Bivona 60PFS45Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15021312005875), received between Jul 23, 2021 and Dec 1, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (6 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, K944178); 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-2599-2024 · 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.

• MalfunctionDec 1, 2025Ventilation Problem in Device Environment; Ventilation Problem in Device Environment

  IT WAS STATED THAT THEY HAD A TRACHEOSTOMY THAT SPLIT ON THE ILET OF THE TRACHEOSTOMY FLANGE. THERE WAS PATIENT INVOLVEMENT. THE DETAILS OF THE PATIENT ARE: MALE AND THREE YEARS OLD AND WAS TREATED FOR UNDERLYING HEALTH CONDITION THAT REQUIRED THEM TO HAVE A TRACHEOSTOMY TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682346 ↗
• MalfunctionMay 27, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT CAME TO HER FATHER HOLDING HER TRACHEOSTOMY TUBE IN PLACE AS ONE OF THE EYE¿S THAT THE TAPES PASSED THROUGH AND SNAPPED WHICH SEEMED TO CAUSE THE TRACHEOSTOMY TUBE TO BE NO LONGER HELD IN PLACE. THE PARENTS HAD TO CARRY OUT AN EMERGENCY TUBE CHANGE.

  Patient problems: Hypoxia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089221 ↗
• InjuryMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT CAME TO HER FATHER HOLDING HER TRACHEOSTOMY TUBE IN PLACE AS ONE OF THE EYES THAT THE TAPES PASSE THROUGH HAD SNAPPED, WHICH MEANT THE TRACHEOSTOMY TUBE WAS NO LONGER HELD IN PLACE. THE PARENTS HAD TO CARRY OUT AN EMERGENCY TUBE CHANGE. THE EVENT OCCURRED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063115 ↗
• InjuryNov 11, 2024Break; Break

  IT WAS REPORTED THAT THE TRACHEOTOMY TUBE BROKE AND FELL OUT COMPLETELY WHILST THE PATIENT, A CHILD, WAS IN BED. THIS RESULTED IN AN EMERGENCY TRACHEOSTOMY TUBE INSERTION. THE FAMILY WAS ALERTED TO THE PATIENT MAKING GASPING NOISES AND DISCOVERED THAT PATIENT¿S TRACHEOSTOMY TUBE WAS COMPLETELY DISLODGED AND LAYING IN THE COT. THE FAMILY QUICKLY CARRIED OUT AN EMERGENCY TRACHEOSTOMY TUBE INSERTION. THE PATIENT RECOVERED WELL AND THIS ALL LASTED APPROXIMATELY JUST OVER ONE MINUTE. THE FAMILY DID NOT FEEL A MEDICAL REVIEW WAS REQUIRED. THE PATIENT HAD NO COLOR CHANGE AND NO CHANGE TO OXYGEN SATURATION OR HEART RATE NUMBERS. THE PATIENT'S FAMILY DISCOVERED THAT THE TRACHEOSTOMY TUBE HAD SNAPPED FULLY THROUGH WHERE THE NECK TAPE ATTACHED. THE TRACHEOSTOMY TUBE WAS ON THE 7TH WASH. FOLLOWING A DISCUSSION WITH THE PATIENT¿S RESPIRATORY TEAM, THE PATIENT IS NOW BEING CHANGED ONTO A DIFFERENT BRAND OF TRACHEOSTOMY TUBE. THE OPERATOR OF THE DEVICE WAS THE FAMILY OF THE PATIENT. THERE WAS NO HUMAN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652110 ↗
• MalfunctionNov 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FLANGE ON THE TUBE HAS SPLIT. 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 15826730 ↗
• MalfunctionSep 20, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A STRAIGHT FLANGE TRACHEOSTOMY TUBE INSTEAD OF A V SHAPED FLANGE TRACHEOSTOMY TUBE. FURTHER INFORMATION INDICATED THAT THE WRONG LABEL WAS ON THE PRODUCT RECEIVED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15456506 ↗
• MalfunctionSep 20, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE DEVICE IS MISLABELED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456480 ↗
• MalfunctionSep 20, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A HOSPITAL PRE-TEST, THE USER NOTICED THAT THE DEVICE WAS LABELED AS A V FLANGE TRACHEOSTOMY TUBE BUT THE PRODUCT WAS A STRAIGHT FLANGE TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456456 ↗
• MalfunctionSep 13, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT TWO TRACHS TUBES SHOULD HAVE A V-FLANGE BUT BOTH OF THEM WERE STRAIGHT. THEY ARE SEALED AND UNOPENED IN THE PACKAGING STILL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410204 ↗
• InjuryJul 7, 2022Fracture; Defective Component; Fracture; Defective Component

