Bivona 67P035Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 15021312006261), received between Mar 21, 2018 and Jun 19, 2025 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (14 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE DURING A TRACHEOSTOMY TUBE CHANGE FOR A CHILD. THE REPORTER NOTED THAT THE CHANGE WAS PERFORMED BY A PARENT AT THE MOMENT OF CHECKING THE PROPER FUNCTIONING OF THE BIVONA TUBE CUFF. DESPITE THE PARENT MANIPULATING THE END OF THE TUBE, WHERE THE CUFF WAS LOCATED, THE CUFF DID NOT INFLATE. THE REPORTER TOOK OVER AND ATTEMPTED SEVERAL TIMES, AFTER KNEADING THE TUBE AND INCREASING THE INFLATION VOLUME, BUT THERE WAS NOTHING TO REPORT (RAS). IT BECAME NECESSARY TO USE ANOTHER TUBE, WITH WHICH THE PARENT ENCOUNTERED THE SAME DIFFICULTY. THE REPORTER PERSISTED FOR A GOOD FIVE MINUTES, AND EVENTUALLY, THE CUFF DID INFLATE. BEFORE INSERTING THE TUBE, IT WAS NECESSARY TO KNEAD THE CUFF TO ENSURE IT WAS EVENLY SHAPED. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292780 ↗
• MalfunctionJun 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE DURING A TRACHEOSTOMY TUBE CHANGE FOR A CHILD. THE REPORTER NOTED THAT THE CHANGE WAS PERFORMED BY A PARENT AT THE MOMENT OF CHECKING THE PROPER FUNCTIONING OF THE BIVONA TUBE CUFF. DESPITE THE PARENT MANIPULATING THE END OF THE TUBE, WHERE THE CUFF WAS LOCATED, THE CUFF DID NOT INFLATE. THE REPORTER TOOK OVER AND ATTEMPTED SEVERAL TIMES, AFTER KNEADING THE TUBE AND INCREASING THE INFLATION VOLUME, BUT THERE WAS NOTHING TO REPORT (RAS). IT BECAME NECESSARY TO USE ANOTHER TUBE, WITH WHICH THE PARENT ENCOUNTERED THE SAME DIFFICULTY. THE REPORTER PERSISTED FOR A GOOD FIVE MINUTES, AND EVENTUALLY, THE CUFF DID INFLATE. BEFORE INSERTING THE TUBE, IT WAS NECESSARY TO KNEAD THE CUFF TO ENSURE IT WAS EVENLY SHAPED. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292615 ↗
• MalfunctionFeb 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF ON TRACH WAS LEAKING, E DEFECTIVE TRACH AND NEW TRACH WAS PLACED IN PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469228 ↗
• MalfunctionDec 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS DEFECTIVE AND DID NOT COMPLETELY ENCIRCLE THE TUBE/STUCK TO ONE SIDE OF THE TUBE. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT USE. THE EVENT OCCURRED DURING TESTING OF THE CUFF. THERE WAS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833658 ↗
• MalfunctionMay 11, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, THE CUFF DID NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911533 ↗
• MalfunctionNov 4, 2022Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTS TWO DEFECTIVE TRACHEOSTOMY TUBES: THE CUFF DIDN'T INFLATE IN ONE CASE AND IT PARTIALLY INFLATED THEN DEFLATED IN THE OTHER. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734910 ↗
• MalfunctionNov 4, 2022Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTS TWO DEFECTIVE TRACHEOSTOMY TUBES: THE CUFF DID NOT INFLATE IN ONE CASE AND IT PARTIALLY INFLATED THEN DEFLATED IN THE OTHER. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15733968 ↗
• MalfunctionSep 30, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE USER WAS UNABLE TO PROPERLY INFLATE CUFF DURING ROUTINE TRACH CHANGE. NO MEDICAL INTERVENTION; NEW TRACH PLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521780 ↗
• MalfunctionSep 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO TRACH CUFFS WERE NOT INFLATING PROPERLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492308 ↗
• MalfunctionSep 19, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT DURING TESTING, THE BALLOON OF THE TRACH TUBE DID NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446765 ↗
• MalfunctionSep 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, ONLY THE BALLOON WAS FOUND TO BE INFLATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433242 ↗
• InjuryJul 27, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE TRACHEOSTOMY TUBES ON ONE OF THEIR PEDIATRIC PATIENTS. THE PATIENT DID HAVE AN ISSUE WITH DESATURATION AND THEIR TRACHEOSTOMY TUBE NEEDED TO BE CHANGED OUT. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL DATED ON (B)(6) 2022: THE CUFF DID NOT SEAL WITH PLACEMENT OF STERILE WATER, LARGE LEAK NOTED, DECOMPENSATION. NURSE WAS CALLED TO BEDSIDE, COULD HEAR INFANT CRYING WITH DECOMPENSATION, ADDED 1 CC OF STERILE WATER AND THERE WAS NO EFFECT, CHANGED OUT TO ANOTHER SIZE TRACHEOTOMY TUBE. PREMATURELY NEEDED TO CHANGE TRACHEOSTOMY TUBE UNTIL WE HAD A GOOD SEAL WITH CUFF AND NO LEAK AND NO DECOMPENSATION, GOOD BILATERAL BREATH SOUNDS.

