Bivona ZZ19JN80ZSC098NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517209099), received between Feb 28, 2020 and Feb 28, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2020Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem

  IT WAS REPORTED THE PATIENT'S CUFF WAS TESTED BEFORE INSERTION AND NO LEAKAGE WAS NOTICED AT THE TIME. DURING FILLING IN THE EVENING, A LEAKAGE WAS NOTICED FOR THE FIRST TIME AND WATER LEAKED INTO THE TRACHEA. THIS WAS NOTICED ON (B)(6) 2020. PER THE REPORTER, A TUBE CHANGE OUT WAS NOT COMPLETED AT THAT TIME (THIS REPORTING DECISION WAS CAPTURED UNDER THE FIRST RELATED FILE, 3012307300-2020-01603). THEN ON (B)(6) 2020, THE CUFF OF THE SAME TRACHEOSTOMY (TRACH) TUBE AS BEFORE BURST WITHOUT ANY MANIPULATION. AT THIS POINT, AN EMERGENCY TRACH CHANGE WAS DONE. DUE TO THE PATIENT BEING UNDER VENTILATED AND DUE TO THE REPORTED LEAKAGE, THE REPORTER STATED THE PATIENT HAD TO GO TO THE EMERGENCY ROOM. IT WAS ALSO NOTED THAT 12 ML OF WATER ESCAPED FROM THE CUFF AND WENT INTO THE PATIENT. FURTHERMORE, THE REPORTER ADDED THAT THE PATIENT WAS UNABLE TO USE COUGH ASSIST, SO THE HEALTH CONDITION OF THE PATIENT DETERIORATED. ADDITIONALLY, THE REPORTER STATED AN INFUSION THERAPY AND FURTHER DIAGNOSTIC MEASURES HAD TO BE TAKEN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771683 ↗
• InjuryFeb 28, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PATIENT'S CUFF WAS TESTED BEFORE INSERTION AND NO LEAKAGE WAS NOTICED AT THE TIME. DURING FILLING IN THE EVENING, A LEAKAGE WAS NOTICED FOR THE FIRST TIME AND WATER LEAKED INTO THE TRACHEA. THIS WAS NOTICED ON (B)(6) 2020. PER THE REPORTER, A TUBE CHANGE OUT WAS NOT COMPLETED AT THAT TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771678 ↗

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.