  IT WAS REPORTED THAT THE PATIENT WAS FIDGETING, PULLING THE TRACH TUBE AND DURING RE-INSERTION OF THE TRACH, IT WAS DISCOVERED THE TRACH WAS BROKEN WITH A SPLIT FLANGE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 10-JUN-2022: THE TRACHY CAME OUT AS IT WAS NOT SECURED DUE TO THE FLANGE BREAKING. THE PATIENT'S STOMA DID HAVE SOME IRRITATION AS A RESULT OF THIS INCIDENT IN ADDITION TO SOME INFECTION AS WE DID NOT HAVE ENOUGH TIME TO CHANGE DUE TO THE ISSUE NOT ALARMING IN GOOD TIME. WE HAD TO RE-INSERT, MANUALLY HOLD WHILST THE NEW ONE WAS PREPARED. HAS HAD TWO INFECTIONS SINCE THEN. MEDICAL INTERVENTION PROVIDED- WE HAD TO AMBU BAG THE PATIENT. WHAT IS THE OUTCOME OF THE PRODUCT FAULT: EMERGENCY TRACHEOSTOMY CHANGE AND UNNECESSARY DISTRESS TO THE CHILD. RESOLVED. THE TUBE WAS CHANGED AND THEN NOTICED THE SAME FAULT ON THAT ONE. THEY HAD BOTH ONLY BEEN USED ONCE. THE PATIENT HAD 3 TUBE CHANGES WITHIN HALF AN HOUR. ORIGINAL COMPLAINT WAS (B)(4).

  Patient problems: Decreased Respiratory Rate; Distress; Unspecified Infection

  MAUDE report 14944967 ↗
• MalfunctionJul 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS. MANUFACTURER MISLABELING OF TRACHS. OUTSIDE AND INNER BOX SAYS V FLANGE BUT THEY WERE STRAIGHT FLANGE. A STRAIGHT FLANGE WAS PLACED ON A PATIENT. FOUR MORE WERE FOUND WITH THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229876 ↗
• MalfunctionJul 23, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS. MANUFACTURER MISLABELING OF TRACHS. OUTSIDE AND INNER BOX SAYS V FLANGE BUT THEY WERE STRAIGHT FLANGE. A STRAIGHT FLANGE WAS PLACED ON A PATIENT. FOUR MORE WERE FOUND WITH THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221803 ↗
• MalfunctionJul 23, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS. MANUFACTURER MISLABELING OF TRACHS. OUTSIDE AND INNER BOX SAYS V FLANGE BUT THEY WERE STRAIGHT FLANGE. A STRAIGHT FLANGE WAS PLACED ON A PATIENT. FOUR MORE WERE FOUND WITH THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221782 ↗
• MalfunctionJul 23, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS. MANUFACTURER MISLABELING OF TRACHS. OUTSIDE AND INNER BOX SAYS V FLANGE BUT THEY WERE STRAIGHT FLANGE. A STRAIGHT FLANGE WAS PLACED ON A PATIENT. FOUR MORE WERE FOUND WITH THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221125 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K944178. 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-1145-2021 · Jan 18, 2021 · Terminated
  Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Us
• Z-0726-2021 · Dec 15, 2020 · Terminated
  PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
• 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.