Bivona 67P040Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 15021312006278), received between Mar 26, 2018 and Dec 22, 2025 — classified as 12 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (27 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 29, 2024Open, Classified

   Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

   Z-2610-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT STAFF NOTED DURING A TRACH TIE CHANGE THAT THE LEFT SIDE FLANGE HAD A TEAR AT THE BASE WHERE IT CONNECTS TO THE MAIN TRACH. AN EMERGENCY TRACH CHANGE WAS COMPLETED. THERE WERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863240 ↗
• MalfunctionMay 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON COULD NOT SEEM TO BE INFLATED COMPLETELY. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005940 ↗
• MalfunctionMar 25, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH WOULD NOT INFLATE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691046 ↗
• MalfunctionMar 17, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON COULD NOT SEEM TO BE INFLATED COMPLETELY. THERE WERE UNKNOW PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21623741 ↗
• InjuryDec 30, 2024Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE A HIGH LEAK ON VENTILATION. PREVIOUS INCIDENTS WERE NOTED WHERE THE CUFF WAS NOT INFLATING EFFECTIVELY. AGREED TO DO PLANNED TUBE CHANGE WHERE NEW TUBE HAS THE CUFF CHECKED AND CONFIRMED TO BE WORKING PROPERLY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036578 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SERIOUS COMPLICATION OCCURRED WITH THE BIVONA TRACHEOSTOMY TUBE WHEN THE PATIENT PERFORMED DECANNULATION, AND THE PATIENT ALMOST LOST HER LIFE. EVEN THOUGH IT APPEARED THAT THE BALLOON WAS INFLATED, IT DEFLATED AND THE PATIENT DECANNULATED. THE CANNULA DISLOCATED, AND IT WAS ONLY NOTICED AT THE MOMENT THAT THE PATIENT BEGAN TO PRESENT RESPIRATORY DISCOMFORT, DEFLATING QUICKLY, DEVELOPING TO DESATURATION. WHEN IT WAS NOTICED THAT THE CANNULA HAD COME OUT, THE MOTHER REPLACED THE CANNULA QUICKLY. WITH THE AID OF THE AMBULANCE AND OXYGEN THEY WENT TO THE HOSPITAL. PATIENT WAS ON CARDIORESPIRATORY ARREST ABOUT 5 MINUTES, AND 7 MINUTES INTO THE HOSPITAL DOING RESUSCITATION MANEUVERS, ALSO HAD PERI TRACHEOSTOMY BLEEDING. WHEN DECANNULATION WAS OBSERVED IN THE TRACHEA, THE HEALTH PROFESSIONALS IMMEDIATELY CHANGED THE CANNULA. RIGHT AFTER THE PATIENT PRESENTED GASPING; HOWEVER, SHE IMPROVED AFTER SUCTION OF A GREAT AMOUNT OF SECRETION DURING PHYSIOTHERAPY CARE. THE PATIENT WAS ADMITTED IN THE HOSPITAL, ALREADY ON A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) MACHINE WITH GOOD SATURATION, ADEQUATE PERFUSION, AND AGITATED. THIS WAS THE SECOND TIME SHE HAS HAD THIS SAME PR

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 20641301 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SERIOUS COMPLICATION OCCURRED WITH THE BIVONA TRACHEOSTOMY TUBE WHEN THE PATIENT PERFORMED DECANNULATION, AND THE PATIENT ALMOST LOST HER LIFE. EVEN THOUGH IT APPEARED THAT THE BALLOON WAS INFLATED, IT DEFLATED AND THE PATIENT DECANNULATED. THE CANNULA DISLOCATED, AND IT WAS ONLY NOTICED AT THE MOMENT THAT THE PATIENT BEGAN TO PRESENT RESPIRATORY DISCOMFORT, DEFLATING QUICKLY, DEVELOPING TO DESATURATION. WHEN IT WAS NOTICED THAT THE CANNULA HAD COME OUT, THE MOTHER REPLACED THE CANNULA QUICKLY. WITH THE AID OF THE AMBULANCE AND OXYGEN THEY WENT TO THE HOSPITAL. PATIENT WAS ON CARDIORESPIRATORY ARREST ABOUT 5 MINUTES, AND 7 MINUTES INTO THE HOSPITAL DOING RESUSCITATION MANEUVERS, ALSO HAD PERI TRACHEOSTOMY BLEEDING. WHEN DECANNULATION WAS OBSERVED IN THE TRACHEA, THE HEALTH PROFESSIONALS IMMEDIATELY CHANGED THE CANNULA. RIGHT AFTER THE PATIENT PRESENTED GASPING; HOWEVER, SHE IMPROVED AFTER SUCTION OF A GREAT AMOUNT OF SECRETION DURING PHYSIOTHERAPY CARE. THE PATIENT WAS ADMITTED IN THE HOSPITAL, ALREADY ON A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) MACHINE WITH GOOD SATURATION, ADEQUATE PERFUSION, AND AGITATED. THIS WAS THE SECOND TIME SHE HAS HAD THIS SAME PR

