Bivona FT18JN40NSE055NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517167894), received between Dec 13, 2018 and Dec 13, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K923878); 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 18, 2026.

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.

• InjuryDec 13, 2018Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA CUSTOM TRACHEOSTOMY TUBE CUFF LEAKED WHILE IN USE WITH A PICU PATIENT. SUBSEQUENTLY, RESPIRATORY WAS CALLED TO THE BEDSIDE TO PERFORM AN EMERGENT TRACHEOSTOMY (TRACH) CHANGE OUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8162899 ↗
• InjuryDec 13, 2018Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA CUSTOM TRACHEOSTOMY TUBE CUFF LEAKED WHILE IN USE WITH A PICU PATIENT. SUBSEQUENTLY, RESPIRATORY WAS CALLED TO THE BEDSIDE TO PERFORM AN EMERGENT TRACHEOSTOMY (TRACH) CHANGE OUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8162895 ↗
• InjuryDec 13, 2018Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA CUSTOM TRACHEOSTOMY TUBE CUFF LEAKED WHILE IN USE WITH A PICU PATIENT. SUBSEQUENTLY, THE DEFECTIVE TRACHEOSTOMY (TRACH) TUBE WAS LEFT IN UNTIL RESPIRATORY WAS CALLED TO THE BEDSIDE TO PERFORM AN EMERGENT TRACH CHANGE OUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8162893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.