Bivona 60PFSS50Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15021312516807), received between Mar 9, 2023 and May 8, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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-2601-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT¿S OXYGEN SATURATION MONITOR ALARMED AT 82%, AND IT WAS IDENTIFIED THAT THE TRACHEOSTOMY TUBE HAD BECOME DISLODGED AND THE FLANGE HAD SPLIT. A NEW AIRWAY WAS SECURED, AND THE EMERGENCY ALGORITHM WAS FOLLOWED TO STABILIZE THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND ADVERSE HARM REPORTED. THE EVENT HAS BEEN REPORTED TO THE REGULATORY AGENCY (NCA REFERENCE NUMBER: (B)(4); MHRA REF: (B)(4).

  Patient problems: Respiratory Insufficiency

  MAUDE report 25125405 ↗
• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED THAT THE CUSTOMER HAD A DECANNULATION DUE TO A BREAK IN THE TRACH FLANGE "(LEFT HOLE)". THIS TRACH WAS INSERTED ON THE RESIDENT ON (B)(6) 2023. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16513216 ↗

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.