Bivona 60PFS55Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15021312005899), received between Feb 27, 2020 and Apr 3, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 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-2599-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT A CUSTOMER HAD A TRACHEOSTOMY TUBE SPLIT WHILE IN USE WITH THEIR PATIENT. THERE WAS A MEDICAL INTERVENTION REQUIRED, PARENTS AND CARES HAD TO REMOVE AND REPLACE THE TRACHEOSTOMY TUBE THAT SPLIT WITH A NEW ONE. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 16669122 ↗
• InjuryApr 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT A CUSTOMER HAD A TRACHEOSTOMY TUBES SPLIT WHILE IN USE WITH A PATIENT. THERE WAS A MEDICAL INTERVENTION REQUIRED, PARENTS AND CARES HAD TO REMOVE AND REPLACE THE TRACHEOSTOMY TUBE THAT SPLIT WITH A NEW ONE. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 16668747 ↗
• InjuryMay 30, 2020Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A PATIENTS MOTHER WAS GOING TO CHANGE TAPES WHEN SHE NOTICED THAT THE EYELET LOOKS LIKE IT IS GOING TO SNAP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10103720 ↗
• InjuryMar 6, 2020Break; Break

  INFORMATION WAS RECEIVED THAT DURING A ROUTINE TRACHEOSTOMY TUBE CHANGE OF A SMITHS MEDICAL BIVONA TRACHEOSTOMY NEO FLEXTEND PLUS, THE RIGHT EYELET WAS FOUND TO BE BROKEN. THE TUBE WAS CHANGED IMMEDIATELY, AND NO PATIENT ADVERSE EFFECTS OCCURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9801414 ↗
• InjuryFeb 27, 2020Break; Break

  INFORMATION WAS RECEIVED THAT DURING A ROUTINE TRACH TIE CHANGE, THE FLANGE ON A SMITHS MEDICAL BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE WAS FOUND TO BE BROKEN. A TRACH CHANGE WAS DONE TO RESOLVE THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767260 ↗

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.