Bivona 67SP050Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 15021312000740), received between Mar 1, 2019 and Jul 6, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Contamination” (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-2615-2024 · 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.

• MalfunctionJul 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBE CUFF WAS LEAKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716664 ↗
• MalfunctionMay 10, 2023Contamination; Contamination

  IT WAS REPORTED THAT A PATIENT REPORTED A BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901432 ↗
• MalfunctionMar 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE PATIENT REPORTED BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631630 ↗
• MalfunctionMar 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE PATIENT REPORTED BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630188 ↗
• MalfunctionMar 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE PATIENT REPORTED BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630137 ↗
• MalfunctionMar 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE PATIENT REPORTED BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630123 ↗
• MalfunctionMar 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE PATIENT REPORTED BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630006 ↗
• MalfunctionMar 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE. PATIENT REPORTED BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629955 ↗
• MalfunctionMar 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE PATIENT REPORTED BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629918 ↗
• MalfunctionMar 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE.PATIENT REPORTED BLACK RESIDUE ON THE SEAM AT THE END OF THE CUFF FOR 8 CUFFS. THIS WAS FOUND WHEN THE TRACH WAS REMOVED FROM THE AIRWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629866 ↗
• MalfunctionMar 14, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE TUBE DID NOT EXPAND PROPERLY DESPITE 10-15 ATTEMPTS WITH STERILE H20. ISSUE WAS DISCOVERED DURING PRE-TEST AND NOT USED ON PATIENT. ANOTHER TRACH SAME SIZE AND MAKE WAS USED AND TESTED OUT NORMALLY PRIOR TO USE.

  Patient problems: Insufficient Information

  MAUDE report 16539933 ↗
• InjuryFeb 2, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE TRACH TUBE WAS DEFECTIVE. THIS WAS FOUND AFTER A DAY OF USE. NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16286045 ↗
• MalfunctionSep 13, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT DURING THE PRE-TEST OF THE DEVICE, THE CUFF WOULD NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410021 ↗
• MalfunctionMar 4, 2022Crack; Crack

  IT WAS REPORTED THAT THE FLANGE INSPECTED ON SECOND TRACH AND A CRACK WAS NOTED ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667093 ↗
• MalfunctionMar 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT WAS FOUND WITH TRACH IN HAND, CUFF SIDE FLANGE ATTACHED TO TRACH, TIES SEPARATED FROM STEM/BASE OF TRACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667035 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED THAT ONE OF THE PATIENTS TRACH TUBES BROKE AT THE SHAFT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480714 ↗
• MalfunctionFeb 8, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY DEVICE ONLY INFLATES ON ONE SIDE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480547 ↗
• MalfunctionMay 24, 2021Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS NOT INFLATING UPON OPENING THE PACKAGE. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873720 ↗
• MalfunctionMar 1, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY TUBE CUFF WOULD NOT INFLATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384138 ↗

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.