Bivona 670150Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15021312006025), received between Oct 4, 2019 and Jan 13, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Leak/Splash; Material Puncture/Hole; Pressure Problem

  IT WAS REPORTED THAT NO VOLUMES WERE SHOWING ON THE VENT, AND THE TRACH CUFF WAS VISIBLY DEFLATED. WHEN THEY EXAMINED THE TRACH THAT WAS REMOVED, THEY ATTEMPTED TO FILL THE CUFF WITH STERILE WATER AND THERE WAS A PINHOLE LEAK IN THE CUFF WITH A STREAM OF WATER NOTED. IT HAPPENED AGAIN WITH VENTILATOR ALARMING CIRCUIT DISCONNECT AND THE TRACH CUFF WAS LEAKING. THE CUSTOMER TRIED TO INSTILL A SMALL AMOUNT OF STERILE WATER INTO THE CUFF, THE PATIENT STARTED TO COUGH, AND THE CUFF LEAK REMAINED. THIS OCCURRED 3 TIMES ON THE SAME PATIENT. THE FIRST TRACH WAS DISCARDED, BUT THEY KEPT THE SECOND TWO. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056006 ↗
• MalfunctionJan 13, 2026Leak/Splash; Material Puncture/Hole; Pressure Problem

  IT WAS REPORTED THAT NO VOLUMES WERE SHOWING ON THE VENT, AND THE TRACH CUFF WAS VISIBLY DEFLATED. WHEN THEY EXAMINED THE TRACH THAT WAS REMOVED, THEY ATTEMPTED TO FILL THE CUFF WITH STERILE WATER AND THERE WAS A PINHOLE LEAK IN THE CUFF WITH A STREAM OF WATER NOTED. IT HAPPENED AGAIN WITH VENTILATOR ALARMING CIRCUIT DISCONNECT AND THE TRACH CUFF WAS LEAKING. THE CUSTOMER TRIED TO INSTILL A SMALL AMOUNT OF STERILE WATER INTO THE CUFF, THE PATIENT STARTED TO COUGH, AND THE CUFF LEAK REMAINED. THIS OCCURRED 3 TIMES ON THE SAME PATIENT. THE FIRST TRACH WAS DISCARDED, BUT THEY KEPT THE SECOND TWO. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055994 ↗
• MalfunctionJan 12, 2026Leak/Splash; Material Puncture/Hole; Pressure Problem

  IT WAS REPORTED THAT NO VOLUMES WERE SHOWING ON THE VENT, AND THE TRACH CUFF WAS VISIBLY DEFLATED. WHEN THEY EXAMINED THE TRACH THAT WAS REMOVED, THEY ATTEMPTED TO FILL THE CUFF WITH STERILE WATER AND THERE WAS A PINHOLE LEAK IN THE CUFF WITH A STREAM OF WATER NOTED. IT HAPPENED AGAIN WITH VENTILATOR ALARMING CIRCUIT DISCONNECT AND THE TRACH CUFF WAS LEAKING. THE CUSTOMER TRIED TO INSTILL A SMALL AMOUNT OF STERILE WATER INTO THE CUFF, THE PATIENT STARTED TO COUGH, AND THE CUFF LEAK REMAINED. THIS OCCURRED 3 TIMES ON THE SAME PATIENT. THE FIRST TRACH WAS DISCARDED, BUT THEY KEPT THE SECOND TWO. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044160 ↗
• MalfunctionNov 11, 2024Contamination; Material Discolored; Contamination; Material Discolored

  IT WAS REPORTED THAT THERE WAS SEVERE CONTAMINATION AND DISCOLORATION IN THE CANNULA MATERIAL AFTER FIVE DAYS OF BEING IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652089 ↗
• MalfunctionJun 21, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE PART USED TO CUFF IN AND OUT OF THE TRACHEA FELL OFF COMPLETELY RIGHT WHERE THE AIRBAG ENDS. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585279 ↗
• InjuryAug 31, 2022Fracture; Inflation Problem; Gas/Air Leak; Fracture; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE HAD TO DO AN URGENT TRACH CHANGE FOR THE PATIENT DUE TO AN AIR LEAK. THE CAUSE OF THE AIR LEAK WAS APPARENT, POST CHANGE - THERE WAS A CRACK OR PIN HOLE IN THE BALLOON WHICH WAS CAUSING THE AIR LEAK. NO PATIENT HARM AND NO MEDICAL INTERVENTION AS THE EMERGENCY TRACH CHANGE FIXED THE ISSUE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15330964 ↗
• InjuryOct 14, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, THE CUFF WAS NOTED TO HAVE A PINHOLE LEAK. THIS RESULTED IN A TRACHEOSTOMY TUBE CHANGE OUT. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 9184894 ↗
• InjuryOct 4, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, THE CUFF WAS NOTED TO HAVE A PINHOLE LEAK. THIS RESULTED IN A TRACHEOSTOMY TUBE CHANGE OUT. NO FADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 9158809 ↗
• InjuryOct 4, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, THE CUFF WAS NOTED TO HAVE A PINHOLE LEAK. THIS RESULTED IN A TRACHEOSTOMY TUBE CHANGE OUT. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 9158808 ↗
• InjuryOct 4, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, THE CUFF WAS NOTED TO HAVE A PINHOLE LEAK. THIS RESULTED IN A TRACHEOSTOMY TUBE CHANGE OUT. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 9158807 ↗
• InjuryOct 4, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, THE CUFF WAS NOTED TO HAVE A PINHOLE LEAK. THIS RESULTED IN A TRACHEOSTOMY TUBE CHANGE OUT. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 9158805 ↗
• InjuryOct 4, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, THE CUFF WAS NOTED TO HAVE A PINHOLE LEAK. THIS RESULTED IN A TRACHEOSTOMY TUBE CHANGE OUT. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 9158803 ↗