Bivona FT14HN70NSC296NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688741066), received between Nov 8, 2022 and Jan 18, 2024 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJan 18, 2024Fluid/Blood Leak; Unintended Deflation; Fluid/Blood Leak; Unintended Deflation

  IT WAS REPORTED THAT THEY "PICKED UP A DEFECTIVE TRACH FROM A PATIENT". THE TRACH WOULD NOT HOLD WATER. CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT; HOWEVER PATIENT INITIALS AND A DOB WERE PROVIDED. CUSTOMER REPORTED NO PATIENT OR CLINICAL INJURY OCCURRED. THE OUTCOME OF EVENT WAS "ONGOING NEED PT'S SPECIFIC SPECIAL TRACHS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536565 ↗
• InjuryNov 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TRACH WAS NOT HOLDING FLUID AFTER TWO HOURS. ADDITIONALLY, IT WAS REPORTED THAT "THE TRACH IS ALWAYS TESTED BEFORE PUTTING IT IN AND IT SEEMED TO BE FINE WITH NO LEAKS. THEY THEN DEFLATED IT TO PUT IN AND THEN IN OVER ABOUT 2-4HRS THEY NOTICED 2ML SALINE THAT WAS DUMPED IN HIS LUNGS. THE INCIDENT DID CAUSE HARM. IT MADE THE PATIENT NOT FEEL GOOD FOR A COUPLE OF DAYS, MUSCLE STRENGTH TOTALLY GONE, MORE SECRETIONS AND GUNK IN HIS LUNGS."

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 15754950 ↗

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.