Bivona 67SP040Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 15021312000726), received between Jan 16, 2017 and Feb 3, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (13 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT THEY HAD TRACHEOSTOMY TUBE BREAK DURING A CHANGE WHEN THE ENTIRE RIGHT-SIDE FLANGE CRACKED OFF WHILE BEING REMOVED. THE DAMAGED TRACHEOSTOMY TUBE WAS DISCARDED BECAUSE IT COULD NO LONGER BE USED, AND IT HAD ONLY BEEN USED ONCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248241 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE FLANGE WAS COMING AWAY FROM THE HUB. THERE WAS NO PATIENT INJURY, AND THE TRACH WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297437 ↗
• MalfunctionJul 11, 2023Stretched; Stretched

  IT WAS REPORTED THAT PRIOR TO USE, THE CUFF WAS TESTED AND FOUND TO BE NOT SYMMETRICAL. CUSTOMER STATES THIS COULD CAUSE PRESSURE TO THE TRACHEA. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303246 ↗
• MalfunctionMar 28, 2023Material Discolored; Material Discolored

  E1 ADDITIONAL INFORMATION PROVIDED FOR REPORTING FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 16632175 ↗
• MalfunctionNov 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROVIDERS WERE HAVING DIFFICULTY WITH THE INITIAL INFLATION OF THE CUFFS. IT IS TAKING QUITE A BIT OF MANIPULATION FOR THE CUFF TO INFLATE AND LEAVES THEM UNEASY ABOUT USING THEM. THE PATIENT CURRENTLY HAS THE TRACH INSERTED AND THE DIFFICULTY INFLATING THE CUFF WAS DISCOVERED PRIOR TO PATIENT USE BUT THE TUBE WAS ULTIMATELY PLACED IN THE PATIENT. NO INJURY/INTERVENTION REPORTED AND WITH MUCH MANIPULATION THE CUFF WAS FINALLY ABLE TO BE INFLATED. EVENT IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798514 ↗
• MalfunctionNov 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROVIDERS WERE HAVING DIFFICULTY WITH THE INITIAL INFLATION OF THE CUFFS. IT IS TAKING QUITE A BIT OF MANIPULATION FOR THE CUFF TO INFLATE AND LEAVES THEM UNEASY ABOUT USING THEM. THE PATIENT CURRENTLY HAS THE TRACH INSERTED AND THE DIFFICULTY INFLATING THE CUFF WAS DISCOVERED PRIOR TO PATIENT USE BUT THE TUBE WAS ULTIMATELY PLACED IN THE PATIENT. NO INJURY/INTERVENTION REPORTED AND WITH MUCH MANIPULATION THE CUFF WAS FINALLY ABLE TO BE INFLATED. EVENT IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798429 ↗
• MalfunctionNov 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE ENT PROVIDERS HAVE REPORTED HAVING DIFFICULTY WITH INITIAL INFLATION OF MULTIPLE TRACH TUBE CUFFS. IT IS TAKING QUITE A BIT OF MANIPULATION OF THE CUFF TO GET IT TO INFLATE AND LEAVES THEM UNEASY ABOUT USING THEM. THE FOLLOWING IS INFORMATION FOR A TRACH THAT WAS PLACED YESTERDAY THAT WAS HARD TO INFLATE. THE PATIENT CURRENTLY HAS THE TRACH INSERTED. DIFFICULTY INFLATING THE CUFF WAS DISCOVERED PRIOR TO PATIENT USE BUT THE TUBE WAS ULTIMATELY PLACED IN THE PATIENT. NO INJURY/INTERVENTION, WITH MUCH MANIPULATION THE CUFF WAS FINALLY ABLE TO BE INFLATED. EVENT IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798356 ↗
• MalfunctionNov 1, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS OF THREE TRACHS WERE NOT INFLATING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708009 ↗
• MalfunctionSep 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF NOT EVENLY INFLATING. CUFF STICKING TO THE PLASTIC MOLDED CONTAINER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492217 ↗
• MalfunctionSep 26, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF NOT EVENLY INFLATING. CUFF STICKING TO THE PLASTIC MOLDED CONTAINER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487270 ↗
• MalfunctionSep 22, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT CUFF WOULD NOT INFLATE AND THE WATER WOULD NOT GO DOWN THE CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468979 ↗
• MalfunctionSep 22, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT CUFF WOULD NOT INFLATE AND THE WATER WOULD NOT GO DOWN THE CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468878 ↗
• MalfunctionSep 22, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF NOT EVENLY INFLATING. CUFF STICKING TO THE PLASTIC MOLDED CONTAINER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465782 ↗
• MalfunctionSep 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF INFLATING ASYMMETRICALLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461106 ↗
• MalfunctionSep 16, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT CUFF WOULD NOT INFLATE AND THE WATER WOULD NOT GO DOWN THE CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436876 ↗
• MalfunctionSep 14, 2022No Pressure; No Pressure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417196 ↗
• MalfunctionSep 13, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT CUFF WOULD NOT INFLATE AND THE WATER WOULD NOT GO DOWN THE CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414842 ↗
• MalfunctionSep 13, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT DURING A PRE-USE CHECK THE DEVICE CUFF DID NOT FULLY INFLATE DESPITE SIGNIFICANT AIR ADDED AND MANIPULATION TO IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410195 ↗
• MalfunctionSep 13, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT DURING A PRE-USE CHECK THE DEVICE CUFF DID NOT FULLY INFLATE DESPITE SIGNIFICANT AIR ADDED AND MANIPULATION TO IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410168 ↗
• MalfunctionApr 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14242663 ↗
• MalfunctionMar 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CUFF FAILED TO INFLATE. THE DEFECT WAS DISCOVERED PRIOR TO PLACING IN PATIENT. ANOTHER TRACH WAS BROUGHT TO THE ROOM, TESTED, AND USED ON PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710971 ↗
• MalfunctionMay 8, 2021Inflation Problem; Inflation Problem

  INVESTIGATION COMPLETED AND SUMMARY IN H 10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795369 ↗
• InjuryJun 9, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT DURING USE OF A SMITHS MEDICAL BIVONA TTS CUFFED PEDIATRIC WITH STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE THE PATIENT COULD NOT BREATHE AFTER CUFF INFLATION, TRIED TWICE. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8681471 ↗
• MalfunctionNov 20, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® BIVONA® TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS REPORTED TO BE NOT INFLATING. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8092593 ↗
• MalfunctionJan 16, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE INFLATION LINE BEGAN TO COME LOOSE FROM WHERE IT WAS ATTACHED ABOVE THE FLANGE AND THAT THE GLUE HAD LOOSENED. IT WAS NOTED THAT THE PATIENT WAS KNOWN TO PULL AT THE TUBING FOR INFLATION SOMETIMES. THE TRACHEOSTOMY TUBE WAS PROACTIVELY SWITCHED TO ANOTHER. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00188.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6254522 ↗

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.