Bivona 67SN035Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 15021312000252), received between Nov 19, 2018 and Nov 16, 2023 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (12 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-2615-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE TRACH TUBE OBTURATOR BROKE WHILE INSERTED IN TRACH TUBE PRIOR TO INSERTING TRACH TUBE IN PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155415 ↗
• MalfunctionFeb 8, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A PRE-TEST CUFF FAILURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330709 ↗
• MalfunctionJan 19, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED PER EMAIL: THE CUSTOMER HAD ISSUES WITH TWO NEONATAL BIVONA TTS CUFF TRACHS. THEY WERE UNABLE TO INFLATE THE CUFF ON BOTH TRACH'S PRIOR TO USING. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT HAPPENED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210536 ↗
• MalfunctionJan 19, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED PER EMAIL: THE CUSTOMER HAD ISSUES WITH TWO NEONATAL BIVONA TTS CUFF TRACHS. THEY WERE UNABLE TO INFLATE THE CUFF ON BOTH TRACH'S PRIOR TO USING. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT HAPPENED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210468 ↗
• MalfunctionDec 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO TRACHEOSTOMIES WILL NOT INFLATE DURING PRE-TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060791 ↗
• MalfunctionDec 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO TRACHEOSTOMIES WILL NOT INFLATE DURING PRE-TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060739 ↗
• MalfunctionJul 26, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THERE WAS A DEFECTIVE CUFF. ISSUE WAS DISCOVERED DURING THE CUFF PRE-CHECK PRIOR TO INSERTING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15106371 ↗
• MalfunctionApr 1, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD RECENTLY AN UNDETERMINED NUMBER OF TRACHS THAT THE CUFF IS NEARLY IMPOSSIBLE TO INFLATE DESPITE EXCESSIVE PRESSURE ? ALL OF THE WATER VOLUME REMAINS IN THE PILOT BALLOON. IT IS ONLY THROUGH ? PULLING" THE TTS CUFF OFF OF THE PILOT LINE THAT THEN WATER WILL PASS INTO THE CUFF. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978280 ↗
• InjuryApr 1, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A NEW TRACH WAS PREPARED FOR CHANGE (CLEAN AND AVAILABLE), BUT IT WAS NOTED THAT DESPITE GOOD INFLATION AND CUFF MASSAGE CUFF CONTINUOUSLY WOULD ASYMMETRICALLY INFLATE. THIS PROCESS WAS REPEATED MORE THAN 10 TIMES. ISSUE WAS RESOLVED BY USING A DIFFERENT TRACH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978057 ↗
• InjuryApr 1, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A VENTILATION LEAK NOTED IN PATIENT THAT COULD NOT RESOLVE DESPITE ADDITIONAL CUFF INFLATION. THE ISSUE WAS RESOLVED BY CHANGING OUT THE TRACH. THE VENTILATION WAS TEMPORARILY ADJUSTED TO COMPENSATE FOR THE LEAK THOUGH THE PATIENT WAS CLINICALLY STABLE THROUGHOUT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977917 ↗
• MalfunctionMar 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A BEDSIDE EXCHANGE BY THE ENT PROVIDER THE BALLOON WOULD NOT EXPAND FOR THE TRACH. THE REPORTED EVENT WAS RESOLVED BY REPLACING WITH A DIFFERENT TRACH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928090 ↗
• MalfunctionMar 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A BEDSIDE EXCHANGE BY THE ENT PROVIDER THE BALLOON WOULD NOT EXPAND FOR THE TRACH. THE REPORTED EVENT WAS RESOLVED BY PLACING A DIFFERENT TRACH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928045 ↗
• MalfunctionFeb 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF DOES NOT INFLATE WHEN CHECKED BEFORE CHANGING THE NEEDLE. THE DEVICE WAS RETURNED TO SMITHS MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508864 ↗
• MalfunctionDec 16, 2021Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL AND ATTACHED 10FEB202. NO PATIENT INVOLVEMENT. EVENT DETAILS UPDATED.

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

  MAUDE report 13022024 ↗
• InjuryJul 15, 2021Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH TUBE WAS TESTED PRIOR TO INSERTION AND IT SEEMED TO BE LOPSIDED AND NOT INFLATING PROPERLY. IT WAS INSERTED INTO THE PATIENT AND WAS NOT ABLE TO REMAIN INFLATED. INFLATION WAS ATTEMPTED TWO TIMES WHILE IN SITU WITHOUT RESOLUTION. THE CUFF WAS TAKEN OUT AND THEN FOUND TO NOT BE INFLATING AT ALL. A NEW TRACH WAS USED TO RESOLVE THE ISSUE. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174644 ↗
• MalfunctionNov 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DEVICE WAS PLACED IN USE WITH PATIENT BUT DID NOT FULLY INFLATE ON BOTH SIDES OF THE CUFF. THE DEVICE WAS REMOVED AND REPLACED TO CONTINUE VENTILATION. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10827274 ↗
• InjuryNov 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE WAS BEING PLACED IN USE WITH PATIENT. THE REPORTER STATED THE CUFF WOULD NOT INFLATE SYMMETRICALLY. THE REPORTER STATED THIS ISSUE CAUSED "DIFFICULTIES WITH VENTILATION" WITH PATIENT AND TRACHEOSTOMY TUBE HAD TO BE REMOVED AND REPLACED TO CONTINUE VENTILATION. NO FURTHER ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Hypoventilation

  MAUDE report 10805177 ↗
• InjuryNov 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION PROVIDED (B)(6): ADDED TO OPERATOR DETAILS TO SECTION D5 AND CONTACT DETAILS TO SECTIONS E2 AND E3.

  Patient problems: Hypoventilation

  MAUDE report 10805044 ↗
• MalfunctionSep 21, 2020Inflation Problem

  THE CUFF ON THE BIVONA TRACH WAS NOT INFLATING SYMMETRICALLY, CAUSING DIFFICULTIES WITH VENTILATION. THIS HAS HAPPENED TWICE WITH THIS SPECIFIC PATIENT. THE PATIENT HAD DIFFICULTIES VENTILATING, THE TRACH WAS CHANGED, AND IT WAS REALIZED THAT THE CUFF WAS NOT INFLATING SYMMETRICALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10559673 ↗
• MalfunctionNov 19, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING PLACEMENT OF A SMITHS MEDICAL PORTEX® BIVONA® TTS¿ TRACHEOSTOMY TUBE THE CUFF DID NOT INFLATE AS INTENDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8087463 ↗

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.