Bivona 670160Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 15021312006032), received between May 17, 2017 and Sep 18, 2026 — classified as 26 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829305 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829215 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829095 ↗
• InjuryAug 17, 2026Inflation Problem; Gas/Air Leak

  It was reported that a ventilator-dependent patient experienced acute respiratory compromise due to repeated cuff failures of Bivona Tight-to-Shaft tracheostomy tubes. The cuffs repeatedly failed to maintain inflation, causing major air leaks, low tidal volumes, increased ventilator pressures, oxygen desaturation, agitation, and respiratory distress. Emergency tube changes and other interventions were required. Similar cuff failures occurred with multiple tubes of the same brand and size, suggesting a possible device-related issue. The problem resolved after replacing the tube with a different size, restoring effective ventilation and the patient¿s baseline condition.

  Patient problems: Anxiety; Low Oxygen Saturation

  MAUDE report 50279857 ↗
• MalfunctionApr 6, 2026Partial Blockage; Deflation Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A TRACHEOSTOMY IN (B)(6) 2026 FOLLOWING A CERVICAL-MEDIASTINAL CELLULITIS EXPERIENCED DIFFICULTIES DURING VENTILATOR WEANING. THE TRACHEOSTOMY CANNULA CURRENTLY IN PLACE WAS INSERTED ON (B)(6) 2026 (DATE DEDUCED BUT NOT CERTAIN). AFTER AN HOUR AND A HALF VENTILATION EPISODE, THE PATIENT WAS PLACED ON HIGH-CONCENTRATION OXYGEN THERAPY WITH THE CUFF DEFLATED. THE PATIENT WAS THEN RECONNECTED TO MECHANICAL VENTILATION USING AN ASTRAL 150 VENTILATOR WITH THE CUFF INFLATED WITH 8 ML OF STERILE WATER (PPI). AT 16:00, THE PATIENT PRESENTED A DECREASE IN TIDAL VOLUME, AN INCREASE IN RESPIRATORY RATE, AND SWEATING. TRACHEOBRONCHIAL SUCTIONING COULD NOT BE PROPERLY PERFORMED BECAUSE THE SUCTION CATHETER COULD NOT ADVANCE BEYOND 15 CM FROM THE TRACHEAL OPENING. AN AEROSOL TREATMENT WAS PERFORMED, AFTER WHICH SIGNIFICANT LEAKS APPEARED ON THE ASTRAL 150 VENTILATOR. THE VENTILATOR WAS THEREFORE REPLACED WITH ANOTHER MODEL (DRÄGER). CLINICAL CONSEQUENCES: THE PATIENT EXPERIENCED OXYGEN DESATURATION REQUIRING AN URGENT BRONCHOSCOPY PERFORMED UNDER SEDATION AND VASOPRESSOR SUPPORT. THE PHYSICIAN OBSERVED A PROGRESSIVE REDUCTION OF THE CANNULA LUMEN AS T

  Patient problems: Hypoxia; Increased Respiratory Rate

  MAUDE report 24790159 ↗
• MalfunctionMar 2, 2026Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483126 ↗
• InjuryFeb 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT DEPENDENT ON A VENTILATOR AND WITH A TRACHEOSTOMY TUBE INSERTED APPROXIMATELY 3 DAYS PRIOR, PRESENTED WITH A SUDDEN DETERIORATION IN RESPIRATORY FUNCTION (RESPIRATORY DISTRESS) REQUIRING HIGHER PRESSURES. ON ARRIVAL, THE RT ASSESSED THE TRACHEOSTOMY CUFF AND NOTED IT WAS COMPLETELY DEFLATED. APPROXIMATELY 10¿12 ML OF STERILE WATER WAS INSTILLED INTO THE CUFF. WITHIN 10 SECONDS, THE PILOT BALLOON COMPLETELY DEFLATED, WITH MEASURED CUFF PRESSURE OF 0 CMH2O. SIMULTANEOUSLY, VENTILATOR LEAK INCREASED TO 70 L PER MIN, AND EXHALED TIDAL VOLUMES DECREASED TO APPROXIMATELY 50 ML PER BREATH, COMPARED TO THE PREVIOUSLY EXPECTED 450 ML. A TRACHEOSTOMY TUBE CHANGE WAS PERFORMED IN THE ER. FOLLOWING REMOVAL, THE ORIGINAL TRACHEOSTOMY TUBE WAS TESTED FOR INTEGRITY. UPON INSTILLATION OF STERILE WATER INTO THE CUFF, WATER WAS OBSERVED SQUIRTING FROM THE CUFF, CONFIRMING A CUFF DEFECT. TACHYPNEA, DESATURATION, MARKED INCREASE IN VENTILATORY PRESSURES, SIGNIFICANT VENTILATOR LEAK, AND A MARKED DECREASE IN TIDAL VOLUME, MEASURED AT APPROXIMATELY 50 ML COMPARED TO 450 ML. A NEW BIVONA TRACHEOSTOMY TUBE WAS INSERTED. A CHEST X-RAY AND CT SCAN WERE PERFORMED. THERE WAS A P

