Bivona FT19AN60NSF077NRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15019517178364), received between Sep 13, 2022 and Sep 19, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WAS UNEVEN INFLATION AND SPECIFICATIONS FOUND IN MULTIPLE CUFFS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445033 ↗
• MalfunctionSep 16, 2022Degraded; Inflation Problem; Degraded; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF INFLATION WAS UNEVEN AND SPECS WERE OBSERVED IN THE CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437258 ↗
• MalfunctionSep 16, 2022Degraded; Inflation Problem; Degraded; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF INFLATION WAS UNEVEN AND SPECS WERE OBSERVED IN THE CUFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437208 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT UNEVEN INFLATION AND SPEC FOUND IN MULTIPLE CUFFS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436843 ↗
• MalfunctionSep 15, 2022Degraded; Inflation Problem; Degraded; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF INFLATION WAS UNEVEN AND SPECS WERE OBSERVED IN THE CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426745 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WAS UNEVEN INFLATION FOUND IN MULTIPLE CUFFS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418530 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WAS UNEVEN INFLATION FOUND IN MULTIPLE CUFFS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418184 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WAS UNEVEN INFLATION FOUND IN MULTIPLE CUFFS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418049 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WAS UNEVEN INFLATION FOUND IN MULTIPLE CUFFS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417774 ↗
• MalfunctionSep 13, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CUFFS HAD UNEVEN INFLATION AND SPEC FOUND. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411360 ↗

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.