Bivona FT17LN35NGE059NRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15019517135053), received between Sep 26, 2022 and May 26, 2023 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Fracture; Inflation Problem; Gas/Air Leak; Fracture; Inflation Problem; Gas/Air Leak

  A CUSTOMER REPORTED THAT AN EMERGENCY TRACHEOSTOMY CHANGE HAD TO BE PERFORMED DUE TO THE TRACHEOSTOMY CUFF NOT INFLATING SUFFICIENTLY. IT WAS STATED ALSO ON THE INSPECTION, IT APPEARED THAT THERE'S A HOLE/SPLIT IN THE CUFF OF THE TRACHEOSTOMY. THEREFORE WATER LEAKS OUT AND THE CUFF DOES NOT INFLATE. NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17010088 ↗
• MalfunctionMay 26, 2023Fracture; Inflation Problem; Gas/Air Leak; Fracture; Inflation Problem; Gas/Air Leak

  A CUSTOMER REPORTED THAT AN EMERGENCY TRACHEOSTOMY CHANGE HAD TO BE PERFORMED DUE TO THE TRACHEOSTOMY CUFF NOT INFLATING SUFFICIENTLY. IT WAS STATED ALSO ON THE INSPECTION, IT APPEARED THAT THERE'S A HOLE/SPLIT IN THE CUFF OF THE TRACHEOSTOMY. THEREFORE WATER LEAKS OUT AND THE CUFF DOES NOT INFLATE. NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17010077 ↗
• MalfunctionMay 26, 2023Fracture; Inflation Problem; Gas/Air Leak; Fracture; Inflation Problem; Gas/Air Leak

