Bivona 670180Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 15021312006070), received between Feb 10, 2017 and Sep 18, 2026 — classified as 50 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (32 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 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823433 ↗
• MalfunctionAug 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175969 ↗
• MalfunctionJul 27, 2026Deflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50018198 ↗
• MalfunctionJun 9, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A TRACHEOSTOMY TUBE WAS IDENTIFIED TO HAVE CONCEALED DAMAGE AND HOLES WERE FOUND. THE EVENT OCCURRED DURING ATTEMPTED FIRST USE AND WAS IDENTIFIED BY THE PATIENT WITH DIABETES (PWD). THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445411 ↗
• MalfunctionJun 9, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A TRACHEOSTOMY TUBE WAS IDENTIFIED TO HAVE CONCEALED DAMAGE AND HOLES WERE FOUND. THE EVENT OCCURRED DURING ATTEMPTED FIRST USE AND WAS IDENTIFIED BY THE PATIENT WITH DIABETES (PWD). THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444810 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A LEAKAGE DURING THE FIRST DAY OF USE. ANOTHER TRACH TUBE WAS USED AND THE ISSUE RESOLVED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558664 ↗
• MalfunctionFeb 19, 2026Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A LEAKAGE. UPON REMOVAL, THE LEAKAGE WAS FOUND AT THE INFLATION LINE. ANOTHER TRACH TUBE WAS USED AND THE ISSUE RESOLVED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389727 ↗
• MalfunctionJan 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT ON THE 11TH DAY OF USE, IT WAS NOTED THAT THE PATIENT¿S EXHALED VOLUME APPEARED LOWER THAN WHAT THE VENTILATOR DELIVERED, INDICATING A POSSIBLE LEAK. AFTER REMOVAL, A LEAK WAS FOUND AT THE INFLATION LINE. THE ISSUE WAS FIXED BY REPLACING THE TUBE, AND THE VENTILATOR READINGS RETURNED TO NORMAL. THE EVENT HAPPENED WHILE THE PATIENT WAS USING THE DEVICE IN A HOSPITAL UNDER THE CARE OF A HEALTH PROFESSIONAL. THE OUTCOME WAS RESOLVED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058048 ↗
• MalfunctionJan 8, 2026Contamination

  IT WAS REPORTED THAT MOLD WAS FOUND IN THE TRACHEAL CANNULA WHILE IT WAS BEING REMOVED. THE CANNULA WAS REUSABLE AND WAS REPROCESSED UP TO 10 TIMES. PRIOR TO INSERTION, THE TRACHEAL CANNULA HAD BEEN CLEANED AND STORED AS INSTRUCTED BY THE PROVIDER AND IN ACCORDANCE WITH THE USER INSTRUCTIONS. THERE WERE NO HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002907 ↗
• MalfunctionDec 22, 2025Tear, Rip or Hole in Device Packaging; Gas/Air Leak; Tear, Rip or Hole in Device Packaging; Gas/Air Leak