  Patient problems: Cardiac Arrest; Decreased Respiratory Rate; Discomfort; Hemorrhage/Blood Loss/Bleeding; Low Oxygen Saturation; Respiratory Arrest

  MAUDE report 20641290 ↗
• MalfunctionOct 17, 2024Break; Break

  IT WAS REPORTED THAT THE PILOT BALLOON PRESENTED A BREAK. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474706 ↗
• MalfunctionOct 8, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CANNULA'S CUFF PRESENTED A MISSHAPEN INFLATION, CAUSING IT TO BE POORLY POSITIONED IN THE TRACHEAL LUMEN, MAKING VENTILATION DIFFICULT. IT WAS REPORTED THAT THE ANTERIOR PART OF THE PRODUCT IS INFLATING MORE THAN THE POSTERIOR PART, DEFLECTING THE CANNULA AND HITTING THE TRACHEA WALL, WHICH IS WHY THE PATIENT IS NOT VENTILATING, THE PRODUCT IS GLUED ON ITS POSTERIOR FACE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398278 ↗
• MalfunctionNov 1, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A NEW TRACH TUBE WAS USED. PROBLEM OCCURRED ON TEST OF THE BALLOON PRIOR TO PATIENT CONTACT. THE BALLOONS OF THESE TRACHS COMES OUT OF THE PACKAGE VACUUM SEALED. IT TAKES A LOT OF MANIPULATION TO GET THEM FREE TO INFLATE PROPERLY. NO PATIENT INVOLVEMENT. NO PATIENT OR CLINICAL INJURY. NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048526 ↗
• InjuryAug 14, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE A HIGH LEAK ON VENTILATION. UPON REMOVING THE TUBE, IT WAS FOUND THAT THE CUFF WAS NOT INFLATING AT ALL AND REQUIRED A LOT OF MANIPULATION TO GET IT WORKING. A TUBE CHANGE TOOK PLACE, DURING WHICH THE NEW TUBE'S CUFF WAS CHECKED AND CONFIRMED TO BE WORKING PROPERLY. ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17542456 ↗
• MalfunctionMay 5, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING CUFF TESTING BEFORE USE, CUFF WOULD NOT COMPLETELY INFLATE. CUFF WAS MANIPULATED JUST AS STATED IN PRODUCT'S INSTRUCTIONS FOR USE BUT ISSUE WAS NOT RESOLVED. USE OF ANOTHER TRACHEOSTOMY TUBE TO RESOLVE ISSUE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882727 ↗
• InjuryMar 23, 2023Deflation Problem; Overfill; Failure to Deflate; Deflation Problem; Overfill; Failure to Deflate

