Bivona 670175Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 15021312006063), received between Jun 12, 2017 and Jun 9, 2026 — classified as 15 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (13 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBING LEADING TO THE CUFF DETACHED DIRECTLY AT THE PILOT BALLOON. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT OR USER HARM REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445569 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBING LEADING TO THE CUFF DETACHED DIRECTLY AT THE PILOT BALLOON. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT OR USER HARM REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445560 ↗
• MalfunctionJun 5, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE DURING USE WITH PATIENT BIVONA TRACHEOSTOMY TUBE CUFF WAS NOTED TO BE LEAKING. THERE WAS PATIENT INVOLVEMENT. NO OTHER ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414503 ↗
• MalfunctionFeb 2, 2026Inflation Problem

  IT WAS REPORTED THAT WHEN DOING INFLATION DURING PRE-TEST THE WATER ABNORMALLY REMAINED IN THE PILOT BALLOON AND HAD DIFFICULTY ENTERING THE CUFF, AND RESISTANCE WAS OBSERVED. THE SAME PROBLEM SEEMED TO OCCUR DURING DEFLATION. ADDITIONALLY, IT SEEMED TO BE UNEVEN INFLATION ON BOTH SIDES OF CUFF. THE DEVICE IS AVAILABLE FOR INVESTIGATION. EVENT OCCURRED DURING PRE-TEST IN TAIWAN. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240279 ↗
• MalfunctionNov 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORT THAT WHEN THE PATIENT WAS PLACED ON A VENTILATOR, THE VENTILATOR ALARMED DUE TO AN AIR LEAK. TROUBLESHOOTING REVEALED THE LEAK WAS FROM THE TRACHEOSTOMY TUBE CUFF, THE VENTILATOR FUNCTIONED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657065 ↗
• MalfunctionNov 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A LEAKAGE FOLLOWING ONE DAY OF USE. A REPLACEMENT TUBE WAS USED AND THE ISSUE RESOLVED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526076 ↗
• MalfunctionMar 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN DOING INFLATION DURING PRE-TEST THE WATER ABNORMALLY REMAINED IN THE PILOT BALLOON AND HAD DIFFICULTY ENTERING THE CUFF, AND RESISTANCE WAS OBSERVED. THE SAME PROBLEM SEEMED TO OCCUR DURING DEFLATION. ADDITIONALLY, IT SEEMED TO BE UNEVEN INFLATION ON BOTH SIDES OF CUFF. THE DEVICE IS AVAILABLE FOR INVESTIGATION. EVENT OCCURRED DURING PRE-TEST IN TAIWAN. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536670 ↗
• MalfunctionJul 15, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FIRST TRACHEOSTOMY TUBE EXHIBITED A LEAK ON THE NEXT DAY AFTER THE PLACEMENT. THE SECOND TRACHEOSTOMY TUBE ALSO EXHIBITED A LEAK ON THE NEXT DAY AFTER PLACEMENT. THE ISSUE WAS RESOLVED AFTER CHANGING THE TRACHEOSTOMY TUBE TO A BIVONA TUBE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745558 ↗
• InjuryMay 20, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE WATER COULD NOT BE WITHDRAWN THROUGH THE PILOT BALLOON AFTER 29 DAYS OF USE, THUS INFLATION LINE WAS FORCED TO BE CUT TO WITHDRAW THE WATER AND REMOVE THE TUBE. THIS WAS SOLVED BY REPLACING WITH A NEW ONE. THERE WAS A PATIENT INVOLVEMENT, AND NO MEDICAL INTERVENTION WAS REQUIRED, AND THE ISSUE HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354981 ↗
• InjuryApr 24, 2024Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED FROM INTENSIVE CARE AND PRESENTED WITH RESPIRATORY DETERIORATION, AS CONGESTION AND DESATURATION. THE PATIENT HAD TO BE VENTILATED ON A PORTABLE VENTILATOR IN THE PNEUMOLOGY DEPARTMENT. DESPITE PRIOR RE-INFLATION OF THE CUFF WITH A VOLUME OF 6 ML, THE LEAKS HAVE PERSISTED. FACILITY INJECTED UP TO "18 ML AD" TO ELIMINATE THE LEAKS. SIGNIFICANT ASYMMETRY WAS ALSO OBSERVED AFTER A PRE-TEST OF THE BALLOON WITH AIR WHEN A 7.5MM CANNULA WAS CHANGED TO A 9MM CANNULA. AFTER TESTING WITH ANOTHER 9MM CANNULA, IT WAS OBSERVED TO HAVE PERFECT SYMMETRY OF THE BALLOON. THERE WAS PATIENT INVOLVEMENT AND THERE IS ADVERSE EVENT/HUMAN HARM. THE PLACE OF OCCURRENCE WAS THE HOSPITAL. THERE WAS NO INJURY, BUT THERE WAS NEED OF MEDICAL INTERVENTION.

