Bivona 670170Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 15021312006056), received between Feb 8, 2017 and Sep 30, 2026 — classified as 10 deaths, 52 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (41 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-2588-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951802 ↗
• MalfunctionApr 28, 2026Gas/Air Leak

  IT WAS STATED THAT LEAKAGE WAS IDENTIFIED ON THE THIRD DAY OF USE WHILE THE DEVICE WAS IN USE WITH A PATIENT. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER BRAND. THE EVENT OCCURRED IN A HOSPITAL AND WAS HANDLED BY A HEALTH PROFESSIONAL. THE OUTCOME WAS RESOLVED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015556 ↗
• MalfunctionApr 7, 2026Deflation Problem

  IT WAS STATED THAT AFTER 29 DAYS OF USE, AN ATTEMPT WAS MADE TO REMOVE THE TRACHEOSTOMY TUBE. CUFF DEFLATION WAS DIFFICULT, AND ONLY 2 CC OF WATER WAS WITHDRAWN. THE TUBE WAS SLOWLY REMOVED WHILE THE CUFF REMAINED INFLATED. SUBSEQUENT TESTING CONFIRMED THAT THE CUFF COULD NEITHER BE DEFLATED NOR INFLATED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802263 ↗
• MalfunctionFeb 26, 2026Gas/Air Leak

  THE PATIENT BEGAN TO EXPERIENCE INCREASED WORK OF BREATHING DUE TO A LARGE LEAK, BUT ONCE THE NEW DEVICE WAS INSERTED, THE PATIENT'S CONDITION STABILIZED. NO INCREASE IN OXYGEN OR OTHER MANEUVERS WAS NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465465 ↗
• MalfunctionMay 28, 2025Contamination; Contamination

  IT WAS REPORTED THAT THERE WERE ISSUES WITH RESIDUE WITHIN THE CUFF AFTER REPROCESSING TRACH. IT WAS VERIFIED WITH THE PATIENT THAT THE STERILE WATER IN THE CUFF WAS BEING USED, AND PROPER TECHNIQUE WAS BEING FOLLOWED. THE REPORTER TRIED TO FLUSH IT OUT OF THE TRACHEOSTOMY TUBE, BUT SMALL AMOUNT REMAINED. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096707 ↗
• MalfunctionMay 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE TUBE CUFF COULD NOT BE DEFLATED, AND THE WATER COULD NOT BE REMOVED. THE NURSE CUT THE INFLATION LINE, INSERTED A NEEDLE INTO IT, AND GRADUALLY ASPIRATED THE CUFF'S CONTENTS. THE EVENT TOOK PLACE AT THE PATIENT'S HOME AND WAS CONDUCTED BY A HEALTH PROFESSIONAL. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079079 ↗
• MalfunctionMay 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND AT THE POINT WHERE CUFF INFLATION TUBE CONNECTS TO SECUREMENT FLANGE AFTER INSERTING IN 1 HR. THE ISSUE WAS RESOLVED AFTER REPLACING A NEW ONE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972492 ↗
• MalfunctionMar 11, 2025Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED THAT CUFF LEAKAGE WAS FOUND AFTER USING THE TRACH ON THE PATIENT FOR ABOUT 2 WEEKS. THE PROBLEM WAS RESOLVED WHEN A NEW TRACH TUBE WAS PLACED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL. THIS WAS REPORTED TO THE FDA. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573134 ↗
• MalfunctionFeb 20, 2025Contamination; Contamination

  IT WAS REPORTED THAT THERE WERE ISSUES WITH RESIDUE WITHIN THE CUFF AFTER REPROCESSING TRACH. IT WAS VERIFIED WITH THE PATIENT THAT THE STERILE WATER IN THE CUFF WAS BEING USED, AND PROPER TECHNIQUE WAS BEING FOLLOWED. THE REPORTER TRIED TO FLUSH IT OUT OF THE TRACHEOSTOMY TUBE, BUT SMALL AMOUNT REMAINED. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428607 ↗
• InjuryDec 6, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT CUFF LEAKAGE WAS FOUND ON THE 10TH DAY OF USING THE TRACHEOSTOMY TUBE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THE PROBLEM WAS RESOLVED BY REPLACING WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860235 ↗
• 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 20833243 ↗
• InjuryNov 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD 4 SEPARATE INCIDENTS OF BLOWN CUFFS ON 4 DIFFERENT #7 BIVONA TRACHEOSTOMY TUBES. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT IN THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS MEDICAL INTERVENTION REQUIRED; 5 TRACH CHANGES IN 48 HOURS, AND THIS WAS NOT REPORTED TO THE FDA. THE ISSUE WAS RESOLVED BY REPLACING THE TRACH WITH A DIFFERENT DEVICE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610340 ↗
• InjuryNov 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD 4 SEPARATE INCIDENTS OF BLOWN CUFFS ON 4 DIFFERENT # 7 BIVONA TRACHEOSTOMY TUBES. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT IN THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS MEDICAL INTERVENTION REQUIRED; 5 TRACH CHANGES IN 48 HOURS, AND THIS WAS NOT REPORTED TO THE FDA. THE ISSUE WAS RESOLVED BY REPLACING THE TRACH WITH A DIFFERENT DEVICE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610339 ↗
• InjuryMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING MECHANISM IN THE PILOT BALLOON FELL OUT. THERE WAS DESATURATION EVENT AND SHORTNESS OF BREATH. THE PATIENT REQUIRED A TRACHEOSTOMY CHANGE.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 19359980 ↗
• MalfunctionApr 10, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE ISO COUPLING WAS TOO SMALL, AND SPEAKING VALVES AND HME CASSETTES WOULD NOT STICK WHEN USING AN INNER CANNULA. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082000 ↗
• InjuryMar 14, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PILOT BALLOON WAS FOUND LEAKING WHILE IN USE WITH PATIENT AFTER USE FOR 19 DAYS. THE PROBLEM WAS SOLVED BY REPLACING A NEW ONE. "NO INJURY" REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908853 ↗
• MalfunctionMar 4, 2024Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT THE CUFF WAS DIFFICULT TO INJECT AND EXTRACT WATER FROM DURING THE PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832588 ↗
• MalfunctionNov 30, 2023Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Missing Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Missing Information

