Bivona ST16FN70NSC142NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517061093), received between Dec 1, 2019 and Mar 3, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2021Improper Flow or Infusion; Positioning Problem; Improper Flow or Infusion; Positioning Problem

  IT WAS REPORTED THAT A SMITHS MEDICAL TRACH GIVES THE PATIENT PAIN. THE TRACH TAKEN OUT AND THE PAIN WAS GONE. AFTER A WEEK, THE TRACH THAT WAS GIVING PAIN WAS INSERTED AGAIN AND THE PAIN WAS STILL THERE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11406070 ↗
• MalfunctionMar 1, 2021Ventilation Problem in Device Environment; Ventilation Problem in Device Environment

  DEVICE EVALUATION IN H10.

  Patient problems: Pain

  MAUDE report 11396660 ↗
• MalfunctionDec 1, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE CUSTOM TRACHESOTOMY TUBE FAILED TO INFLATE APPROPRIATELY. THE PATIENT HAD TO GO TO AN OUTPATIENT CLINIC IN ORDER TO HAVE ANOTHER DEVICE PLACED. NO FURTHER PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9392896 ↗
• MalfunctionDec 1, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE CUSTOM TRACHEOSTOMY TUBE FAILED TO INFLATE APPROPRIATELY. THE PATIENT HAD TO GO TO AN OUTPATIENT CLINIC IN ORDER TO HAVE ANOTHER DEVICE PLACED. NO FURTHER PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9392895 ↗

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.