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 19176030 ↗
• InjuryJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE VENTILATOR DISPLAYED AN AIR LEAKAGE ALARM DURING A WARD CHECK, AND THE WATER BAG LEAKED AFTER THE INTUBATION WAS CUT AND THE TUBE WAS REMOVED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607819 ↗
• MalfunctionSep 28, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A PRE-TEST, LEAKAGE FROM THE PILOT BALLOON WAS OBSERVED. NO INFORMATION ABOUT PATIENT INVOLVEMENT. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17830848 ↗
• MalfunctionJul 14, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE WHEN INSERTED BY NURSE. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17325123 ↗
• MalfunctionJul 14, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT CUFF LEAKAGE WAS FOUND DURING PRE-TEST. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325117 ↗
• MalfunctionJun 27, 2023Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT THE USER NOTICED A SMALL DISCOLORATION SPOT AFTER THE CUFF WAS INFLATED. DISCOVERED IMMEDIATELY ON USE. NO INJURY OR CLINICAL CONSEQUENCE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210915 ↗
• MalfunctionJun 5, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT USED THIS TUBE FOR ONE MONTH. SLIGHT LEAKAGE WAS FOUND ON CUFF AFTER REMOVAL FOR RE-PROCESSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061481 ↗
• MalfunctionApr 4, 2023Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT A TRACH HAD A CUFF LEAK THAT WAS DISCOVERED WHILE IN USE FOR TWELVE (12) DAYS WITH A PATIENT. LEAKAGE WAS CONFIRMED WHEN THE PRODUCT WAS WITHDRAWN FROM THE PATIENT AND FURTHER TESTED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677971 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT A CUFF LEAK WAS DISCOVERED DURING PRE-TEST AFTER REPROCESSING WHEN PRODUCT WAS ABOUT TO BE REINSTALLED INTO PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438851 ↗
• MalfunctionNov 16, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THE HEALTH PROFESSIONAL HAD DIFFICULTY INJECTING AND WITHDRAWING WATER FROM CUFF. THE EVENT OCCUR AT HOMECARE CLINIC. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 9-NOV-2022 : NO MEDICAL INTERVENTION. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808530 ↗
• InjuryOct 21, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACH TUBE HAD CUFF LEAKAGE THAT WAS DISCOVERED AROUND 72 HOURS AFTER INSERTION. THE ISSUE WAS RESOLVED WITH A TRACH TUBE CHANGE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15654735 ↗
• MalfunctionOct 13, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN OPENING AND PRE-TESTING CUFF PATENCY, THE CLINICIAN FOUND THAT THE CUFF LEAKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598836 ↗
• MalfunctionSep 22, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT UPON RECEIVING THE SHIPMENT AND CONDUCTING INCOMING INSPECTION, IT WAS FOUND THAT THERE WAS NO PRODUCT LABEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15464274 ↗
• MalfunctionFeb 15, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED DURING PRE-TEST OF THE TRACHEOSTOMY TUBE THERE WAS A CUFF LEAK. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535631 ↗
• InjuryOct 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PROBLEM WAS RESOLVED BY CHANGING THE TRACHEOSTOMY TUBE.

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

  MAUDE report 12606430 ↗
• MalfunctionJun 2, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE WAS LEAKING AT THE SHAFT. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 11922072 ↗