Bivona 85P045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15021312007022), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K083641, K913859); 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.

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.

• MalfunctionJan 7, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE PILOT LINE OF A PEDIATRIC 4.5 SMITHS MEDICAL BIVONA FOME CUFFED TRACH TUBE WAS FOUND TO HAVE A SLIT IN IT WHILE IN SITU IN A PEDIATRIC PATIENT. SLIT WAS IMMEDIATELY NEXT TO THE RED PILOT VALVE. THIS TRACH WAS NEW AND INSERTED ON NOV 24TH. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11129397 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K913859. 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-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.
• Z-0339-2007 · Aug 31, 2006 · Terminated
  Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
• Z-0046-2007 · Aug 11, 2006 · Terminated
  Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.