  Patient problems: Increased Respiratory Rate

  MAUDE report 24278811 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE FIRST TRACHEOSTOMY TUBE WAS PLACED AND SHOWED LEAKAGE AFTER 17 DAYS OF USE WITH A PATIENT. THE INCIDENT OCCURRED AT THE PATIENT¿S HOME AND WAS HANDLED BY A HEALTHCARE PROFESSIONAL. THE ISSUE WAS RESOLVED BY REPLACING THE TUBE WITH A NEW ONE. A SAMPLE PHOTO PROVIDED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958630 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SECOND TRACHEOSTOMY TUBE WAS PLACED AND SHOWED LEAKAGE AFTER 13 DAYS OF USE WITH A PATIENT. THE INCIDENT OCCURRED AT THE PATIENT¿S HOME AND WAS MANAGED BY A HEALTHCARE PROFESSIONAL. THE ISSUE WAS RESOLVED BY REPLACING THE TUBE WITH A NEW ONE. A SAMPLE PHOTO PROVIDED. THERE WAS A PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939978 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FIRST TRACHEOSTOMY TUBE WAS PLACED AND SHOWED LEAKAGE AFTER 17 DAYS OF USE WITH A PATIENT. THE INCIDENT OCCURRED AT THE PATIENT¿S HOME AND WAS HANDLED BY A HEALTHCARE PROFESSIONAL. THE ISSUE WAS RESOLVED BY REPLACING THE TUBE WITH A NEW ONE. A SAMPLE PHOTO PROVIDED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939537 ↗
• MalfunctionJun 24, 2025Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT THE CLINICIAN REMOVED THE PLUG AND PUT CUFF UP WITH 7 ML OF STERILE WATER. COUGH ASSIST WAS PROVIDED THEN THE ASSIST CLINICIAN REALIZED THAT THEY WERE SUCTIONING WATER OUT OF THE PATIENT AIRWAY. PATIENT WAS SUCTIONED AN ADDITIONAL TIME FOR MINIMAL SECRETIONS AND OR WATER. THE CUFF WAS PUT DOWN AND LESS THAN 1 ML WAS REMOVED FROM CUFF FOR IT TO BE DEFLATED. PATIENT EXPERIENCED NO RESPIRATORY DISTRESS AND DID NOT REQUIRE CUFF TO BE CONTINUALLY UP; THE REASON THE CUFF WAS UP MOMENTARILY, WAS FOR THE MORE EFFECTIVE ADMINISTRATION OF COUGH ASSIST. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323001 ↗
• MalfunctionApr 24, 2025Failure to Deflate; Failure to Deflate

  THE REPORTER STATED THAT THE PATIENT CHANGED THE CANNULA DAILY BECAUSE HE USED A SILVER CANNULA DURING THE DAY. AFTER ABOUT 3 WEEKS HE COULD NO LONGER DEPRESS THE VALVE WITH THE SYRINGE, WHICH MEANS HE COULD NO LONGER DEFLATE THE CUFF OF THE CANNULA. THERE WAS PATIENT INVOLVEMENT AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899327 ↗
• MalfunctionApr 24, 2025Failure to Deflate; Failure to Deflate

  THE REPORTER STATED THAT THE PATIENT CHANGED THE CANNULA DAILY BECAUSE HE USED A SILVER CANNULA DURING THE DAY. AFTER ABOUT 3 WEEKS HE COULD NO LONGER DEPRESS THE VALVE WITH THE SYRINGE, WHICH MEANS HE COULD NO LONGER DEFLATE THE CUFF OF THE CANNULA. THERE WAS PATIENT INVOLVEMENT AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899274 ↗
• MalfunctionApr 24, 2025Failure to Deflate; Failure to Deflate

