Bivona FT21CN40NSC156NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517262421), received between Feb 10, 2022 and Feb 10, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A ROUND DISK IN FRONT OF NECK FLANGE IS CAUSING RESPIRATORY DISTRESS FOR CHILD. THIS WAS RESOLVED BY INSERTING A STOCK TRACH. THIS HAPPENED TWICE. UPON FOLLOW UP, IT WAS FOUND THAT THE NECK FLANGE CONFIGURATION OF C WAS SELECTED ON THE TEMPLATE IN ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Respiratory Insufficiency

  MAUDE report 13510079 ↗
• InjuryFeb 10, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE ROUND DISK IN FRONT OF NECK FLANGE IS CAUSING RESPIRATORY DISTRESS FOR CHILD. THIS WAS RESOLVED BY INSERTING A STOCK TRACH. THIS HAPPENED TWICE. UPON FOLLOW UP, IT WAS FOUND THAT THE NECK FLANGE CONFIGURATION OF C WAS SELECTED ON THE TEMPLATE IN ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509764 ↗

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.