Bivona 670185Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 15021312006087), received between Aug 11, 2017 and May 5, 2023 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION RECEIVED ON 10-OCT-2023 VIA EMAIL. THE EVENT DATE WAS UPDATED FROM UNKNOWN TO 26-APR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16881423 ↗
• MalfunctionMay 5, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, THAT THE TRACHEOSTOMY TUBE WAS SET AND FOUND LEAKING AFTER 3 DAYS IN USE. THE AIRWAY SURFACE OF THE PATIENT IS CONFIRMED, SMOOTH WHICH CHECKED IN HOSPITAL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16881238 ↗
• MalfunctionApr 13, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE DEVICE HAD CUFF LEAKAGE AFTER 15 DAYS IN USE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16736288 ↗
• MalfunctionMar 16, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A TRACH TUBE HAD BEEN RETURNED THAT WAS USED ONE TIME, AND AFTER CLEANING IT THEY WERE NOT ABLE TO REINSERT AS THE BALLOON WAS HARD TO INFLATE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16559254 ↗
• MalfunctionMar 16, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A TRACH TUBE HAD BEEN RETURNED THAT WAS USED ONE TIME, AND AFTER CLEANING IT THEY WERE NOT ABLE TO REINSERT AS THE BALLOON WAS HARD TO INFLATE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16556853 ↗
• MalfunctionMar 14, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE WAS PURCHASED ON (B)(6) 2022 AND IT WAS USED ONCE. THE CUSTOMER CLEANED IT AND THEN TESTED THE BALLOON. THE BALLOON WAS HARD TO INFLATE. THEY DID NOT REINSERT THIS TRACH BUT OPENED UP A NEW BOX AND REINSERTED A NEW TRACH. THERE HAS BEEN NO REPORT OF PATIENT INJURY, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT AS A RESULT OF THIS PRODUCT MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 16541550 ↗
• InjuryNov 18, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE (TRACH) CHANGED BY NURSE TRACH SPECIALIST ON (B)(6), CLIENT COUGHING. NOTICED PARAMETERS ON VENTILATOR AND THE PILOT OF CUFF DOWN, NO WATER IN BALLOON. MORNING NURSE CAME AND CHANGED TRACH TUBE. CLIENT THREW OUT TRACH. OUTSIDE OF THE TRACH CHANGE NO ADDITIONAL INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827224 ↗
• MalfunctionSep 14, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CUSTOMER HAS THE TRACHEOSTOMY TAKEN OUT AFTER THREE WEEKS OF USE, JUST BEFORE BEING REINSERTED, AND THE BALLOON WAS UNABLE TO INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418135 ↗
• InjuryMay 25, 2022Fluid/Blood Leak; Material Perforation; Fluid/Blood Leak; Material Perforation

  IT WAS REPORTED THAT THE TRACH TUBE'S CUFF WAS FILLED WITH 9ML OF WATER, AND THE USER NOTICED THAT PATIENT WAS CHOKING. USER TRIED TO DRAW THE 9ML FROM THE CUFF, BUT THERE WAS ONLY 3ML. THE CUFF WAS PIERCED. ADDITIONAL INFORMATION RECEIVED: THE PHYSICIAN CHANGED THE TRACH TUBE TO RESOLVE THE SITUATION, IN ADDITION TO COUGH ASSIST BEING PROVIDED BY PHYSIOTHERAPIST TO PATIENT.

  Patient problems: Choking

  MAUDE report 14496902 ↗
• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE ISSUE WITH THE TRACHEOSTOMY WAS THAT IT WAS NOT FENESTRATED, SO WINDOWS WERE CREATED USING THE ATOS FENESTRATION PUNCH IN ONE OF THE INTERNAL CANNULAS AND THE EXTERNAL CANNULA. UNFORTUNATELY, THE INNER CANNULA WAS VERY SOFT AND WEAKENED DUE TO THE WINDOWS, MAKING IT IMPOSSIBLE TO INSERT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014077 ↗
• MalfunctionSep 22, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT PRESENTED FOR A TUBE CHANGE WITH A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT TTS, AS HE FELT LIKE HE WAS GOING TO VOMIT WHEN HE FILLS THE CUFF WITH AIR RARELY. IT WAS ALSO REPORTED THAT IT IS BELIEVED THAT THE ISSUE WAS BECAUSE THEY HAD BEEN TOO FORCEFUL WITH INSTILLING AIR/WATER. NO PATIENT INJURY WAS REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512243 ↗
• MalfunctionFeb 5, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE DEVICE WAS FOUND TO HAVE A FOREIGN SUBSTANCE ON THE TUBE. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11285321 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CUFF COMPONENT OF THE BIVONA TRACHEOSTOMY WAS FOUND TO BE LEAKING AFTER 72 HOURS OF USE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449253 ↗
• MalfunctionAug 25, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CUFF COMPONENT OF THE BIVONA TRACHEOSTOMY WAS FOUND TO BE LEAKING AFTER 72 HOURS OF USE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10447962 ↗
• InjuryMay 20, 2020Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT ONE DAY FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX BIVONA ADULT TTS TRACHEOSTOMY TUBE THE PATIENT BECAME SHORT OF BREATH AND THE VENTILATOR ALARMED. AN EMERGENT TUBE CHANGE OUT WAS PERFORMED SUCCESSFULLY. FOLLOWING REMOVAL OF THE TUBE, THE CUFF WAS FOUND TO BE LEAKING. NO FURTHER ADVERSE EVENTS WERE REPORTED.

  Patient problems: Respiratory Distress

  MAUDE report 10075919 ↗
• InjurySep 13, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE "HAD BEEN PIERCED" AFTER A FEW DAYS. THE PATIENT HAD DIFFICULTY BREATHING AT THE TIME OF THE EVENT. THE TRACHEOSTOMY TUBE WAS REPLACED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Dyspnea

  MAUDE report 6862275 ↗
• MalfunctionAug 11, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE WAS "PIERCED". THE PATIENT HAD RETURNED HOME FROM THE HOSPITAL WITH THE TRACHEOSTOMY TUBE. SEVEN DAYS LATER, THE CUFF WAS PIERCED. THE TRACHEOSTOMY TUBE WAS REPLACED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6788402 ↗
• MalfunctionAug 11, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE WAS "PIERCED". THE PATIENT HAD RETURNED HOME FROM THE HOSPITAL WITH THE TRACHEOSTOMY TUBE. SEVEN DAYS LATER, THE CUFF WAS PIERCED. THE TRACHEOSTOMY TUBE WAS REPLACED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6788391 ↗