Bivona 60PFPS50Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15021312516722), received between May 1, 2024 and Aug 6, 2026 — classified as 2 injuries, 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. 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-2598-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50163981 ↗
• InjuryJun 28, 2024Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT WHEN THE PATIENT WAS UP IN CHAIR THE MACHINE ALARMED AND THE WAS PATIENT PLACED BACK ON BED AND AN EMERGENCY TRACH CHANGE OCCURRED. THE TRACH DID BREAK AT HUB AND METAL DID UNRAVEL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19636377 ↗
• InjuryMay 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN RN WAS ASSESSING A PATIENT AFTER HEARING VENT ALARM GO OFF. WHEN THE RN WENT IN TO REATTACH PATIENT TO THE VENTILATOR, RN NOTICED THAT THE SILICONE ON THE TRACH WAS COMPLETELY RIPPED APART. THIS CAUSED THE HUB NOT TO BE ATTACHED TO THE TRACH. THE RESPIRATORY THERAPIST ASSISTED WITH AN EMERGENCY TRACH CHANGE. TRACH WAS CHANGED, PATIENT TOLERATED WELL. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED AFTER THE TRACH WAS SUCCESSFULLY CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220447 ↗

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.