  THE REPORTER STATED THAT THE PATIENT CHANGED THE CANNULA DAILY BECAUSE HE USED A SILVER CANNULA DURING THE DAY. AFTER ABOUT 3 WEEKS HE COULD NO LONGER DEPRESS THE VALVE WITH THE SYRINGE, WHICH MEANS HE COULD NO LONGER DEFLATE THE CUFF OF THE CANNULA. THERE WAS PATIENT INVOLVEMENT AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899237 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT THE PILOT BALLOON SEEMED TO HAVE A TEAR IN LINE ON WHERE THE PILOT BALLOON IS CONNECTED TO THE FLANGE. DUE TO THIS, IT WAS REPORTED THAT THE CUFF COULD NOT INFLATE PROPERLY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT HOME AFTER TRACH HAS BEEN USED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE NO PATIENT HARM/ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668282 ↗
• InjuryAug 5, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A LEAKY CUFF EVENT. X-RAY DESCRIPTION WAS: "NEW LEFT-SIDED LOWER LOBE ATELECTASIS AND GENERAL BLURRING OF THE LEFT HEMITHORAX AND THERE MAY BE NEW PLEURAL FLUID ON THE LEFT SIDE." POTENTIAL LOT NUMBER: 4395734 OR 4400617.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905559 ↗
• MalfunctionJun 17, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE DEVICE DID NOT COME WITH A BALLOON IN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547245 ↗
• MalfunctionAug 21, 2023Material Rupture; Contamination of Device Ingredient or Reagent; Material Rupture; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE TRACH TUBE BALLOON BURST. THE CUSTOMER STATES THERE WAS ALSO A PIECE OF HAIR INSIDE THE TRACH TUBE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17591897 ↗
• MalfunctionFeb 8, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT EVERY TIME THE TRACHEOSTOMY IS RECEIVED BACK FROM CLEANING OR TO GO TO CLEANING SECRETIONS ARE FOUND ON THE TRACH. THE PATIENT HAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND MANY SECRETIONS GET ENCRUSTED ON THE TRACHEOSTOMY. THIS HAS BEEN SEEN AT LEAST 3 OR 4 TIMES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325428 ↗
• MalfunctionFeb 7, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT EVERY TIME THE TRACHEOSTOMY IS RECEIVED BACK FROM CLEANING OR TO GO TO CLEANING, SECRETIONS ARE FOUND ON THE TRACH. THE PATIENT HAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND MANY SECRETIONS GET ENCRUSTED ON THE TRACHEOSTOMY. THIS HAS BEEN SEEN AT LEAST 3 OR 4 TIMES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316262 ↗
• MalfunctionFeb 7, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT EVERY TIME THE TRACHEOSTOMY IS RECEIVED BACK FROM CLEANING OR TO GO TO CLEANING, SECRETIONS ARE FOUND ON THE TRACH. THE PATIENT HAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND MANY SECRETIONS GET ENCRUSTED ON THE TRACHEOSTOMY. THIS HAS BEEN SEEN AT LEAST 3 OR 4 TIMES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316126 ↗
• MalfunctionFeb 7, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT EVERY TIME THE TRACHEOSTOMY IS RECEIVED BACK FROM CLEANING OR TO GO TO CLEANING, SECRETIONS ARE FOUND ON THE TRACH. THE PATIENT HAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND MANY SECRETIONS GET ENCRUSTED ON THE TRACHEOSTOMY. THIS HAS BEEN SEEN AT LEAST 3 OR 4 TIMES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316109 ↗
• InjuryJan 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT .4 TRACHS HAVE STARTED TO LEAK WHILE IN USE WITH THE PATIENT. THE TRACH WOULD LAST FOR A VARIOUS AMOUNT OF DAYS BEFORE STARTING TO LEAK RANGING FROM 2-10 DAYS. THIS IS CAUSING CONCERN FOR THE CUSTOMERS AND THEY FEEL UNSAFE USING THE DEVICES. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210786 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO INSERTION WITH A NEW CUFF, CUFF BALLOON SILICONE LIFTED AWAY FROM WHERE SYRINGE IS INSERTED INTO. SILICONE WILL NOT GO BACK INTO PLACE. NO INJURY WAS REPORTED; NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521647 ↗
• InjurySep 2, 2022Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE CUSTOMER HAS HAD TO CHANGE OUT SEVERAL TRACH TUBES DUE TO THEM HAVING LEAKS. WHEN CHECKED, AFTER THE TRACH CHANGE WAS COMPLETED, THE CUFFS WERE NOTED TO HAVE PIN SIZE HOLES IN THEM. CAUSING THE PATIENT TO LOOSE VOLUME WHILE ON THE VENTILATOR. NO INJURY OR ADVERSE AFFECTS AFTER TRACH CHANGE WAS COMPLETED.

  Patient problems: Decreased Respiratory Rate; Forced Expiratory Volume Decreased

  MAUDE report 15353086 ↗