Bivona 60NFP35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15021312014730), received between Mar 15, 2021 and Mar 16, 2021 — classified as 2 malfunctions.

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

• MalfunctionMar 16, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT THERE WAS A TINY HOLE IN THE BOTTOM OF THE FLEXTEND PORTION OF THE BIVONA TRACHEOSTOMY TUBE. THIS WAS NEAR THE OUTER HUB, AND WAS EXPOSING THE VIEWING OF THE WIRE IN THE FLEXTEND PORTION. THIS PRODUCT FAULT WAS NOTICED AFTER A WHISTLING SOUND WAS HEARD COMING FROM THE CHILD. THE VENTILATOR, WHICH WAS ALSO ON, WAS ALARMING. THE PATIENT'S MOTHER TRIED TO SUCTION THE CHILD'S TUBE BUT SHE WAS UNABLE TO INSERT THE SUCTION CATHETER TO THE NEEDED SUCTION DEPTH. THE MOTHER THOUGHT THAT THERE WAS A BLOCKAGE. AFTER SUSPECTING THIS, THE MOTHER PERFORMED A TRACHEOSTOMY TUBE CHANGE. NO PATIENT INJURY, OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494541 ↗
• MalfunctionMar 15, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT THERE WAS A TINY HOLE IN THE BOTTOM OF THE FLEXTEND PORTION OF THE BIVONA TRACHEOSTOMY TUBE. THIS WAS NEAR THE OUTER HUB, AND WAS EXPOSING THE VIEWING OF THE WIRE IN THE FLEXTEND PORTION. THIS PRODUCT FAULT WAS NOTICED AFTER A WHISTLING SOUND WAS HEARD COMING FROM THE CHILD. THE VENTILATOR, WHICH WAS ALSO ON, WAS ALARMING. THE PATIENT'S MOTHER TRIED TO SUCTION THE CHILD'S TUBE BUT SHE WAS UNABLE TO INSERT THE SUCTION CATHETER TO THE NEEDED SUCTION DEPTH. THE MOTHER THOUGHT THAT THERE WAS A BLOCKAGE. AFTER SUSPECTING THIS, THE MOTHER PERFORMED A TRACHEOSTOMY TUBE CHANGE. NO PATIENT INJURY, OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488493 ↗

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.