Bivona 35W080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15021312014389), received between Sep 3, 2022 and Sep 17, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K792035); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. SEVERAL LOTS WERE AFFECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442991 ↗
• MalfunctionSep 5, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. SEVERAL LOTS WERE AFFECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354206 ↗
• MalfunctionSep 4, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353796 ↗
• MalfunctionSep 4, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353786 ↗
• MalfunctionSep 4, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353779 ↗
• MalfunctionSep 4, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353774 ↗
• MalfunctionSep 4, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353772 ↗
• MalfunctionSep 4, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353760 ↗
• MalfunctionSep 4, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353693 ↗
• MalfunctionSep 3, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, AS THE BOTTOM OF THE PACKAGE WAS NOT SEALED COMPLETELY AND THE TUBE STICKS OUT OF THE END CAUSING THE PRODUCT NOT TO CLOSE PROPERLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K792035. One submission often covers many models, so check the product and lot details in each record.

• Z-0177-2022 · Aug 9, 2021 · Terminated
  Bivona Aire-Cuf Endotracheal Tube
• Z-0178-2022 · Aug 9, 2021 · Terminated
  Bivona Uncuffed Wire Endotracheal Tubes,