Bivona 60PFS50Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15021312005882), received between Jul 10, 2017 and Dec 30, 2024 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Recalls naming this device

1. May 29, 2024Class IOpen, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE THE TRACHEOSTOMY TUBE WAS IN THE CHILD'S TRACHEA, A SPLIT WAS NOTICED WHERE THE FLEXTEND PART OF THE TUBE MET THE UNIVERSAL CONNECTOR. THIS RISKED THE TRACHEOTOMY TUBE BECOMING RIPPED FROM THE UNIVERSAL CONNECTOR. THE OPERATOR OF THE DEVICE WAS A HEALTHCARE PROFESSIONAL. THE DEFECT WAS NOTICED DURING A ROUTINE DAILY CHECK OF THE CHILD'S TUBE WHILE IT WAS IN USE. UNPLANNED NON-EMERGENCY TUBE CHANGE WAS UNDERTAKEN TO REPLACE AFFECTED TUBE, SO THE EVENT IS RESOLVED AS A NEW TUBE WAS INSERTED. THIS INCIDENT OCCURRED IN THE COMMUNITY IN THE PATIENT'S HOME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037119 ↗
• InjuryNov 30, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DAMAGE OCCURRED TO A BIVONA TUBE WHILE INSERTED IN A CHILD. THE FAMILY HAD STERILISED AND REUSED THE TUBE AS PER MANUFACTURER GUIDANCE. THIS DAMAGE OCCURRED ON ITS THIRD USE. NO PHYSICAL HARM WAS CAUSED TO THE CHILD HOWEVER HE HAD TO UNDERGO AN UNPLANNED TUBE CHANGE OUTSIDE OF HIS USUAL TWENTY-EIGHT (28) DAY CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240741 ↗
• MalfunctionApr 10, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE EYELETS AND THAT THE TWILL TAPES HAVE CUT THROUGH THE SILICONE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16710435 ↗
• MalfunctionDec 30, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE WIRE AND OR SPRING IS STICKING OUT ON THE END OF THE TRACHEOSTOMY. THE CUSTOMER DID NOT PLACE THE ITEM IN THEIR BODY BECAUSE THEY WERE CONCERNED ABOUT THE WIRE THAT WAS HANGING OUT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077735 ↗
• MalfunctionOct 18, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  CUSTOMER REPORTS TWO PRODUCTS LABELED WITH NONEXISTENT EXPIRATION DATES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626933 ↗
• InjuryMay 9, 2022Break; Break

  IT WAS REPORTED THAT WHILST IN USE IN A YOUNG PERSON, THE EYELET WAS DAMAGED, CLOSE TO FULLY SPLITTING WHILST ON THE TUBE'S 4TH USE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342975 ↗
• InjuryDec 17, 2020Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT THE BIVONA TUBE SPLIT. THE ISSUE WAS DISCOVERED AFTER TEN DAYS IN USE AND A TUBE CHANGE OUT PROCEDURE WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11030404 ↗
• MalfunctionOct 8, 2019Material Integrity Problem; Material Integrity Problem

  THE SURFACE ON A CANNULA OF A SMITHS MEDICAL TRACHEOSTOMY WAS REPORTED TO BE UNEVEN. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 9168554 ↗
• InjurySep 19, 2018Gel Leak; Material Integrity Problem; Material Split, Cut or Torn; Gel Leak; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CARETAKER, HEARD AN AUDIBLE LEAK, FOLLOWED BY AN ALARM FROM THE VENTILATOR. THE CARETAKER IMMEDIATELY REMOVED THE FAULTY TRACH TUBE AND INSERTED A NEW ONE, ON THE VENTILATOR DEPENDENT CHILD. IT WAS REVEALED THAT THE SILICONE ON THE FAULTY TUBE HAD A SPLIT AT THE TOP OF THE SHAFT, EXPOSING THE COILED WIRE. THE TRACH TUBE HAD ONLY BEEN USED TWICE AT THIS POINT. NO FURTHER COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891752 ↗
• InjurySep 19, 2018Gel Leak; Material Integrity Problem; Material Split, Cut or Torn; Gel Leak; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CARETAKER, HEARD AN AUDIBLE LEAK, FOLLOWED BY AN ALARM FROM THE VENTILATOR. THE CARETAKER IMMEDIATELY REMOVED THE FAULTY TRACH TUBE AND INSERTED A NEW ONE, ON THE VENTILATOR DEPENDENT CHILD. IT WAS REVEALED THAT THE SILICONE ON THE FAULTY TUBE HAD A SPLIT AT THE TOP OF THE SHAFT, EXPOSING THE COILED WIRE. THE TRACH TUBE HAD ONLY BEEN USED TWICE AT THIS POINT. NO FURTHER COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891751 ↗
• MalfunctionJul 10, 2017Leak/Splash; Split; Leak/Splash; Split

  IT WAS REPORTED THAT THE SILICONE ON A PORTEX BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS SILICONE TRACHEOSTOMY TUBE SPLIT AT THE TOP OF THE SHAFT, AND THE COIL WIRE WAS EXPOSED. THE TRACHEOSTOMY TUBE WAS IN USE WHEN A STAFF MEMBER HEARD AN AUDIBLE LEAK AND THE VENTILATOR ALARMED. THE TRACHEOSTOMY TUBE WAS REMOVED AND A NEW ONE WAS PLACED IMMEDIATELY. IT WAS AFTER REMOVAL THAT THE SPLIT IN THE SILICONE WAS OBSERVED. IT WAS NOTED THAT THE TRACHEOSTOMY TUBE HAD "ONLY BEEN USED TWICE". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6697687 ↗

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.