Bivona 67PFP60Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10351688518538), received between May 12, 2017 and Feb 11, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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-2611-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE ARE PROBLEMS WITH THE BALLOON: IT DOES NOT SWELL EVENLY, WHICH CREATES DIFFICULTIES IN VENTILATION. TROUBLESHOOTING WAS DONE BUT THE PROBLEM PERSISTS AND THE CANNULAS CANNOT BE USED. WHEN LOOKING AT THE CANNULA COMPARED TO OTHERS THERE IS A GAP BETWEEN THE STEM AND THE END OF THE BALLOON. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358102 ↗
• MalfunctionFeb 11, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE BALLOON WOULD NOT INFLATE EVENLY. THE USER PERFORMED THE CUFF MANIPULATIONS BUT THE PROBLEM PERSISTS. THE USER TRIED TO USE IT ON HIS SON TWICE BUT HE WAS "DESATURATING". THE CANNULA WAS COMPARED TO OTHERS, AND THERE APPEARED TO BE A GAP BETWEEN THE STEM AND THE END OF THE BALLOON. THE EVENT DATE IS UNKNOWN. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355139 ↗
• MalfunctionDec 27, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051805 ↗
• MalfunctionApr 29, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT TEN DAYS AFTER INSERTION, WHEN THE TUBE WAS REMOVED BY THE PATIENT'S FATHER FOR CLEANING, IT WAS OBSERVED THAT THE TUBE LENGTH APPEARED TO BE LONGER THAN USUAL. THE CUFF DID NOT LAY FLAT AGAINST SHAFT ONCE DEFLATED. NO CONSEQUENCE FOR PATIENT BUT FELT UNCOMFORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14249909 ↗
• MalfunctionMar 31, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT WHEN CHANGING THE TRACHEOSTOMY CANNULA AND INFLATING THE CUFF IT WAS IMPOSSIBLE TO HAVE A SEAL: LEAKAGE ON VENTILATION AND PAIN FOR THE PATIENT. WHEN REMOVING THE CANNULA, THEY NOTICED THAT THE CUFF REMAINED STUCK TO ONE WALL OF THE CANNULA. THE PATIENT WAS BADLY VENTILATED (FOR 20 MINUTES). THE CANNULA WAS CHANGED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Pain; Unspecified Respiratory Problem

  MAUDE report 13969107 ↗
• InjuryJan 17, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE WAS REPORTED TO BE EXPERIENCING SECRETIONS AND AIR COMING FROM THE STOMA WHEN THE CUFF IS NOT FULLY INFLATED. SUBSEQUENTLY, THE TRACH TUBE WAS REMOVED AND THE NURSE FILLED THE TRACH WITH WATER. A PINHOLE TEAR IN THE CUFF WAS OBSERVED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Code Available

  MAUDE report 8259005 ↗
• InjuryDec 28, 2018Separation Failure; Separation Failure

  INFORMATION WAS RECEIVED INDICATING THAT THE CONNECTOR CANNOT BE RELEASED FROM A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE. SUBSEQUENTLY, THE TUBE CHANGED OUT WITH NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202396 ↗
• MalfunctionMay 12, 2017Leak/Splash; Defective Component; Material Deformation; Leak/Splash; Defective Component; Material Deformation

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA FLEXTEND¿ TTS¿ PEDIATRIC TRACHEOSTOMY TUBE WAS ASYMMETRICAL, CAUSING A LEAK WHEN USED WITH A PATIENT'S VENTILATOR; MAKING IT DIFFICULT TO VENTILATE THE PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6563670 ↗

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.