Bivona 67PFSS30Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10351688518675), received between Nov 9, 2017 and Apr 20, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (11 reports).

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

1 other recall cover devices cleared under the same FDA submission (K923878); 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-2614-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Inflation Problem

  IT WAS STATED THAT WHEN THEY ATTEMPTED TO INSERT THE TRACH INTO THE PATIENT, THE CUFF WAS TESTED PRIOR TO INSERTION AND DID NOT INFLATE WITH WATER OR AIR. EVERYTHING INTRODUCED INTO THE CUFF, INCLUDING THE RETENTION BALLOON AT THE TOP, FLOWED BACK INTO THE SYRINGE. AS A RESULT, THE BACKUP TRACH WAS USED. WHEN THE BACKUP TRACH WAS INSERTED, THE PATIENT EXPERIENCED IMMEDIATE DISTRESS, SO IT WAS REMOVED. THE PATIENT¿S ORIGINAL TRACH WAS THEN REINSERTED. THEY WERE FORCED TO USE THE BACKUP TRACH BECAUSE THERE WAS NO ADDITIONAL TRACHEOSTOMY TUBE AVAILABLE IN THE HOME. THE PATIENT WAS A 10-MONTH-OLD TRACHEOSTOMY PATIENT ON A VENTILATOR, MAKING IT CRITICAL TO HAVE BACKUP TRACHEOSTOMY TUBE AVAILABLE IN THE HOME. THERE WAS REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925573 ↗
• MalfunctionMay 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO INFLATE. THE EVENT OCCURRED DURING UPON OPENING AT THE PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS THE PARENT. THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049623 ↗
• MalfunctionSep 25, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS CHECKED ACCORDING TO PROTOCOL BEFORE THE EXCHANGE, BUT IT DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305008 ↗
• MalfunctionJul 9, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WERE SOME TRACHS WITH FILAMENT GROWTHS IN THEM. THE EVENT OCCURRED AT THE HOSPITAL, THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704606 ↗
• MalfunctionJun 5, 2024Contamination; Contamination

  IT WAS REPORTED THAT MULTIPLE TRACHEOSTOMY TUBES ONCE PROCESSED BY CSR ARE BEING RETURNED TO UNIT WITH "FUZZY" SUBSTANCE ON OBTURATOR. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472883 ↗
• MalfunctionNov 14, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE PROPERLY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136158 ↗
• MalfunctionFeb 14, 2023Inflation Problem; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376569 ↗
• MalfunctionNov 2, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE UNIT INFLATED BUT CUFF DID NOT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15717844 ↗
• MalfunctionSep 23, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT MULTIPLE BIVONA TRACHS FAILED TO INFLATE DURING PRE-TEST. MULTIPLE LOTS AFFECTED WITH 11 TRACHS IN TOTAL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471059 ↗
• MalfunctionSep 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT MULTIPLE BIVONA TRACHS FAILED TO INFLATE DURING PRE-TEST. MULTIPLE LOTS AFFECTED WITH 11 TRACHS IN TOTAL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461863 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, TWO CUFFS WERE NOT INFLATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436662 ↗
• MalfunctionAug 2, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING PRE-USE CHECK OF A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE INFLATION OF THE PILOT BALLOON OCCURRED BUT THE CUFF DID NOT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7744962 ↗
• InjuryJun 13, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IMMEDIATELY ON USE OF THIS TRACHEOSTOMY TUBE, THE CUFF BEGAN LEAKING. A BACK UP DEVICE WAS USED TO REPLACE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598362 ↗
• InjuryNov 9, 2017Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ PEDIATRIC TRACHEOSTOMY TUBE WAS FOUND TO BE ASYMMETRICAL. THE PATIENT WAS NOTED TO BE UNRESPONSIVE, DUSKY IN APPEARANCE WITH AN OXYGEN SATURATION IN THE 40'S. THE PATIENT WAS REQUIRED TO BE MANUALLY BAGGED BY THE NURSE AND AN EMERGENT TRACHEOSTOMY (TRACH) CHANGE OUT WAS REQUIRED. UPON INSPECTION OF THE REMOVED TRACH, THE CUFF WAS NOT SYMMETRICAL WITH IT BEING INFLATED MORE ON ONE SIDE. THE PATIENT RECOVERED WITH NO FURTHER ADVERSE EFFECTS.

  Patient problems: Hypoxia; Loss of consciousness; Low Oxygen Saturation

  MAUDE report 7015351 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.