Bivona ZZ19KN70ZZZ006NRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15019517209983), received between Aug 10, 2022 and May 20, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  IT WAS REPORTED THAT THE PILOT-BALLOON CAME LOSE DURING TRACH-CHANGE. THE RED PILOT-BALLON CAME LOOSE DURING UNCUFFING FOR CANNULA REPLACEMENT. "THE SURFACE OF THE END OF INFLATION LINE IS SLIPPERY AND THE SUPER SLICK IS NOT REMOVED IN THE ADHESIVE AREA. THERE ARE REMAINS OF GLUE ON/IN THE PILOT BALLOON.¿ ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19355178 ↗
• MalfunctionSep 21, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER PLACED A PURCHASE ORDER OF A PRODUCT WITH AN ANESTHESIA BAG. HOWEVER, IMMEDIATELY AFTER OPENING THE PACKAGE, THEY NOTICED NO BAG WAS ENCLOSED IN IT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462132 ↗
• MalfunctionSep 21, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE ANESTHESIA BAG GOT DISCONNECTED FROM THE CONNECTOR. NO WHITE TAPE WAS WOUND OVER THE CONNECTOR. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462126 ↗
• MalfunctionSep 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THE AIR PRESSURE WITHIN THE CIRCUIT DID NOT REACH THE SPECIFIED VALUE. THEY SUSPECTED AIR LEAK OCCURRED IN THE PRODUCT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461080 ↗
• MalfunctionSep 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED AIR WAS LEAKING FROM THE PRODUCT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461073 ↗
• MalfunctionSep 21, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER FOUND A TORN HOLE IN THE PRODUCT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461057 ↗
• MalfunctionSep 13, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE EYELET IS NOT REINFORCED AND THERE IS NO SUPERSLICK SURFACE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410144 ↗
• MalfunctionSep 13, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A QUALITY CHECK, THE RED WING PILOT PORT DETACHED FROM THE HOSE. THE DEVICE WAS REPAIRED BY REMOVING THE SUPERSLICK AT THE GLUING AREA AND GLUING IT BACK ON WITH SILICONE DUE TO THE PATIENT NEEDING THE TUBES. NO PATIENT INJURY WAS REPORTED PHOTOS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409675 ↗
• MalfunctionAug 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PRIOR TO USE, IT WAS NOTICED THAT THE NECK FLANGE IS NOT PROPERLY GLUED AND GAPS ARE ABLE TO BE VISUALIZED. CUSTOMER REPORTED THAT THE GAPS SEEM TO BE FILLED WITH "SUPERSLICK". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204566 ↗

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.