Bivona XT16JS65NSC006SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517075915), received between Aug 9, 2018 and Aug 9, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 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.

• InjuryAug 9, 2019Break; Fracture; Break; Fracture

  INFORMATION WAS RECEIVED THAT INCIDENT OCCURRED DURING ROUTINE TRACH CARE, WHICH INCLUDES CLEANING OF THE TRACHEOSTOMY SITE. A TRACHEOSTOMY TUBE CHANGE OUT OCCURRED IMMEDIATELY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8879800 ↗
• MalfunctionAug 9, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT THE BIVONA TRACHEOSTOMY TUBE OVER INFLATED ON ONE SIDE OF THE BALLOON. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770052 ↗

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.