THE CRNA AND ANESTHESIOLOGIST, THE SAME ISSUE HAPPENED BEFORE. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750320 ↗
• MalfunctionJan 17, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE ELASTIC BAG DESIGNED TO MANUALLY ASSIST BREATHING HAD MULTIPLE HOLES FORMED AT THE FOLDED SEAMS OF THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266426 ↗
• MalfunctionJan 17, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE ELASTIC BAG DESIGNED TO MANUALLY ASSIST BREATHING HAD MULTIPLE HOLES FORMED AT THE FOLDED SEAMS OF THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266412 ↗
• MalfunctionJan 17, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE ELASTIC BAG DESIGNED TO MANUALLY ASSIST BREATHING HAD MULTIPLE HOLES FORMED AT THE FOLDED SEAMS OF THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266402 ↗
• MalfunctionDec 16, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED THAT THE SUPERNO2VA SATELLITE KIT LARGE 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 11024386 ↗