Bivona FT15LN90NSC861NRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019517035322), received between Mar 23, 2017 and Mar 9, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Inflation Problem

  IT WAS REPORTED THAT THE CUFF INFLATION WAS ASYMMETRICAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545382 ↗
• InjuryOct 19, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENTS MOTHER CALLED IN STATING THAT "THE BALLOON ON THE TRACH WAS NOT INFLATING CORRECTLY". THE TRACH WAS REMOVED AND A NEW TRACH WAS PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966614 ↗
• InjuryMay 5, 2023Defective Device; Gas/Air Leak; Defective Device; Gas/Air Leak

  ADDITIONAL INFORMATION WAS RECEIVED: EVENT OCCURRED AT PATIENTS HOME. DEFECTIVE TRACH CUFF WAS IN USE AT THE TIME OF DISCOVERY. VENTILATOR WAS ALARMING AND AIR LEAK WAS NOTED. THERE WAS NO PATIENT INJURY. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION. TRACH WAS CHANGED OUT IMMEDIATELY. TRACH TUBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878193 ↗
• MalfunctionJul 15, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PILOT BALLOON HAD A HOLE IN IT CAUSING THE BALLOON NOT TO INFLATE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032441 ↗
• InjuryJun 5, 2017Material Too Rigid or Stiff; Device Operates Differently Than Expected; Material Too Rigid or Stiff; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE WAS NARROW AND STUFF, AND THE PATIENT EXPERIENCED RESPIRATORY DISTRESS. THE INCIDENT OCCURRED SHORTLY AFTER PLACEMENT. AIR WAS USED TO FILL THE CUFF. THE PATIENT COULD NOT MOVE AIR AND BECAME "DUSKY" AND BLUE, AND WAS EXPERIENCING RESPIRATORY DISTRESS. THE TRACHEOSTOMY TUBE WAS REPLACED WITH THE ONE THAT HAD JUST BEEN REMOVED. THE PATIENT CONSULTED WITH THEIR HEALTHCARE PROVIDER REGARDING THE INCIDENT. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Cyanosis; Respiratory Distress

  MAUDE report 6612274 ↗
• InjuryMar 23, 2017Defective Device; Infusion or Flow Problem; Defective Device; Infusion or Flow Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM ADULT TRACHEOSTOMY TUBE WAS DEFECTIVE AND POSSIBLY CAUSED AIRFLOW RESTRICTION DURING USE WITH A PATIENT. THE DEVICE WAS INSERTED IN THE PATIENT WHEN THE PATIENT WAS IN RESPIRATORY DISTRESS. THE CUFF PATENCY WAS TESTED BY THE PATIENT'S MOTHER PRIOR TO USE. THE CUFF WAS FILLED WITH AIR. AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WAS CONDUCTED, WHICH WAS REPORTED TO HAVE RESOLVED THE ISSUE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Extubate; Patient Problem/Medical Problem; Respiratory Distress

  MAUDE report 6427390 ↗

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.