  IT WAS REPORTED THAT "DURING A SUBMISSION OF A TENDER IN DENMARK, THE INCLUDED INSTRUCTIONS FOR USE (IFU) WAS INCOMPLETE AND THE DANISH TRANSLATION WAS MISSING. ADDITIONALLY THE TRANSLATION OF THE PRODUCT NAME CONTAINED A TYPO ON THE LABEL (READS SILICONETRAKEOSTOMITUDE, CORRECT IS SILICONETRAKEOSTOMITUBE)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242014 ↗
• MalfunctionNov 29, 2023Microbial Contamination of Device; Optical Discoloration; Microbial Contamination of Device; Optical Discoloration

  IT WAS REPORTED THAT "MOLD" WAS FORMING IN THE CANNULA. THE EVENT OCCURRED DURING A PERIOD OF USE OF ABOUT ONE WEEK WHEN THE "DISCOLORATION" COULD BE SEEN, EVENT OCCURRED IN THE HOME ENVIRONMENT, AND THE OPERATOR OF THE DEVICE WAS THE PATIENT/RELATIVES. NO PATIENT INJURY OR INTERVENTION WAS REPORTED AND THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231882 ↗
• MalfunctionNov 16, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT IT WAS IMPOSSIBLE FOR THE CAREGIVERS TO DEFLATE THE BALLOON, THE PATIENT "FEELS UNABLE TO BREATHE". THE CAREGIVERS HAD TO CHANGE THE CANULA. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155385 ↗
• InjuryNov 9, 2023Deflation Problem; Inflation Problem; Inadequacy of Device Shape and/or Size; Deflation Problem; Inflation Problem; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF PERFORMED NORMALLY DURING PRE-TEST BUT HAD DIFFICULTY TO INFLATE CUFF WHEN IN USE WITH PATIENT. AFTER REMOVAL, THEY TESTED SEVERAL TIMES AND THERE WERE INTERMITTENT DIFFICULTIES WHEN INJECTING AND WITHDRAWING WATER FROM THE CUFF, ON AND OFF. ASYMMETRIC CUFF WAS OBSERVED WHEN INFLATED. THIS PROBLEM WAS RESOLVED BY REPLACING WITH A NEW ONE. "THEY WERE INFORMED ABOUT THIS ISSUE ON (B)(6) ."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105815 ↗
• MalfunctionMar 29, 2023Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK WAS DISCOVERED WHILE IN USE FOR NINE (9) DAYS WITH PATIENT AFTER THE SIXTH STERILIZATION. THE LEAKAGE WAS CONFIRMED WHEN THE PRODUCT WAS WITHDRAWN FROM PATIENT AND FURTHER TESTED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635847 ↗
• InjuryMar 3, 2023Deflation Problem; Failure to Deflate; Deflation Problem; Failure to Deflate

  IT WAS REPORTED THAT THE CUFF ON THE TRACH WAS VERY DIFFICULT TO DEFLATE. THE ISSUE WAS DISCOVERED BY THE CARETAKERS WHILE TRYING TO DEFLATE THE CUFF. THEY CHANGED THE TRACH TO A BACKUP DEVICE THEY HAD. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16482895 ↗
• InjuryMar 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A CUFF LEAK WAS DISCOVERED WHILE IN USE WITH A PATIENT. LEAKAGE CONFIRMED WHEN PRODUCT WAS WITHDRAWN FROM PATIENT AND FURTHER TESTED. CUSTOMER STATES THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16471489 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CUFF WAS LEAKING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436348 ↗