Bivona HT18ES70NSZ003NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517150933), received between Jul 18, 2018 and Apr 20, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gel 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2021Gel Leak; Gel Leak

  REPORTED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES CUSTOM MALFUNCTIONED, CAUSING A TRACHEOTOMY CHANGE. THE EVENT WAS DESCRIBED AS A PORT ON PATIENT'S TRACHE HAD ONCE AGAIN BEEN PUSHED ALL THE WAY IN. WHEN CHECKING THE WATER IN THE CUFF, THERE WAS ONLY 6.5ML, AND THE ASSUMPTION OF A POTENTIAL LEAK OCCURRED. A TRACHE CHANGE WAS CONDUCTED.

  Patient problems: Airway Obstruction

  MAUDE report 11697618 ↗
• MalfunctionApr 20, 2021Gel Leak; Gel Leak

  REPORTED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES CUSTOM MALFUNCTIONED, CAUSING A TRACHEOTOMY CHANGE. THE EVENT WAS DESCRIBED AS A PORT ON PATIENT'S TRACHE HAD ONCE AGAIN BEEN PUSHED ALL THE WAY IN. WHEN CHECKING THE WATER IN THE CUFF, THERE WAS ONLY 6.5ML, AND THE ASSUMPTION OF A POTENTIAL LEAK OCCURRED. A TRACHE CHANGE WAS CONDUCTED.

  Patient problems: Airway Obstruction

  MAUDE report 11697601 ↗
• MalfunctionJul 18, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE OF THIS CUSTOM MADE TRACHEOSTOMY TUBE, A PIN HOLE WAS OBSERVED AT THE CUFF, AND WATER BEGAN LEAKING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7700298 ↗

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.