Bivona 60NFP30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15021312014723), received between May 25, 2018 and May 2, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE HAD JUST BEEN CHANGED THE DAY BEFORE. THE DEVICE WAS ON IT'S THIRD USE. THE DEVICE LOOKED TO BE INTACT ON INSPECTION PRIOR TO INSERTION, AND IT WAS FOUND DAMAGED WITHIN 24 HOURS. THE DEVICE WAS CHANGED AGAIN AS SOON AS THE DAMAGE WAS DISCOVERED. A PICTURE WAS SENT IN FROM THE CUSTOMER SHOWING POSSIBLE CHIPPING OF THE TRACH TIES. EXACT "DAMAGE" HAS NOT BEE COMMUNICATED.

  Patient problems: Insufficient Information

  MAUDE report 16857746 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER REPORTED A DAMAGE TRACHEOSTOMY TUBE. THE TRACH HAD BEEN STERILIZED ONCE PREVIOUSLY AND WAS BEING CHANGED TO THE END OF ITS SECOND USE. HAD BEEN IN PLACE FOR ONE MONTH WHEN THE DAMAGE WAS NOTICED BY THE PATIENT'S MOTHER. THE DEVICE WAS CHANGED TO A TRACH THAT HAD BEEN STERILIZED TWICE, THIS WAS IT'S THIRD USE. THE TRACH WAS CHECKED PRIOR TO INSERTION AND FOUND TO BE SUFFICIENT FOR PLACEMENT. A PICTURE WAS SENT IN FROM THE CUSTOMER SHOWING POSSIBLE CHIPPING OF THE TRACH TIES. EXACT "DAMAGE" HAS NOT BEE COMMUNICATED.

  Patient problems: Insufficient Information

  MAUDE report 16856098 ↗
• InjuryMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT THE FLEXTEND PORTION OF THE TRACHEOSTOMY TUBE WAS FOUND TO BE KINKED. THE FAULT WAS NOTICED WHEN THERE WAS INCREASED RESISTANCE DURING SUCTIONING. ONCE THE TUBE WAS REMOVED, A "CLEAR PINCH" WAS NOTICED. THE TRACHEOSTOMY TUBE WAS REPLACED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546707 ↗

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.