  IT WAS REPORTED THAT ON THE 7TH DAY OF USE, IT WAS OBSERVED THAT THE EXHALED VOLUME FROM THE PATIENT WAS LOWER THAN DELIVERED BY THE VENTILATOR, SUGGESTING A POSSIBLE LEAK. PER REPORTER, UPON REMOVAL, LEAKAGE WAS FOUND AT THE INFLATION LINE. THE TUBE WAS REPLACED AND THE ISSUE WAS RESOLVED. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864099 ↗
• MalfunctionDec 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A LEAKAGE. UPON REMOVAL, THE LEAKAGE WAS FOUND AT THE INFLATION LINE. ANOTHER TRACH TUBE WAS USED AND THE ISSUE RESOLVED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693525 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A LEAKAGE DURING THE FIRST DAY OF USE. ANOTHER TRACH TUBE WAS USED AND THE ISSUE RESOLVED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692865 ↗
• MalfunctionNov 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED LEAKAGE DURING PRETEST. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594704 ↗
• MalfunctionSep 9, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT, WHEN ATTEMPTING TO REMOVE THE TRACHEOSTOMY TUBE AFTER A MONTH OF USE, CUFF DEFLATION WAS FOUND TO BE DIFFICULT, WITH ONLY 1 CC OF WATER WITHDRAWN. PER REPORTER, THE TUBE WAS THEN SLOWLY REMOVED USING A STYLET WHILE THE CUFF REMAINED INFLATED. SUBSEQUENT TESTING CONFIRMED THAT THE CUFF COULD NOT BE DEFLATED OR INFLATED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE PATIENT¿S HOME. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011409 ↗
• MalfunctionJun 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON THE FIRST TRACHEOSTOMY TUBE SET, LEAKAGE WAS DISCOVERED AFTER TWO DAYS OF USAGE. THE REPORTER NOTED THAT ON THE SECOND ONE, LEAKAGE WAS DISCOVERED AFTER FOUR DAYS OF USAGE. THE OLD TRACHEOSTOMY TUBE WAS REPLACED WITH A NEW ONE. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285726 ↗
• MalfunctionJun 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON THE FIRST TRACHEOSTOMY TUBE SET, LEAKAGE WAS DISCOVERED AFTER TWO DAYS OF USAGE. THE REPORTER NOTED THAT ON THE SECOND ONE, LEAKAGE WAS DISCOVERED AFTER FOUR DAYS OF USAGE. THE OLD TRACHEOSTOMY TUBE WAS REPLACED WITH A NEW ONE. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285720 ↗
• InjuryJun 12, 2025Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT CUFF LEAKAGE WAS FOUND WITH THE FIRST TRACHEOSTOMY TUBE RIGHT AFTER IT WAS PLACED ON THE PATIENT. SECOND TUBE WAS PLACED AND FOUND CUFF LEAKAGE AGAIN RIGHT AFTER IT WAS PLACED IN THE PATIENT. BOTH TUBES WERE PRE-TESTED BEFORE PLACEMENT. PRODUCT WAS OPERATED BY A HEALTH PROFESSIONAL INSIDE A HOSPITAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196356 ↗
• InjuryMay 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE LEAKAGE WAS FOUND AFTER 9 DAYS OF USE. THIS PROBLEM WAS RESOLVED BY REPLACING A NEW AIR-CUFF. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048301 ↗
• MalfunctionMay 14, 2025Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT CUFF LEAKAGE WAS FOUND AFTER 10 DAYS OF USE. THE PROBLEM WAS RESOLVED BY REPLACING THE TRACH TUBE WITH A NEW ONE. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT AT THE HOSPITAL. THE DEVICE WAS OPERATED BY THE USER/PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018882 ↗
• MalfunctionMay 12, 2025Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON SEEMED TO BECOME POROUS QUITE QUICKLY, AS IT ALREADY DEFLATES ON THE FIRST DAY OF INSERTION FOLLOWING STERILIZATION. DURING THE STERILIZATION, RESIDUAL WATER AND A SUSPICIOUS APPEARANCE OF THE BALLOON WERE OBSERVED. THERE WERE NO PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005859 ↗
• MalfunctionMar 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKAGE WAS FOUND AFTER USING ON THE PATIENT IN 7 DAYS. THE PROBLEM WAS RESOLVED WHEN A NEW TRACHEOSTOMY TUBE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618962 ↗
• MalfunctionFeb 25, 2025Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON SEEMED TO BECOME POROUS QUITE QUICKLY, AS IT ALREADY DEFLATES ON THE FIRST DAY OF INSERTION FOLLOWING STERILIZATION. DURING THE STERILIZATION, RESIDUAL WATER AND A SUSPICIOUS APPEARANCE OF THE BALLOON WERE OBSERVED. THERE WERE NO PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463353 ↗
• MalfunctionFeb 12, 2025Contamination; Contamination

  IT WAS REPORTED THAT MOLD WAS FOUND IN THE TRACHEAL CANNULA WHILE IT WAS BEING REMOVED. THE CANNULA WAS REUSABLE AND WAS REPROCESSED UP TO 10 TIMES. PRIOR TO INSERTION, THE TRACHEAL CANNULA HAD BEEN CLEANED AND STORED AS INSTRUCTED BY THE PROVIDER AND IN ACCORDANCE WITH THE USER INSTRUCTIONS. THERE WERE NO HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368315 ↗
• MalfunctionJan 27, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF LEAKAGE WAS DETECTED WHEN THE DEVICE WAS FIRST USED ON PATIENTS. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242159 ↗
• MalfunctionJan 27, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKAGE WAS DETECTED WHEN THE DEVICE WAS FIRST USED ON PATIENTS. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. MPEPITO (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242054 ↗