Bivona 67P055Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 15021312006308), received between Apr 12, 2017 and May 21, 2026 — classified as 9 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (60 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 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Inflation Problem

  IT WAS REPORTED BY THE PATIENT THAT THE TRACHEOSTOMY TUBE WAS INSERTED INTO THE PATIENT; HOWEVER, THE PATIENT WAS UNABLE TO BREATHE IMMEDIATELY AFTER INSERTION. THE TUBE WAS REMOVED PROMPTLY. UPON FURTHER INSPECTION, THE BALLOON CUFF WOULD NOT INFLATE WHEN TESTED. THE DEVICE WAS HANDLED BY THE CAREGIVER. THE DEVICE WAS REPORTED AS FAULTY DIRECTLY OUT OF THE BOX. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246934 ↗
• MalfunctionDec 8, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE AND ALSO STUCK ON THE SHAFT. THE EVENT OCCURRED UPON OPENING AT PATIENT'S HOME. THE OUTCOME OF THE EVENT WAS ON GOING AND AWAITING FOR REPLACEMENT. THE CHILD WAS VENT DEPENDENT AND COULD NOT GET BALLOON TO FULLY INFLATE SO TRIED ADDITIONAL VOLUME OF AIR WHICH THEN CAUSED LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745620 ↗
• MalfunctionAug 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON INSIDE THE TRACH WOULD NOT INFLATE. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT. THE PATIENT'S INITIALS ARE M.S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839850 ↗
• InjuryMay 7, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ONE DEVICE WAS DEFECTIVE. WHEN THE PATIENT ATTEMPTED TO INSERT THE TRACHEOSTOMY TIES INTO THE EYELETS OF THE TRACHEOSTOMY TUBE THEY CRACKED. ALSO, ONE OF THE BALLOONS INSIDE THE TRACHEOSTOMY DID NOT INFLATE. THIS WAS PATIENT INVOLVEMENT, AND THERE WERE NO SIGNS OR SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976236 ↗
• MalfunctionMay 6, 2025Crack; Failure to Infuse; Material Split, Cut or Torn; Crack; Failure to Infuse; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THEY ATTEMPTED TO INSERT THE TRACH TIES INTO THE EYELETS OF THE TRACH TUBE THEY CRACKED. ALSO, ONE OF THE BALLOONS INSIDE THE TRACH DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972725 ↗
• MalfunctionMay 6, 2025Crack; Failure to Infuse; Material Split, Cut or Torn; Crack; Failure to Infuse; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THEY ATTEMPTED TO INSERT THE TRACH TIES INTO THE EYELETS OF THE TRACH TUBE THEY CRACKED. ALSO, ONE OF THE BALLOONS INSIDE THE TRACH DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972724 ↗
• MalfunctionMar 2, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICES CUFF WAS INFLATING ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475720 ↗
• MalfunctionFeb 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TRACH HAS AN ASYMMETRICAL CUFF. DISCOVERED IN THE PATIENT'S HOME PRIOR TO PATIENT USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343204 ↗
• MalfunctionNov 8, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AT THE PATIENTS HOME THE CUSTOM BIVONA PILOT BALLOON WAS FAULTY. PATIENT TRACH WAS CHECKED PRIOR TO INSERTION WITH AIR AND CUFF INFLATED. ONCE INSERTED IN PATIENT AND INFLATED WITH WATER AS PER TTS, IT WAS NOTICED THE PILOT BALLOON WAS HERNIATED AND WATER WAS NOT GETTING TO THE BALLOON. TUBE WAS REMOVED. ON INSPECTION THE PILOT BALLOON WAS NEEDING PRESSURE TO BE APPLIED TO TRAVEL TO THE SHAFT BALLOON. NO PATIENT INJURY REPORTED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755623 ↗
• MalfunctionSep 22, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF CANNOT BE FILLED AND DOESN'T UNFOLD. TRACHEOSTOMY HAS NOT BEEN IN USE BEFORE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469012 ↗
• MalfunctionSep 22, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT, DURING PRE-TEST, THE CUFF WAS NOT INFLATING. FORCE WAS USED TO INFLATE THE CUFF AND DUE TO THIS, THE TRACH WAS NOT USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463534 ↗
• MalfunctionSep 19, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF WAS NOT FULLY INFLATING AFTER BEING FILLED WITH LIQUID. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446262 ↗
• MalfunctionSep 19, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF WAS INFLATING ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445251 ↗
• MalfunctionSep 17, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED BY A NURSE THAT THE CUFF ON THE PATIENT'S NEW TRACHEOSTOMY TUBE WAS DEFECTIVE. THIS EVENT OCCURRED AT THE PATIENT'S HOME DURING PRE-TEST OF THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15443069 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF INFLATED ASYMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417098 ↗
• MalfunctionAug 23, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT OVER THE PAST YEAR, THERE HAVE BEEN MANY INCIDENCES OF THE TUBE NOT INFLATING FULLY. THERE HAVE BEEN REGULAR INSTANCES OF THIS ISSUE WITH 1 OR 2 UNITS OUT OF A BOX OF 10 BEING WITHOUT THE DEFECT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280106 ↗
• MalfunctionAug 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE PRE-TEST, THE CUFF INFLATES ASYMMETRICALLY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202898 ↗
• MalfunctionJun 24, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE CUFF COULD NOT BE FILLED DURING THE PRE-USE CHECK. ADDITIONAL INFORMATION WAS RECEIVED ON THE 19TH OF MAY 2022 STATING THE BALLOON DOESN'T INFLATE PROPERLY. NO PATIENT INJURY OR INVOLVEMENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798797 ↗
• MalfunctionJun 24, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE CUFF COULD NOT BE FILLED DURING THE PRE-USE CHECK. ADDITIONAL INFORMATION WAS RECEIVED ON THE (B)(6) 2022 STATING THE BALLOON DOESN'T INFLATE PROPERLY. NO PATIENT INJURY OR INVOLVEMENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798794 ↗
• MalfunctionJun 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE CUFF COULD NOT BE FILLED DURING THE PRE-USE CHECK. ADDITIONAL INFORMATION WAS RECEIVED ON THE (B)(6) 2022 STATING THE BALLOON DOESN'T INFLATE PROPERLY. NO PATIENT INJURY OR INVOLVEMENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14699288 ↗
• MalfunctionJun 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE CUFF COULD NOT BE FILLED DURING THE PRE-USE CHECK. ADDITIONAL INFORMATION WAS RECEIVED ON THE (B)(6) 2022 STATING THE BALLOON DOESN'T INFLATE PROPERLY. NO PATIENT INJURY OR INVOLVEMENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14698963 ↗
• MalfunctionApr 12, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE CUFF INFLATION TEST, BEFORE PATIENT PLACEMENT: SLIGHTLY ASYMMETRIC CUFF INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14089624 ↗
• InjuryMar 11, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF IS NOT PROPERLY INFLATING OR DEFLATING. THE TUBE WAS USED IN PEDIATRIC PATIENT AND THE ISSUES WITH CUFF WAS FOUND WITHIN 24 HOURS. THE DOCTOR HAS ADVISED TO REPLACE THE TUBE. THE TUBING WAS REPLACED, AND THE PATIENT REMAINED STABLE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13738080 ↗
• MalfunctionMar 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT CUFF DOESN'T INFLATE PROPERLY DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714450 ↗
• MalfunctionFeb 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WAS AN INFLATION ISSUE WITH THE CUFF OF THE TRACHEOSTOMY TUBE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534690 ↗