Bivona FT19LN60NGA888NRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019517215823), received between Oct 11, 2021 and Jan 25, 2023 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT PATIENTS MOTHER INSERTED NEW TRACHEOSTOMY AND AFTER ONE HOUR, THE SON STATED THAT THE CUFF FELT DEFLATED. MOTHER INFLATED THE CUFF AND AFTER ANOTHER HOUR THE SAME ISSUE HAPPENED. MOTHER THEN TOOK OUT AND TESTED TWO NEW TRACHEOSTOMIES AND BOTH OF THEM WERE NOT INFLATING. MOTHER HAD NOT THROWN AWAY THE OLD TRACHEOSTOMY THAT WAS TAKEN OUT AND REPROCESSED IT TO USE ON SON. MOTHER CALLED EMS AND THEY WANTED TO ADMIT THE PATIENT BUT MOTHER REFUSED. THE CUSTOMER HAS TWO MORE TRACHEOSTOMIES THAT FAILED WHILE IN USE. THE MOTHER WAS IN THE ROOM WHEN SHE HEARD THE FIRST ONE POP. A TRACHEOSTOMY CHANGE WAS DONE TO RESOLVE THE ISSUE. THE NEXT TRACHEOSTOMY THAT WAS PUT IN HELD OVERNIGHT BUT WAS GIVING A LEAK ERROR. THE MOTHER TOOK IT OUT AND FOUND IT TO BE DEFLATED. SHE REINSERTED AND INFLATED AGAIN. MOTHER THEN TOOK THE SECOND TRACHEOSTOMY OUT AND INSERTED AN OLDER TRACH WITH NO DEFECT. THIS COMPLAINT IS FOR THE CUFF THAT WOULD NOT INFLATE DURING PRE-TEST. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244868 ↗
• MalfunctionJan 23, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16226191 ↗
• InjuryFeb 11, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT'S MOTHER INSERTED NEW TRACH AND AFTER ONE HOUR, THE SON STATED THAT THE CUFF FELT DEFLATED. MOTHER INFLATED THE CUFF AND AFTER ANOTHER HOUR THE SAME ISSUE HAPPENED. MOTHER THEN TOOK OUT AND TESTED TWO NEW TRACHS AND BOTH OF THEM WERE NOT INFLATING. MOTHER HAD NOT THROWN AWAY THE OLD TRACH THAT WAS TAKEN OUT AND REPROCESSED IT TO USE ON SON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514665 ↗
• MalfunctionNov 24, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A TRACH POPPED WITHIN 24 HOURS OF USE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869803 ↗
• MalfunctionNov 24, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A TRACH POPPED 24 HOURS WITHIN USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869498 ↗
• InjuryOct 11, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. IT WAS TAKEN OUT THEN REINSERTED DUE TO NO REPLACEMENTS BEING AVAILABLE AT THE TIME. WHEN A REPLACEMENT BECAME AVAILABLE, THE DEVICE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12607632 ↗
• InjuryOct 11, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKED AFTER A DAY IN USE. IT WAS PUT BACK IN DUE TO NO REPLACEMENT BEING AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12607160 ↗
• InjuryOct 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF POPPED WHILE IN USE. A TRACH CHANGE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606570 ↗

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.