Bivona FT17AN40NGF950NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517091403), received between May 26, 2023 and May 26, 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.

• InjuryMay 26, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY WAS OUT OF PATIENT'S NECK. UPON INSPECTION IT WAS FOUND THAT THE FLANGE LOOP ON TRACH BROKE ALLOWING TRACH TIES TO BECOME DISCONNECTED. THE PATIENT WAS THEN ABLE TO PULL THE TRACH OUT CAUSING DESATURATIONS AND BRADYCARDIA DUE TO LOSS OF AIRWAY. A NEW, EMERGENCY TRACH WAS INSERTED, AND PATIENT RECOVERED. DURING TRACH CARE WHILE THE NURSE WAS TYING TRACH TIES TO SECURE THE TRACH, A SNAP NOISE WAS HEARD AND NOTICED THE TRACH FLANGE HAD SPLIT AND BROKEN; AN UNPLANNED TRACH CHANGE WAS PERFORMED.

  Patient problems: Decreased Respiratory Rate; Respiratory Insufficiency

  MAUDE report 17010559 ↗
• InjuryMay 26, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY WAS OUT OF PATIENT'S NECK. UPON INSPECTION IT WAS FOUND THAT THE FLANGE LOOP ON TRACH BROKE ALLOWING TRACH TIES TO BECOME DISCONNECTED. THE PATIENT WAS THEN ABLE TO PULL THE TRACH OUT CAUSING DESATURATIONS AND BRADYCARDIA DUE TO LOSS OF AIRWAY. A NEW, EMERGENCY TRACH WAS INSERTED, AND PATIENT RECOVERED. DURING TRACH CARE WHILE THE NURSE WAS TYING TRACH TIES TO SECURE THE TRACH, A "SNAP" NOISE WAS HEARD AND NOTICED THE TRACH FLANGE HAD SPLIT AND BROKEN; AN UNPLANNED TRACH CHANGE WAS PERFORMED.

  Patient problems: Decreased Respiratory Rate; Respiratory Insufficiency

  MAUDE report 17010464 ↗
• InjuryMay 26, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY WAS OUT OF PATIENT'S NECK. UPON INSPECTION IT WAS FOUND THAT THE FLANGE LOOP ON TRACH BROKE ALLOWING TRACH TIES TO BECOME DISCONNECTED. THE PATIENT WAS THEN ABLE TO PULL THE TRACH OUT CAUSING DESATURATIONS AND BRADYCARDIA DUE TO LOSS OF AIRWAY. A NEW, EMERGENCY TRACH WAS INSERTED, AND PATIENT RECOVERED. DURING TRACH CARE WHILE THE NURSE WAS TYING TRACH TIES TO SECURE THE TRACH, A "SNAP" NOISE WAS HEARD AND NOTICED THE TRACH FLANGE HAD SPLIT AND BROKEN; AN UNPLANNED TRACH CHANGE WAS PERFORMED.

  Patient problems: Decreased Respiratory Rate; Respiratory Insufficiency

  MAUDE report 17010451 ↗
• InjuryMay 26, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY WAS OUT OF PATIENT'S NECK. UPON INSPECTION IT WAS FOUND THAT THE FLANGE LOOP ON TRACH BROKE ALLOWING TRACH TIES TO BECOME DISCONNECTED. THE PATIENT WAS THEN ABLE TO PULL THE TRACH OUT CAUSING DESATURATIONS AND BRADYCARDIA DUE TO LOSS OF AIRWAY. A NEW, EMERGENCY TRACH WAS INSERTED, AND PATIENT RECOVERED. DURING TRACH CARE WHILE THE NURSE WAS TYING TRACH TIES TO SECURE THE TRACH, A ?SNAP" NOISE WAS HEARD AND NOTICED THE TRACH FLANGE HAD SPLIT AND BROKEN; AN UNPLANNED TRACH CHANGE WAS PERFORMED.

  Patient problems: Decreased Respiratory Rate; Respiratory Insufficiency

  MAUDE report 17010436 ↗

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.