Bivona FT16LN45NGF077NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517088564), received between Nov 1, 2018 and Nov 1, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Noise, Audible” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2018Noise, Audible; Noise, Audible

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE WAS REPORTED TO HAVE INCREASED SECRETIONS, ELEVATED HEART RATE, ELEVATED RESPIRATORY RATE, O2 LEVEL DECREASE, AND TO BE NOISY. SUBSEQUENTLY, A TRACHEOSTOMY (TRACH) TUBE CHANGE OUT WAS REQUIRED AND THE PATIENT RECOVERED. IT WAS REPORTED THAT THE PATIENT RECOVERED AS "THE PERFECT TRACH WAS PLACED." THERE WERE NO FURTHER REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: Hypoxia; Increased Respiratory Rate; Tachycardia

  MAUDE report 8027842 ↗
• InjuryNov 1, 2018Noise, Audible; Noise, Audible

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE WAS REPORTED TO HAVE INCREASED SECRETIONS, ELEVATED HEART RATE, ELEVATED RESPIRATORY RATE, O2 LEVEL DECREASE, AND TO BE NOISY. SUBSEQUENTLY, A TRACHEOSTOMY (TRACH) TUBE CHANGE OUT WAS REQUIRED AND THE PATIENT RECOVERED. IT WAS REPORTED THAT THE PATIENT RECOVERED AS "THE PERFECT TRACH WAS PLACED." THERE WERE NO FURTHER REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: Hypoxia; Increased Respiratory Rate; Tachycardia

  MAUDE report 8027840 ↗
• InjuryNov 1, 2018Noise, Audible; Noise, Audible

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE WAS REPORTED TO HAVE INCREASED SECRETIONS, ELEVATED HEART RATE, ELEVATED RESPIRATORY RATE, O2 LEVEL DECREASE, AND TO BE NOISY. SUBSEQUENTLY, A TRACHEOSTOMY (TRACH) TUBE CHANGE OUT WAS REQUIRED AND THE PATIENT RECOVERED. IT WAS REPORTED THAT THE PATIENT RECOVERED AS "THE PERFECT TRACH WAS PLACED." THERE WERE NO FURTHER REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: Hypoxia; Increased Respiratory Rate; Tachycardia

  MAUDE report 8027838 ↗

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.