Bivona 750180Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 15021312006421), received between Mar 7, 2017 and Jul 27, 2026 — classified as 2 deaths, 9 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035244 ↗
• MalfunctionJul 27, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024964 ↗
• MalfunctionAug 27, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOTOMY BALLOON DID NOT REMAIN INFLATED AND HAD SIGNIFICANT LEAKS. THERE WAS A PATIENT INVOLVEMENT. PATIENT IMPACT: VENTILATORY DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903351 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CANNULA WAS INSTALLED ON 28-JUL WITHOUT PROBLEM. ON 01-AUG-2025: OBSERVATION OF BLOATING LEAK, BALLOON FRAGILITY AT THE INTRODUCTION OF THE CANNULA IN A PERCUTANEOUS TRACHEOTOMY. PATIENT IMPACT: DESATURATION. THERE WAS 1 PATIENT INVOLVEMENT. NO CONSEQUENCES FOR THE CURRENT CONDITION OF THE PATIENT. ACTIONS TAKEN FOR THE PATIENT: CHANGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893384 ↗
• MalfunctionAug 1, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE CUFF LOSES AIR. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686616 ↗
• MalfunctionAug 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CUFF WAS ADHERED AND COULDN¿T BE FULLY INFLATED DURING PRE-TEST. THE USER FOLLOWED THE IFU (INSTRUCTIONS FOR USE) AND TRIED TO REMOVE THE ADHESION BY MASSAGING THE CUFF BUT WAS IN VAIN. THEY THEN OPENED A NEW ONE BUT WAS ALSO HAVING THE SAME PROBLEM. REPLACED WITH THIRD DEVICE. THE EVENT OCCURRED DURING PRE-TEST; NO PATIENT WAS INVOLVED OR HARMED. ONE PATIENT, TWO PRODUCT MALFUNCTIONS. EMDR-30804 AND EMDR-32419 BOTH REPRESENT THE SAME PATIENT. THIS IS THE SECOND MALFUNCTION REPORT FOR THE RELATED COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911994 ↗
• MalfunctionAug 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CUFF WAS ADHERED AND COULDN'T BE FULLY INFLATED DURING PRE-TEST. THE USER FOLLOWED THE IFU (INSTRUCTIONS FOR USE) AND TRIED TO REMOVE THE ADHESION BY MASSAGING THE CUFF BUT WAS IN VAIN. THEY THEN OPENED A NEW ONE BUT WAS ALSO HAVING THE SAME PROBLEM. REPLACED WITH THIRD DEVICE. THE EVENT OCCURRED DURING PRE-TEST; NO PATIENT WAS INVOLVED OR HARMED. ONE PATIENT, TWO PRODUCT MALFUNCTIONS. EMDR (B)(4) AND EMDR (B)(4) BOTH REPRESENT THE SAME PATIENT. THIS IS THE FIRST MALFUNCTION REPORT FOR THE RELATED COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911934 ↗
• InjuryApr 25, 2024Inflation Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Unintended Deflation; Inflation Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT FELT UNCOMFORTABLE AFTER THE TRACHEOSTOMY TUBE HAD BEEN PLACED FOR 3 DAYS. UNUSUAL GRADUAL CUFF DEFLATION WAS FOUND UPON REMOVAL OF THE TUBE. AN ASYMMETRIC CUFF WAS ALSO OBSERVED WHEN INFLATED. THIS PROBLEM WAS SOLVED BY REPLACING WITH A NEW ONE. THIS EVENT OCCURRED IN THE PATIENT HOME AND WHILE IN USE OF PATIENT. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183375 ↗
• MalfunctionNov 8, 2023Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: NO MEDICAL INTERVENTION REQUIRED. DATE OF THE EVENT WAS UPDATED FROM UNKNOWN TO 5-OCT-2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095363 ↗
• MalfunctionNov 8, 2023Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL. NO MEDICAL INTERVENTION REQUIRED. DATE OF THE EVENT WAS UPDATED FROM UNKNOWN TO (B)(6) 2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095219 ↗
• MalfunctionMay 9, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUFF WAS STUCK IN THE BODY OF THE TUBE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897254 ↗
• MalfunctionApr 12, 2023Loss of or Failure to Bond; Deflation Problem; Material Too Soft/Flexible; Loss of or Failure to Bond; Deflation Problem; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE CANNULA COULD NOT BE BLOCKED. IT WAS BLOCKED WITH 12 MILLILITERS (ML) OF AIR TO BEGIN WITH. THERE WAS A KINK/ADHESION ON THE SIDE OF THE CUFF BALLOON AND THE CUFF COULD NOT BE COMPLETELY BLOCKED PROPERLY. AFTER REPEATED UNBLOCKING AND BLOCKING, THE ADHESION CAME OFF. HOWEVER, AT 28-30 BAR, THE CUFF AND TEST BALLOON WERE VERY SOFT AND MISSHAPEN. IN THE END, UNBLOCKING COULD NOT BE DONE COMPLETELY WITH A CUFF MANAGER. RESIDUAL AIR IN THE CUFF HAD TO BE UNBLOCKED WITH A SYRINGE. WITH THE CANNULA IN PLACE, THIS COULD HAVE LED TO SEVERE IRRITATION OR EVEN DAMAGE TO THE PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728337 ↗
• InjuryMar 24, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS DEFECTIVE, THE CUFF INFLATED ON THE ONLY SIDE. LOT NUMBER INVOLVED CONFIRMED BY PICTURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023. THERE WAS POOR VENTILATION FOLLOWED BY A PROBLEM WITH THE TUBE, LEAKAGE. THE TUBE WAS CHANGED ON (B)(6) 2023. NO REPORT OF PATIENT INVOLVEMENT OR INJURY.

