Bivona CMZ2052NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517124095), received between Jun 18, 2018 and Jun 18, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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.

• InjuryJun 18, 2018Defective Component; Defective Component

  THE INCIDENT DID NOT CAUSE CLINICAL CONSEQUENCES FOR THE PATIENT AND DID NOT AGGRAVATE THE PATIENT'S CONDITION. THE CANNULA WAS REPLACED BY A CANNULA IN STOCK. THE ISSUE IS NOT RESOLVED, BUT IS STILL IN PROGRESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611391 ↗
• MalfunctionJun 18, 2018Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BIVONA TRACHEOSTOMY TUBE HAD THE INCORRECT CURVATURE OF THE CANNULA. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611379 ↗

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.