Bivona CMZ2082NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517111569), received between Apr 17, 2018 and Apr 17, 2018 — classified as 2 malfunctions.

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

• MalfunctionApr 17, 2018Air Leak; Inflation Problem; Air Leak; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE BALLOON OF THIS TRACHEOSTOMY TUBE WOULD NOT INFLATE PROPERLY AS THERE WAS AN AIR LEAK. THE TRACHEOSTOMY TUBE WAS REMOVED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7437812 ↗
• MalfunctionApr 17, 2018Air Leak; Inflation Problem; Air Leak; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE BALLOON OF THIS TRACHEOSTOMY TUBE WOULD NOT INFLATE PROPERLY AS THERE WAS AN AIR LEAK. THE TRACHEOSTOMY TUBE WAS REMOVED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7437811 ↗

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.