Bivona 75HA80Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15021312013856), received between Dec 30, 2020 and Mar 12, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K081440); 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.

• MalfunctionMar 12, 2026Inflation Problem

  IT WAS STATED THAT IN THE OPERATING ROOM (OR), WHILE PLACING THE TUBE AND INFLATING THE CUFF ON THE PATIENT, THE CUFF APPEARED TO BE ADHERED AND COULD NOT BE INFLATED. AIR ABNORMALLY REMAINED IN THE PILOT BALLOON AND HAD DIFFICULTY ENTERING THE CUFF, AND RESISTANCE WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586490 ↗
• InjuryJan 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE WAS FOUND LEAKING WHILE IT WAS PUT INTO AN ICU NEURO PATIENT. A TRACH CHANGE RESOLVED THE ISSUE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16194841 ↗
• InjuryJun 10, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITH MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT HYPERFLEX WAS LEAKING AND REQUIRED TRACH CHANGE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978606 ↗
• InjuryDec 30, 2020Leak/Splash; Leak/Splash

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT HYPERFLEX MALFUNCTIONED. WHEN THE TRACH TUBE WAS USED, IT WAS FOUND THAT THE CUFF WAS LEAKING. CUSTOMER RESPONSE REVEALED AN TRACHEOSTOMY TUBE CHANGE OUT WAS REQUIRED. FILE NOW SEROUS INJURY REPORTABLE. AS UNKNOWN IF NEW TRACHEOSTOMY VERSES LONG TERM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11098796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081440. One submission often covers many models, so check the product and lot details in each record.

• Z-2485-2020 · May 26, 2020 · Terminated
  Pediatric Adjustable Flange Tracheostomy Tube Cuffless