Bivona 60NFPS35Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15021312516692), received between Jan 29, 2019 and May 18, 2026 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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-2594-2024 · 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.

• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT THE TRACH TUBE SNAPPED WHILE INSERTED INSIDE THE PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204399 ↗
• MalfunctionDec 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS STATED THAT THE PARENT WAS USING THE DEVICE AND NOTICED THAT THE FLANGE WAS STARTING TO SPLIT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758350 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A BREAKAGE AT THE LOWER EDGE AND THE SPIRAL WAS EXPOSED. THE INCIDENT OCCURRED AT THE PATIENT`S HOUSE. THERE IS UNKNOWN PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756458 ↗
• InjuryApr 21, 2023Break; Break

  IT WAS REPORTED THAT THE FLANGE HOLES THAT HOLD THE TIES BROKE AND THE TRACHY CAME OUT WITHOUT BEING NOTICED. THE CHILD WENT BLUE BEFORE EMERGENCY CHANGE COULD TAKE PLACE. NO INJURY REPORTED. THE LOT NUMBER WAS UNKNOWN.

  Patient problems: Respiratory Insufficiency

  MAUDE report 16789990 ↗
• InjuryMar 20, 2023Break; Break

  IT WAS REPORTED THAT THE RIGHT-SIDE FLANGE SPLIT ON TRACHEOSTOMY TUBE. ADDITIONAL INFORMATION WAS RECEIVED PROVIDING MORE DETAILS. THE ISSUE WAS DISCOVERED WHILE IN USE WITH THE PATIENT. THE CUSTOMER WAS DOING THE TAPES AND NOTICED THAT THE FLANGE HAD SPLIT ON THE RIGHT SIDE. THE CUSTOMER DID EMERGENCY TUBE CHANGE. SECURED NEW TUBE AND ESCALATED TO THE WARD AND WHAT HAD HAPPENED. THE CUSTOMER CAME AND COLLECTED A NEW SPARE TUBE AND BROUGHT IN THE BROKEN ONE. THIS HAPPENED WHEN THE PATIENT WAS ON HOME LEAVE FOR THE WEEKEND. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16576560 ↗
• MalfunctionJun 15, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE TUBE NOTED TO HAVE DAMAGE TO FLANGE ON INSPECTION PRIOR TO ITS 3RD USE. TUBE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14699648 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD DAMAGE TO THE FLANGE DURING ITS SECOND USE. THE TUBE WAS IMMEDIATELY REMOVED FROM USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691766 ↗
• InjuryAug 2, 2019Crack; Material Separation; Crack; Material Separation

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE TO A SMITHS MEDICAL BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE CRACKED AND SEPARATED FROM THE TUBE. THE TRACH TUBE WAS CHANGED OUT AND RETURNED FOR INVESTIGATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857058 ↗
• InjuryAug 2, 2019Crack; Material Separation; Crack; Material Separation

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE TO A SMITHS MEDICAL BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE CRACKED AND SEPARATED FROM THE TUBE. THE TRACH TUBE WAS CHANGED OUT AND RETURNED FOR INVESTIGATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8856998 ↗
• InjuryAug 2, 2019Crack; Material Separation; Crack; Material Separation

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE TO A SMITHS MEDICAL BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE CRACKED AND SEPARATED FROM THE TUBE. THE TRACH TUBE WAS CHANGED OUT AND RETURNED FOR INVESTIGATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8856931 ↗
• InjuryAug 2, 2019Crack; Material Separation; Crack; Material Separation

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE TO A SMITHS MEDICAL BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE CRACKED AND SEPARATED FROM THE TUBE. THE TRACH TUBE WAS CHANGED OUT AND RETURNED FOR INVESTIGATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8856818 ↗
• InjuryAug 2, 2019Crack; Material Separation; Crack; Material Separation

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE TO A SMITHS MEDICAL BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE CRACKED AND SEPARATED FROM THE TUBE. THE TRACH TUBE WAS CHANGED OUT AND RETURNED FOR INVESTIGATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8856711 ↗
• MalfunctionMay 28, 2019Break; Fracture; Detachment of Device or Device Component; Material Integrity Problem; Break; Fracture; Detachment of Device or Device Component; Material Integrity Problem

  INFORMATION WAS RECEIVED THAT THE FLANGE OF A SMITHS MEDICAL BIVONA UNCUFFED NEONATAL FLEXTEND PLUS STRAIGHT FLANGE TRACHEOSTOMY TUBE CRACKED AND SEPARATED FROM THE TUBE. THERE WERE NO ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8647831 ↗
• InjuryJan 29, 2019Fungus in Device Environment; Fungus in Device Environment

  INFORMATION WAS RECEIVED THAT DURING A REGULAR TRACHEOSTOMY CHANGE OUT, A SMITHS MEDICAL BIVONA FLEXTEND TRACHEOSTOMY TUBE WAS NOTED TO HAVE BLACK MOLD WHERE THE TUBE CONNECTS TO THE FLUX. PATIENT WAS GIVEN ANTIBIOTICS BOTH ORALLY AND THROUGH AN IV.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286689 ↗

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.