Bivona 750170Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 15021312006414), received between Aug 22, 2018 and Apr 4, 2025 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K083641, K914088); they may or may not involve this specific model.

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-2589-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF HAD AIR LEAKING ISSUES, AND MORE AIR WAS SUPPLIED. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774602 ↗
• MalfunctionSep 3, 2024Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD A CUFF LEAK AFTER FOUR DAYS OF USE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127789 ↗
• MalfunctionMay 11, 2023Defective Device; Defective Device

  IT WAS REPORTED, THAT THERE WAS A RESPIRATORY ISSUE. TUBE INSERTED ON (B)(6) 2022 AND REMOVED ON (B)(6) 2022. SAME PATIENT AS COMPLAINT FILES (B)(6). NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915817 ↗
• InjuryApr 19, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT COULD NOT PROPERLY BREATH WITH THE DEVICE. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Airway Obstruction

  MAUDE report 16766517 ↗
• MalfunctionApr 17, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752326 ↗
• MalfunctionApr 14, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS A RESPIRATORY ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742421 ↗
• MalfunctionOct 17, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE CUFF IS FAULTY IN THE SET. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620459 ↗
• MalfunctionSep 26, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THERE WAS NO DEFECTION THAT WAS DETECTED DURING PRE-TEST, HOWEVER, CUFF CONSTANTLY REQUIRED PUMPING WHEN PLACED INSIDE PATIENT. PATIENT REQUIRES VENTILATOR. DEFECTIVE PRODUCT WAS REPLACED.

  Patient problems: Ventilator Dependent

  MAUDE report 15487957 ↗
• MalfunctionSep 13, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT DEVICE'S BALLOON WAS INFLATING ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415070 ↗
• InjuryMar 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHILE THE PATIENT'S SPOUSE WAS ATTEMPTING TO CHANGE A CANNULA BUT, THE SPOUSE NOTED THE REPLACEMENT CANNULA HAD A DYSFUNCTIONAL CUFF (ASYMMETRIC CUFF AND NOT ALLOWING ADEQUATE VENTILATION).THEY THEREFORE TOOK THE LAST CANNULA (WITH NO ANOMALY) AND WAS ABLE TO MAKE A CHANGE OF CANNULA, RESOLVING THE REPORTED EVENT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13710677 ↗
• InjuryMar 9, 2022Break; Break

  IT WAS REPORTED THAT DURING THE NIGHT, THE TRACHEAL CANNULA CUFF SUDDENLY RUPTURED ALONG ITS ENTIRE LENGTH (THIS PATIENT HAVING NO POSSIBLE MOBILITY AND NO RESPIRATORY CAPACITY TO ACHIEVE HYPERPRESSURE). THE PATIENT'S SPOUSE WAS ABLE TO EVENTUALLY REPLACE THE CANNULA.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13710649 ↗
• InjuryFeb 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AN ASYMMETRIC CUFF WAS OBSERVED WITH THE TRACHEOSTOMY TUBE ALONG WITH WATER BEING PRESENT. ISSUE OCCURRED WHILE IN USE WITH PATIENT. PATIENT HAD RESPIRATORY DIFFICULTIES. AIRWAY WAS MAINTAINED BY CHANGING THE TRACHEOSTOMY WHICH RESOLVED THE ISSUE.

  Patient problems: Respiratory Insufficiency

  MAUDE report 13501530 ↗
• InjuryFeb 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AN ASYMMETRIC CUFF WAS OBSERVED WITH THE TRACHEOSTOMY TUBE ALONG WITH WATER BEING PRESENT. ISSUE OCCURRED WHILE IN USE WITH PATIENT. PATIENT HAD RESPIRATORY DIFFICULTIES. AIRWAY WAS MAINTAINED BY CHANGING THE TRACHEOSTOMY WHICH RESOLVED THE ISSUE.

  Patient problems: Respiratory Insufficiency

  MAUDE report 13501276 ↗
• InjuryFeb 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AN ASYMMETRIC CUFF WAS OBSERVED WITH THE TRACHEOSTOMY TUBE ALONG WITH WATER BEING PRESENT. ISSUE OCCURRED WHILE IN USE WITH PATIENT. PATIENT HAD RESPIRATORY DIFFICULTIES. AIRWAY WAS MAINTAINED BY CHANGING THE TRACHEOSTOMY WHICH RESOLVED THE ISSUE.

  Patient problems: Respiratory Insufficiency

  MAUDE report 13500854 ↗
• InjuryFeb 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AN ASYMMETRIC CUFF WAS OBSERVED WITH THE TRACHEOSTOMY TUBE ALONG WITH WATER BEING PRESENT. ISSUE OCCURRED WHILE IN USE WITH PATIENT. PATIENT HAD RESPIRATORY DIFFICULTIES. AIRWAY WAS MAINTAINED BY CHANGING THE TRACHEOSTOMY WHICH RESOLVED THE ISSUE.

  Patient problems: Respiratory Insufficiency

  MAUDE report 13500579 ↗
• InjuryAug 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT AIRE-CUFF MALFUNCTIONED WHEN PLACED IN THE PATIENT, TWO TRACH CUFFS WOULD NOT INFLATE. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442967 ↗
• InjuryAug 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT AIRE-CUFF MALFUNCTIONED WHEN PLACED IN THE PATIENT, TWO TRACH CUFFS WOULD NOT INFLATE. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442941 ↗
• MalfunctionAug 23, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE BALLOON TO A SMITHS MEDICAL PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBE WOULD DEFLATE. THE BALLOON WAS REQUIRED TO BE INFLATED EVERY TWO HOURS WITH 1-2MLS OF AIR. IT WAS REPORTED THAT THE PATIENT WAS UNDER VENTILATED FOR 22 HOURS. THE CANNULA WAS REPORTED TO BE CHANGED EVERY 15 DAYS. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7808917 ↗
• MalfunctionAug 22, 2018Fitting Problem; Defective Component; Material Deformation; Fitting Problem; Defective Component; Material Deformation

  INFORMATION WAS RECEIVED INDICATING THAT THE SPEAKING VALVE WAS UNABLE TO CONNECT TO A SMITHS MEDICAL PORTEX® BIVONA® AIRE-CUF® TRACHEOSTOMY TUBE. IT WAS NOTED THAT THE 15MM CONNECTOR IS OUT OF SPECIFICATION. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7805216 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K914088. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0930-05 · Apr 26, 2005 · Terminated
  Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Z-0302-06 · Feb 17, 2005 · Terminated
  Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.