  IT WAS REPORTED THAT WHEN ATTEMPTING TO DEFLATE THE CUFF OF THE TRACHEOSTOMY TUBE, IT TOOK 3-4 ATTEMPTS TO GET ALL THE WATER OUT. ONLY 2ML OF THE 2.4ML THAT WAS USED TO INFLATE BALLOON WAS ABLE TO BE TAKEN OUT. A TRACH CHANGE WAS DONE TO DETERMINE WHAT THE ISSUE WAS. THE PILOT BALLOON WAS COMPLETELY DEFLATED AND WHEN THE TUBE WAS TAKEN OUT THE CUFF WAS FOUND OVERINFLATED. PULLING THE TRACH TUBE OUT IN THE INFLATED STATE CAUSED BLEEDING. THE PATIENT WAS TAKEN TO THE HOSPITAL FOR OBSERVATION TO MAKE SURE THERE WAS NO DAMAGE TO THE AIRWAY. THIS IS NOT THE FIRST OF THIS TYPE OF ISSUE. THERE HAVE BEEN 5 SUCH ISSUES WITH THIS ONE LEADING TO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16602015 ↗
• InjuryJan 9, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT TRACH CHANGED FROM UNCUFFED TO THE CUFFED. POST TRACH CHANGE PATIENT HAD BEEN LESS STABLE THAT SHIFT. HAD ISSUES WITH ONGOING INTERMITTENT LEAK POST TRACH CHANGE TO THE CUFFED TRACH AND ONGOING WORSENING VENTILATION STATUS. TRACH CHANGED AND UPON INSPECTION AFTER REMOVAL, CUFF FOUND TO BE UNEVENLY INFLATED. CUFF REMAINED FULL ATTACHED FULL LENGTH ON ONE SIDE OF TRACH TUBE. RRT HAD PUT 5 ML OF STERILE WATER INTO CUFF PRE- TRACH CHANGE AND CUFF APPEARED TO FULLY INFLATE BUT STATES DID NOT APPRECIATE THAT THE CUFF WAS NOT DETACHED ON THE ONE SPOT. THE LEVEL OF HARM WAS MINIMAL HARM. THE IMPACT OF INCIDENT WAS VENTILATION AND OXYGENATION AND WOB (WORK OF BREATHING) ALL POTENTIALLY NEGATIVELY IMPACTED DUE TO INEFFECTIVE CUFF SEAL AND CAUSED THE REQUIREMENT FOR AN ADDITIONAL TRACH CHANGE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16124452 ↗
• MalfunctionDec 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT FULLY INFLATING DESPITE MANIPULATIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052527 ↗
• MalfunctionSep 7, 2022Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT THE CUFF HAD A SLIGHT ASYMMETRY AFTER INFLATION, EVEN AFTER TESTING WITH WATER AND AFTER MASSAGING THE CUFF AS RECOMMENDED IN THE INSTRUCTIONS FOR USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374585 ↗
• MalfunctionSep 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THE CUFF WAS NOT INFLATING PROPERLY, ADHERED TO TUBE ON ONE SIDE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363890 ↗
• InjuryJul 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED VIA MEDWATCH NUMBER (B)(4). THE CUSTOMER WAS PERFORMING A TRACH CHANGE AT BEDSIDE TODAY. THE REPLACEMENT TRACH WAS NEW OUT OF THE PACKAGE. THE BALLOON DIDN'T INFLATE, CAUSING PATIENT TO NOT PROPERLY VENTILATE WHILE ON THE VENT. THEY HAD NO OTHER BIVONA 4 AND HAD TO PUT IN A BIVONA 3.5 INSTEAD. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 07-JUL-2022: ACCORDING TO THE EVENT REPORT WE RECEIVED, THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THE PRODUCT MALFUNCTION. RESPONDENT HAS REACHED OUT TO SUPPLY CHAIN DEPARTMENT TO SEE IF THE PRODUCT WAS SENT BACK TO THE MANUFACTURER AND WILL RESPOND AGAIN WHEN THEY HEAR BACK.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15076750 ↗
• InjuryApr 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE DESPITE FOLLOWING THE INSTRUCTIONS FOR USE. NO CLINICAL CONSEQUENCE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219758 ↗
• InjuryApr 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THECUFF WOULD NOT INFLATE DESPITE FOLLOWING THE INSTRUCTIONS FOR USE. NO CLINICAL CONSEQUENCE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219684 ↗
• MalfunctionApr 12, 2022Inflation Problem; Inflation Problem

  CUFF DOES NOT INFLATE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083923 ↗
• MalfunctionJan 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THE ITEM WOULD NOT INFLATE WHEN CUSTOMER TOOK IT OUT OF THE BOX TO PLACE THE OLD TRACH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177820 ↗
• MalfunctionJan 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THE ITEM WOULD NOT INFLATE WHEN CUSTOMER TOOK IT OUT OF THE BOX TO PLACE THE OLD TRACH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177116 ↗
• MalfunctionJan 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THE ITEM WOULD NOT INFLATE WHEN CUSTOMER TOOK IT OUT OF THE BOX TO PLACE THE OLD TRACH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176779 ↗
• MalfunctionOct 15, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE THAT WILL NOT FULLY INFLATE DESPITE MANIPULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642260 ↗