Bivona FT16BN60NGF038NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517040531), received between May 24, 2022 and Dec 2, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K923878); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE CUFF WOULD NOT INFLATE. TWO LOT NUMBERS WERE REPORTED. NO PATIENT INJURY WAS REPORTED. THE FIRST LOT NUMBER WAS PREVIOUSLY REPORTED ON MEDWATCH NUMBER 3012307300-2022-27181. FURTHER DETAILS HAVE BEEN REQUESTED TO DETERMINE IF THERE WERE TWO ITEMS USED IN THIS INCIDENT OR IF THE FIRST LOT NUMBER WAS ONLY FAULTY ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905732 ↗
• MalfunctionNov 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WILL NOT INFLATE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799401 ↗
• MalfunctionMay 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRACH WAS DEFLATING AFTER INSERTION. DUE TO THIS, THE TRACH WAS REMOVED FROM THE PATIENT TO BE TESTED. ONCE THE TRACH WAS REMOVED, IT WAS FILLED AND LEFT OUT TO SEE IF IT WOULD STAY INFLATED. IT DID NOT. NO PATIENT HARM WAS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492878 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.