Bivona 60NFPS30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15021312516685), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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-2594-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2023Material Puncture/Hole; Material Protrusion/Extrusion; Material Puncture/Hole; Material Protrusion/Extrusion

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE TUBE HAD BEEN IN PATIENT USE WHEN THE ERROR WAS NOTED. THE TUBE WAS ABOUT TO BE REPASSED INTO THE PATIENT AFTER COMING OUT. IT HAD BEEN CLEANED 1 WEEK PRIOR. THE PATIENT DID EXPERIENCE SOME AIRWAY DETERIORATION INCLUDING BLEEDING WHICH REQUIRED AN INTENSIVE CARE STAY, HOWEVER, THE REPORTER WAS UNSURE AS TO WHETHER THIS WAS DUE TO THIS TUBE DIRECTLY OR OTHER EXTERNAL FACTORS.

  Patient problems: Insufficient Information; Upper Respiratory Tract Injury

  MAUDE report 17211065 ↗

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.