  Patient problems: Respiratory Insufficiency

  MAUDE report 16611015 ↗
• MalfunctionJan 18, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE CUFF LEAKAGE TEST, THE CUFF DID NOT FULLY INFLATE. NO CLINICAL CONSEQUENCES, NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195720 ↗
• MalfunctionNov 18, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COULD NOT BE FULLY EXPANDED, PROBLEM DISCOVERED DURING TESTING UPON OPENING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829424 ↗
• InjurySep 21, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOT TOLERATING THE SPEAKING VALVE FOLLOWING PLACEMENT OF THE TRACH TUBE AND EVEN DECREASED ORAL INTAKE RESULTED IN MORE PAIN. THIS EVENT REQUIRED MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 15461530 ↗
• MalfunctionSep 16, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CUFF WOULD INFLATE ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436936 ↗
• MalfunctionSep 13, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PRE-TEST, PART OF THE CUFF WAS STICKING TO THE CANNULA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410612 ↗
• MalfunctionAug 31, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT'S CUFF ON THE TRACHEOSTOMY TUBE WOULD NOT REMAIN DEFLATED TO ALLOW PATIENT VOCALIZATION. STAFF WERE REQUIRED TO DEFLATE CUFF HOURLY FOR PATIENT TO VOICE. THE CUFF PRESSURE WAS MEASURED WITH A CUFF MANOMETER AND THE CUFF WOULD RE-INFLATE TO ~10MMHG. TUBE REMAINED INSITU UNTIL (B)(6) 2022, WHEN PLANNED TRACHEOSTOMY TUBE CHANGE OCCURRED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331803 ↗
• InjuryAug 2, 2021Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY SILICONE - BIVONA TUBES ADULT AIRE-CUFF REQUIRED INTERVENTION TO PRECLUDE SERIOUS IMPAIRMENT. REPORTED WHILE IN USE WITH THE PATIENT, THE CUFF KEPT DEFLATING WHICH CAUSED BREATHING ISSUES FOR THE PATIENT. IT WAS REPORTED CUFF WAS ORIGINALLY INFLATED WITH 30ML OF AIR. THE PATIENT WAS BEING OBSERVED AT HOME AND THEN NEEDED TO BE HOSPITALIZED. THE PATIENT WAS EXAMINED AND NO SIGNS OF TRACHEOMALACIA WAS IDENTIFIED. THE TUBE WAS REPLACED AND REPORTED PATIENT STATUS REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12259365 ↗
• InjuryJan 20, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL BIVONA SILICONE TRACHEOSTOMY SILICONE TUBE'S CUFF WAS NOT INFLATING PROPERLY AND WAS RUPTURING ON ONE SIDE. THE PATIENT'S SATURATION WAS GOING DOWN DURING USE. A TRACH CHANGE OUT WAS DONE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11202450 ↗
• MalfunctionOct 17, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT AFTER 24 HOURS IN USE, THE CUFF OF A SMITHS MEDICAL TRACHEOSTOMY DEFLATED. NO PATIENT INJURY OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204671 ↗
• InjuryOct 1, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBE DEFLATED 4-6 TIMES WHILE IN USE. STEADY CUFF PRESSURE WAS NOT ABLE TO BE MAINTAINED WHICH IS BELIEVED TO HAVE LED TO PATIENT ASPIRATING SECRETIONS. SUBSEQUENTLY, IT WAS REQUIRED TO PERFORM TRACH TUBE CHANGE OUT AS THE PATIENT WAS DIAGNOSED WITH ASPIRATION PNEUMONIA. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Aspiration/Inhalation; Pneumonia

  MAUDE report 9141825 ↗
• InjuryMar 5, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE WHITE VALVE FROM THE PILOT BALLOON OF A SMITHS MEDICAL BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOSTOMY TUBE "WENT IN AND NEVER CAME BACK OUT. THEREFORE THE PATIENT LEAKED". SUBSEQUENTLY, AN EMERGENT TRACHEOSTOMY TUBE CHANGE OUT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391664 ↗
• InjuryMar 5, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE WHITE VALVE FROM THE PILOT BALLOON OF A SMITHS MEDICAL BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOSTOMY TUBE "WENT IN AND NEVER CAME BACK OUT. THEREFORE THE PATIENT LEAKED". SUBSEQUENTLY, AN EMERGENT TRACHEOSTOMY TUBE CHANGE OUT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391663 ↗

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.