  A CUSTOMER REPORTED THAT AN EMERGENCY TRACHEOSTOMY CHANGE HAD TO BE PERFORMED DUE TO THE TRACHEOSTOMY CUFF NOT INFLATING SUFFICIENTLY. IT WAS STATED ALSO ON THE INSPECTION, IT APPEARED THAT THERE'S A HOLE/SPLIT IN THE CUFF OF THE TRACHEOSTOMY. THEREFORE WATER LEAKS OUT AND THE CUFF DOES NOT INFLATE. NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17010074 ↗
• InjuryOct 7, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT HAS BEEN REPORTED THAT THE VALVE USED TO INFLATE THE CUFF WAS FALLING OUT OF THE TRACHEOSTOMY. IT WAS DISCOVERED PRIOR TO PATIENT USE AND WHILE IT WAS BEING USED VIA THE PATIENT. IT RESULTED IN A TRACHEOSTOMY TUBE CHANGE AS THE CUFF COULD NOT BE INFLATED. IT WAS ADVISED THAT THIS HAS HAPPENED TO APPROX. SEVEN TRACHEOSTOMIES AND THIS ALSO OCCURRED WHILE THE PATIENT WAS AN INPATIENT IN HOSPITAL. A FURTHER TWO TRACHEOSTOMIES WERE PROVIDED TO THE FAMILY ON DISCHARGE HOME AS HE ONLY HAD ONE THAT WAS INSTITUTE. THEN A FURTHER ONE WAS TAKEN TO THE FAMILY TEN DAYS LATER WHICH TOTALS UP TO SEVEN TRACHEOSTOMIES FROM (B)(6) 2022 TILL (B)(6) 2022. NO PATIENT INJURY REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15563991 ↗
• InjuryOct 5, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT HAS BEEN REPORTED THAT THE VALVE USED TO INFLATE THE CUFF WAS FALLING OUT OF THE TRACHEOSTOMY. IT WAS DISCOVERED PRIOR TO PATIENT USE AND WHILE IT WAS BEING USED VIA THE PATIENT. IT RESULTED IN A TRACHEOSTOMY TUBE CHANGE AS THE CUFF COULD NOT BE INFLATED. IT WAS ADVISED THAT THIS HAS HAPPENED TO APPROX. SEVEN TRACHEOSTOMIES AND THIS ALSO OCCURRED WHILE THE PATIENT WAS AN INPATIENT IN HOSPITAL. A FURTHER TWO TRACHEOSTOMIES WERE PROVIDED TO THE FAMILY ON DISCHARGE HOME AS HE ONLY HAD ONE THAT WAS INSTITUTE. THEN A FURTHER ONE WAS TAKEN TO THE FAMILY TEN DAYS LATER WHICH TOTALS UP TO SEVEN TRACHEOSTOMIES FROM (B)(6) 2022 TILL (B)(6) 2022. NO PATIENT INJURY REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15545375 ↗
• InjurySep 27, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT HAS BEEN REPORTED THAT THE VALVE USED TO INFLATE THE CUFF WAS FALLING OUT OF THE TRACHEOSTOMY. IT WAS DISCOVERED PRIOR TO PATIENT USE AND WHILE IT WAS BEING USED VIA THE PATIENT. IT RESULTED IN A TRACHEOSTOMY TUBE CHANGE AS THE CUFF COULD NOT BE INFLATED. IT WAS ADVISED THAT THIS HAS HAPPENED TO APPROX. SEVEN TRACHEOSTOMIES AND THIS ALSO OCCURRED WHILE THE PATIENT WAS AN INPATIENT IN HOSPITAL. A FURTHER TWO TRACHEOSTOMIES WERE PROVIDED TO THE FAMILY ON DISCHARGE HOME AS HE ONLY HAD ONE THAT WAS INSTITUTE. THEN A FURTHER ONE WAS TAKEN TO THE FAMILY TEN DAYS LATER WHICH TOTALS UP TO SEVEN TRACHEOSTOMIES FROM (B)(6) 2022 TILL (B)(6) 2022. NO PATIENT INJURY REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15490975 ↗
• MalfunctionSep 26, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT HAS BEEN REPORTED THAT THE VALVE USED TO INFLATE THE CUFF WAS FALLING OUT OF THE TRACHEOSTOMY. IT WAS DISCOVERED PRIOR TO PATIENT USE AND WHILE IT WAS BEING USED VIA THE PATIENT. IT RESULTED IN A TRACHEOSTOMY TUBE CHANGE AS THE CUFF COULD NOT BE INFLATED. IT WAS ADVISED THAT THIS HAS HAPPENED TO APPROX. SEVEN TRACHEOSTOMIES AND THIS ALSO OCCURRED WHILE THE PATIENT WAS AN INPATIENT IN HOSPITAL. A FURTHER TWO TRACHEOSTOMIES WERE PROVIDED TO THE FAMILY ON DISCHARGE HOME AS HE ONLY HAD ONE THAT WAS INSTITUTE. THEN A FURTHER ONE WAS TAKEN TO THE FAMILY TEN DAYS LATER WHICH TOTALS UP TO SEVEN TRACHEOSTOMIES FROM JULY 2022 TILL MID-AUGUST 2022. NO PATIENT INJURY REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15485094 ↗
• MalfunctionSep 26, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT HAS BEEN REPORTED THAT THE VALVE USED TO INFLATE THE CUFF WAS FALLING OUT OF THE TRACHEOSTOMY. IT WAS DISCOVERED PRIOR TO PATIENT USE AND WHILE IT WAS BEING USED VIA THE PATIENT. IT RESULTED IN A TRACHEOSTOMY TUBE CHANGE AS THE CUFF COULD NOT BE INFLATED. IT WAS ADVISED THAT THIS HAS HAPPENED TO APPROX. SEVEN TRACHEOSTOMIES AND THIS ALSO OCCURRED WHILE THE PATIENT WAS AN INPATIENT IN HOSPITAL. A FURTHER TWO TRACHEOSTOMIES WERE PROVIDED TO THE FAMILY ON DISCHARGE HOME AS HE ONLY HAD ONE THAT WAS INSTITUTE. THEN A FURTHER ONE WAS TAKEN TO THE FAMILY TEN DAYS LATER WHICH TOTALS UP TO SEVEN TRACHEOSTOMIES FROM JULY 2022 TILL MID-AUGUST 2022. NO PATIENT INJURY REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15485086 ↗
• MalfunctionSep 26, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT HAS BEEN REPORTED THAT THE VALVE USED TO INFLATE THE CUFF WAS FALLING OUT OF THE TRACHEOSTOMY. IT WAS DISCOVERED PRIOR TO PATIENT USE AND WHILE IT WAS BEING USED VIA THE PATIENT. IT RESULTED IN A TRACHEOSTOMY TUBE CHANGE AS THE CUFF COULD NOT BE INFLATED. IT WAS ADVISED THAT THIS HAS HAPPENED TO APPROX. SEVEN TRACHEOSTOMIES AND THIS ALSO OCCURRED WHILE THE PATIENT WAS AN INPATIENT IN HOSPITAL. A FURTHER TWO TRACHEOSTOMIES WERE PROVIDED TO THE FAMILY ON DISCHARGE HOME AS HE ONLY HAD ONE THAT WAS INSTITUTE. THEN A FURTHER ONE WAS TAKEN TO THE FAMILY TEN DAYS LATER WHICH TOTALS UP TO SEVEN TRACHEOSTOMIES FROM (B)(6) 2022 TILL (B)(6) 2022. NO PATIENT INJURY REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15485083 ↗
• InjurySep 26, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT HAS BEEN REPORTED THAT THE VALVE USED TO INFLATE THE CUFF WAS FALLING OUT OF THE TRACHEOSTOMY. IT WAS DISCOVERED PRIOR TO PATIENT USE AND WHILE IT WAS BEING USED VIA THE PATIENT. IT RESULTED IN A TRACHEOSTOMY TUBE CHANGE AS THE CUFF COULD NOT BE INFLATED. IT WAS ADVISED THAT THIS HAS HAPPENED TO APPROX. SEVEN TRACHEOSTOMIES AND THIS ALSO OCCURRED WHILE THE PATIENT WAS AN INPATIENT IN HOSPITAL. A FURTHER TWO TRACHEOSTOMIES WERE PROVIDED TO THE FAMILY ON DISCHARGE HOME AS HE ONLY HAD ONE THAT WAS INSTITUTE. THEN A FURTHER ONE WAS TAKEN TO THE FAMILY TEN DAYS LATER WHICH TOTALS UP TO SEVEN TRACHEOSTOMIES FROM (B)(6) 2022 TILL (B)(6) 2022. NO PATIENT INJURY REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15485082 ↗

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.