Bivona 60NFP40Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 15021312014747), received between Apr 30, 2018 and Jul 10, 2025 — classified as 15 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Disconnect” (16 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. How this data works · Data updated Oct 13, 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-2592-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PARENT WAS PLANNING A TUBE CHANGE WHEN A SMALL DEFECT WAS NOTICED ON THE TUBE, AT THE END OF THE SHAFT. THE DEFECT WAS DESCRIBED AS ¿A SMALL CIRCULAR SHAPE, A HOLE, A BUBBLE¿ WITHIN THE SHAFT TUBING. THE REMAINING TUBES WERE NOT USED AS ALTERNATIVES. THE FAULT WAS NOTICED BY THE PARENTS BEFORE USE, WHEN BOX WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473361 ↗
• MalfunctionMar 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A SPLIT IN THE FLANGE OF THE TRACHEOSTOMY IN USE. THE EVENT DID OCCUR IN THE PATIENT'S HOME. THE PARENT NOTICED THE TEAR IN THE FLANGE. THERE WAS NO PATIENT HARM BECAUSE THE PARENT CHANGED THE TRACHEOSTOMY TUBE ONCE THE TEAR WAS NOTICED AND INFORMED THE CHILD'S NURSE. OTHER RELEVANT HISTORY, INCLUDING PRE-EXISTING CONDITIONS: THE PATIENT USES VENTILATION DUE TO CONGENITAL CENTRAL HYPOVENTILATION SYNDROME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596138 ↗
• MalfunctionFeb 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RESISTANCE ON SUCTIONING WHILE THE TRACHEOSTOMY TUBE ON WAS PUT ON. THE SIMILAR SITUATION HAPPENED WHEN THEY SWITCHED TO A NEW DEVICE. PATIENT REPORTED TO HAVE THICK SECRETIONS. PARENTS REPORTED THAT THE SUCTION CATHETER INSERTED WITH EASE BUT AND THEY HAD TO FORCE THE CATHETER TO OVERCOME THE RESISTANCE. CORRECT SUCTION CATHETER SIZE WAS USED. THERE WERE NO HARMS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Respiratory Insufficiency

  MAUDE report 21415578 ↗
• MalfunctionJan 5, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS BROKEN. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18457630 ↗
• MalfunctionJul 19, 2023Material Discolored; Material Split, Cut or Torn; Material Discolored; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PARENT CONTACTED CONCERNED THAT THEY HAD DISCOVERED A SPLIT IN THE TUBING OF A TRACHEOSTOMY TUBE ON REMOVAL FROM THE CHILD. THE BACK UP TRACHEOSTOMY TUBE THEY WERE ABOUT TO INSERT WAS ALSO FOUND TO HAVE AN AREA THAT APPEARED SIMILARLY DISCOLORED. THE PLASTIC WAS DISCOLORED AND MAY ALSO HAVE A MICRO SPLIT THAT WAS NOT VISIBLE. REPORTED TO BE FOUND WHILE IN USE WITH PATIENT. NO PATIENT INJURY REPORTED. THE FAMILY HAD AN EXTRA SPARE TRACHEOSTOMY TUBE. THE CHILD WAS ABLE TO TOLERATE A DELAY IN THE REPLACEMENT OF HIS TRACHEOSTOMY TUBE. IT WAS REPORTED THAT THE CHILD WAS "UPSET/STRESSED AND REQUIRED ADDITIONAL SUPPORT SUCH AS INCREASED SUCTIONING". A1: ONE PATIENT, TWO PRODUCT MALFUNCTIONS. (B)(6) AND (B)(6) BOTH REPRESENT THE SAME PATIENT.

  Patient problems: Discomfort; Distress

  MAUDE report 17349407 ↗
• MalfunctionJul 19, 2023Material Discolored; Material Split, Cut or Torn; Material Discolored; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL. IT WAS NOTICED THERE WAS AN INCREASE IN SECRETIONS AND THE PATIENT HAS HAD A SUBSEQUENT CONSULTANT REVIEW AT THE SPECIALIST CENTER IN WHICH THE TRACHEOSTOMY BRAND WAS CHANGED.

  Patient problems: Discomfort; Distress

  MAUDE report 17349403 ↗
• MalfunctionApr 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TWO TUBES THAT WERE COLLECTED APPEARED TO HAVE BEEN CUT BY THE PARENTS ON ACCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744270 ↗
• MalfunctionApr 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBE SEEMED TO HAVE BEEN CUT BY THE PARENTS ON ACCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734412 ↗
• MalfunctionNov 18, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE UNIT IS MISSING A PART BUT CAN'T DETERMINE THE PART THAT IS MISSING. 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 15829051 ↗
• InjuryMay 1, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476332 ↗
• InjuryMay 1, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476319 ↗
• InjuryMay 1, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476308 ↗
• InjuryMay 1, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476293 ↗
• InjuryMay 1, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476287 ↗
• InjuryMay 1, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476282 ↗
• InjuryMay 1, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476278 ↗
• InjuryApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474092 ↗
• InjuryApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474091 ↗
• InjuryApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474085 ↗
• InjuryApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474081 ↗
• InjuryApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474078 ↗
• InjuryApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474077 ↗
• InjuryApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474076 ↗
• MalfunctionApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474073 ↗
• InjuryApr 30, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473345 ↗

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.