Bivona FT18EN50NGF889NRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517153224), received between Jun 22, 2023 and Mar 6, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WATER GOES INTO THE PORT BUT WILL NOT INFLATE THE CUFF. THERE WAS A PATIENT INVOLVEMENT AND PATIENT HARM RECORDED. THE OPERATOR OF THE DEVICE WAS THE LAY USER OR PATIENT AND IT DID OCCUR AT THE PATIENT'S HOME. THE CONTINUED LEAKING CUFF CAUSED PNEUMONIA AND CHOCKING. HOSPITALIZATION FOR ONE WEEK ON ANTIBIOTICS BUT THE MOST RECENT WAS AN EMERGENCY TRACH CHANGE. THE OUTCOME OF THE EVENT HAS BEEN REPORTED AS RESOLVED.

  Patient problems: Choking; Pneumonia

  MAUDE report 18848162 ↗
• MalfunctionNov 22, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS LEAKING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THE EVENT OCCURRED AT PATIENTS HOME. THE DATE OF EVENT WAS NOT SPECIFIED. "IT HAPPENED 2.5 WEEKS AGO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18195021 ↗
• MalfunctionNov 22, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD A LEAKING CUFF. THERE WAS "PATIENT INVOLVEMENT BEFORE. HOWEVER, THERE WAS NO PATIENT HARM." EVENT OCCURRED AT THE PATIENTS HOME. THE DATE OF EVENT WAS NOT SPECIFIED. IT WAS REPORTED TO HAVE HAPPENED "2.5 WEEKS AGO". EVENT RESOLUTION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194743 ↗
• MalfunctionJun 22, 2023Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT'S MOTHER FOUND ONGOING LEAKING ISSUES WITH THE PATIENT'S TRACH. SHE HAS BEEN ABLE TO EXTEND THE USAGE OF MOST TRACHS BY REFILLING THEM. IT WAS ALSO MENTIONED THAT SHE HAD COMPLAINED TO HER DOCTOR ABOUT THE LEAKS BACK IN JANUARY. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE DOCTOR HAD ALREADY REQUESTED THE DEVICE REPLACEMENT THROUGH A WRITTEN PRESCRIPTION. NO PATIENT INJURY OR ADVERSE AFFECTS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184154 ↗
• MalfunctionJun 22, 2023Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT'S MOTHER FOUND ONGOING LEAKING ISSUES WITH THE PATIENT'S TRACH. SHE HAS BEEN ABLE TO EXTEND THE USAGE OF MOST TRACHS BY REFILLING THEM. IT WAS ALSO MENTIONED THAT SHE HAD COMPLAINED TO HER DOCTOR ABOUT THE LEAKS BACK IN JANUARY. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE DOCTOR HAD ALREADY REQUESTED THE DEVICE REPLACEMENT THROUGH A WRITTEN PRESCRIPTION. NO PATIENT INJURY OR ADVERSE AFFECTS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184060 ↗

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.