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 15116986 ↗
• MalfunctionOct 6, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THE DEVICE'S CUFF WAS NOT INFLATING DURING PRE-TEST DESPITE FILLING WITH WATER. NO ADVERSE EFFECTS REPORTED AS A RESULT OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587300 ↗
• MalfunctionJan 13, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THE DEVICE CUFF WOULD NOT INFLATE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11167297 ↗
• MalfunctionNov 21, 2020Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BALLOON DOES NOT INFLATE ON THE BIVONA TUBE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Information

  MAUDE report 10880946 ↗
• MalfunctionNov 21, 2020Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BALLOON DOES NOT INFLATE ON THE BIVONA TUBE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Information

  MAUDE report 10880938 ↗
• MalfunctionNov 21, 2020Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BALLOON DOES NOT INFLATE ON THE BIVONA TUBE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Information

  MAUDE report 10880927 ↗
• MalfunctionNov 21, 2020Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BALLOON DOES NOT INFLATE ON THE BIVONA TUBE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Information

  MAUDE report 10880921 ↗
• MalfunctionNov 21, 2020Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BALLOON DOES NOT INFLATE ON THE BIVONA TUBE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Information

  MAUDE report 10880907 ↗
• InjuryNov 15, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SMITHS MEDICAL TRACH TUBE WAS NOT HOLDING WATER. FILLED BALLOON WITH 1.5 ML OF STERILE WATER. MOM REPORTS CHECKING CUFF 4 HOURS LATER AND THE CUFF IS LOSING ABOUT 0.5 ML. SHE TRIED IT MULTIPLE TIMES. TRACH WAS IN USE FOR 2 DAYS. A TRACH CHANGE WAS NEEDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10841716 ↗
• MalfunctionSep 24, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION WAS RECEIVED INDICATING THAT THE BIVONA TRACHEOSTOMY TUBE HAD BE CHANGED. IT WAS REPORTED THAT THE VENTILATOR ALARMED AND DURING TROUBLE SHOOTING THE TUBE DECANNULATED. WHEN THE SYRINGE WAS REMOVED THE CUFF DEFLATED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10582842 ↗
• MalfunctionSep 20, 2020Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE APPEARS TO HAVE GROWN MOLD INSIDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10558307 ↗
• InjuryJan 24, 2020Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITH MEDICAL SILICONE - BIVONA TUBES NEO/PED TTS WOULD NOT INFLATE. THE PHYSICIAN REPORTS THAT WAS A TRACH WAS BROUGHT TO THE BEDSIDE FOR A LAST RESORTED EFFORT TO VENTILATE A PATIENT THAT WAS IN RESPIRATORY FAILURE. THE PATIENT HAD A LEAK IN HER EXISTING TUBE THAT WAS NOT A SMITHS MEDICAL PRODUCT. THIS WAS AN EMERGENT TRACHEOSTOMY CHANGE THAT IS BEING DESCRIBED. THREE PROVIDERS WERE NOT ABLE TO INFLATE THE BALLOON. FIFTEEN MINUTES ELAPSED AND USED HIGHER PRESSURE TO INFLATE BALLOON, WHICH WAS AT RISK FOR RUPTURE. THIS INTERVENTION DONE BY ENT TEAM MEMBER WAS SUCCESSFUL. THE REPORT INDICATES THE PATIENT WAS HIGH RISK FOR FAILED RESPIRATORY INTERVENTION, WHICH WOULD LEAD TO DEATH, AS COMPROMISED AIRWAY, BREATHING AND CIRCULATION WERE DESCRIBED AND REPORT IS CONSIDERED SERIOUS INJURY REPORTABLE. THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION, AS THE DEVICE CAN NOT BE RETURNED IN FAILED CONDITION ACCORDING TO PROVIDER.

  Patient problems: Respiratory Distress Syndrome of Newborns

  MAUDE report 9629315 ↗
• MalfunctionSep 17, 2019Material Discolored; Inflation Problem; Material Discolored; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING A ROUTINE CHANGE OUT OF A SMITHS MEDICAL PORTEX® BIVONA® TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE DISCOLORATION OF THE FLANGE WAS OBSERVED. IT WAS REPORTED BY THE NURSE THAT DISCOLORATION (LIGHT YELLOW - ORANGE) ON INNER ASPECT OF THE FLANGES WAS NOTED. TWO TRACH TUBES WERE NOTED AT BEDSIDE; ONE WITH SAME DISCOLORATION AND ONE WITHOUT. THE PATIENT HAD BEEN REPORTED TO BE UNDERGOING PROTON THERAPY IN MRI. SUBSEQUENTLY, THE REPLACEMENT TUBE WAS REPORTED TO NOT INFLATE PROPERLY WITH STERILE WATER DURING PRE-TEST; ONLY 2/3 AROUND THE SHAFT INFLATED. MASSAGING OF THE CUFF WAS PERFORMED WITHOUT SUCCESS. A TUBE WAS FINALLY PLACED WITH NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9077775 ↗
• MalfunctionJun 11, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE INSERTION OF THE TRACHEOSTOMY TUBE, THE NURSE NOTICED THAT THE CUFF DID NOT INFLATE. THE CUFF REMAINED STUCK TO THE CANNULA. THE PRODUCT WAS THEREFORE NOT USEABLE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689870 ↗