Bivona FT20DN40NGF895NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517227147), received between Jan 6, 2023 and Jan 6, 2023 — classified as 4 injuries.

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

• InjuryJan 6, 2023Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT ON THE FIRST TRACH, THE FLANGE RIPPED ALL THE WAY THROUGH, AND THIS TRACH FELL OUT. ON THE SECOND, THE AREA BEHIND THE HUB WITH THE METAL COILS HAD A PORTION WHERE THE COILS WERE POPPING THROUGH THE SILICONE. AT CERTAIN ANGLES, THEY COULD HEAR AIR ESCAPE. CUSTOMER STATED THAT 5 OF THE LAST 6 MONTHS HAVE BEEN PROBLEMATIC. THIS IS NOW FIVE CUSTOM TRACHS THAT HAVE FAILED IN THE LAST SIX MONTHS. ADDITIONAL INFORMATION: CUSTOMER HAS ONE TRACH WITH A TORN FLANGE ISSUE. CUSTOMER APPARENTLY THREW OUT THE OTHER PROBLEMATIC TRACHS OVER THE PAST 6 MONTHS. CUSTOMER IS UTILIZING 1 TRACH/MONTH AS THE NORM. CUSTOMER STATED THEY HAD DIFFERENT ISSUES WITH SEVERAL OF THESE CUSTOM TRACHS. THE INCIDENT OCCURS IMMEDIATE TO DAYS, TO WEEKS OF USE, BUT NOT MONTHS ON THE SAME TRACH. ADDITIONAL INFORMATION RECEIVED ON 21-DEC-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: EVENT DATES, LOT NUMBERS FOR EACH EVENT AND QUANTITIES WERE UPDATED. UPDATED EVENT DETAILS AND AFFECTED ITEMS IN COMPLAINT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113082 ↗
• InjuryJan 6, 2023Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT ON THE FIRST TRACH, THE FLANGE RIPPED ALL THE WAY THROUGH, AND THIS TRACH FELL OUT. ON THE SECOND, THE AREA BEHIND THE HUB WITH THE METAL COILS HAD A PORTION WHERE THE COILS WERE POPPING THROUGH THE SILICONE. AT CERTAIN ANGLES, THEY COULD HEAR AIR ESCAPE. CUSTOMER STATED THAT 5 OF THE LAST 6 MONTHS HAVE BEEN PROBLEMATIC. THIS IS NOW FIVE CUSTOM TRACHS THAT HAVE FAILED IN THE LAST SIX MONTHS. ADDITIONAL INFORMATION: CUSTOMER HAS ONE TRACH WITH A TORN FLANGE ISSUE. CUSTOMER APPARENTLY THREW OUT THE OTHER PROBLEMATIC TRACHS OVER THE PAST 6 MONTHS. CUSTOMER IS UTILIZING 1 TRACH/MONTH AS THE NORM. CUSTOMER STATED THEY HAD DIFFERENT ISSUES WITH SEVERAL OF THESE CUSTOM TRACHS. THE INCIDENT OCCURS IMMEDIATE TO DAYS, TO WEEKS OF USE, BUT NOT MONTHS ON THE SAME TRACH. ADDITIONAL INFORMATION RECEIVED ON 21-DEC-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: EVENT DATES, LOT NUMBERS FOR EACH EVENT AND QUANTITIES WERE UPDATED. UPDATED EVENT DETAILS AND AFFECTED ITEMS IN COMPLAINT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112915 ↗
• InjuryJan 6, 2023Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT ON THE FIRST TRACH, THE FLANGE RIPPED ALL THE WAY THROUGH, AND THIS TRACH FELL OUT. ON THE SECOND, THE AREA BEHIND THE HUB WITH THE METAL COILS HAD A PORTION WHERE THE COILS WERE POPPING THROUGH THE SILICONE. AT CERTAIN ANGLES, THEY COULD HEAR AIR ESCAPE. CUSTOMER STATED THAT 5 OF THE LAST 6 MONTHS HAVE BEEN PROBLEMATIC. THIS IS NOW FIVE CUSTOM TRACHS THAT HAVE FAILED IN THE LAST SIX MONTHS. ADDITONAL INFORMATION: CUSTOMER HAS ONE TRACH WITH A TORN FLANGE ISSUE. CUSTOMER APARANTLY THREW OUT THE OTHER PROBLEMATIC TRACHS OVER THE PAST 6 MONTHS. CUSTOMER IS UTILIZING 1 TRACH/MONTH AS THE NORM. CUSTOMER STATED THEY HAD DIFFERENT ISSUES WITH SEVERAL OF THESE CUSTOM TRACHS. THE INCIDENT OCCURS IMMEDIATE TO DAYS, TO WEEKS OF USE, BUT NOT MONTHS ON THE SAME TRACH. ADDITIONAL INFORMATION RECEIVED ON 21-DEC-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: EVENT DATES, LOT NUMBERS FOR EACH EVENT AND QUANTITIES WERE UPDATED. UPDATED EVENT DETAILS AND AFFECTED ITEMS IN COMPLAINT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112912 ↗
• InjuryJan 6, 2023Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT ON THE FIRST TRACH, THE FLANGE RIPPED ALL THE WAY THROUGH, AND THIS TRACH FELL OUT. ON THE SECOND, THE AREA BEHIND THE HUB WITH THE METAL COILS HAD A PORTION WHERE THE COILS WERE POPPING THROUGH THE SILICONE. AT CERTAIN ANGLES, THEY COULD HEAR AIR ESCAPE. CUSTOMER STATED THAT 5 OF THE LAST 6 MONTHS HAVE BEEN PROBLEMATIC. THIS IS NOW FIVE CUSTOM TRACHS THAT HAVE FAILED IN THE LAST SIX MONTHS. ADDITIONAL INFORMATION: CUSTOMER HAS ONE TRACH WITH A TORN FLANGE ISSUE. CUSTOMER APPARENTLY THREW OUT THE OTHER PROBLEMATIC TRACHS OVER THE PAST 6 MONTHS. CUSTOMER IS UTILIZING 1 TRACH/MONTH AS THE NORM. CUSTOMER STATED THEY HAD DIFFERENT ISSUES WITH SEVERAL OF THESE CUSTOM TRACHS. THE INCIDENT OCCURS IMMEDIATE TO DAYS, TO WEEKS OF USE, BUT NOT MONTHS ON THE SAME TRACH. ADDITIONAL INFORMATION RECEIVED ON 21-DEC-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: EVENT DATES, LOT NUMBERS FOR EACH EVENT AND QUANTITIES WERE UPDATED. UPDATED EVENT DETAILS AND AFFECTED ITEMS IN COMPLAINT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112861 ↗

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.