Bivona FT21GN35NGE965NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517274011), received between Jan 21, 2022 and Jun 12, 2023 — classified as 1 injury, 2 malfunctions.

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 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.

• InjuryJun 12, 2023Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED: THE TRACH WAS IN A NICU PATIENT, AND THE CUFF HAD A MICRO LEAK SOON AFTER PLACED IN PATIENT. THEY CHANGED IT OUT TO THE ONLY SPARE TRACH. WHILE AWAITING THE NEW ONE TO ARRIVE THEY HAD TO CHANGE OUT. THEY CLEAN THE BIVONA AND ONCE DRY THEY PLACED IT BACK IN THE INFANT. THEY DID REMEMBER WHICH PATIENT THIS HAPPENED TO KNOW THAT IT HAS BEEN THIS LONG. THEY HAD NUMEROUS TRACH BABIES IN THE PAST 8 MONTHS. THEY RECENTLY HAD ANOTHER WITH A LEAK.

  Patient problems: Insufficient Information

  MAUDE report 17113006 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT ONE OF THE TRACHS WAS USED FOR THE FIRST WEEK AND IT'S ALREADY COMPLETELY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067474 ↗
• MalfunctionJan 21, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOM TRACH HAD A HOLE IN THE CUFF RIGHT OUT THE PACKAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314704 ↗

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.