Bivona CMZ3242NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517127188), received between Jul 31, 2018 and Oct 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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.

• MalfunctionOct 13, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT UPON OPENING THE DEVICE'S STOMA SEAL WAS TOO SHORT AND NOT ACCORDING TO THE TRACHEOSTOMY TUBE TEMPLATE. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598817 ↗
• MalfunctionJul 31, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE TWO CUSTOM MADE CANNULAS WERE NOT MADE ACCORDING TO THE CUSTOMERS SPECIFICATIONS. THE CUSTOMER REQUESTED A STOMASEAL IN "2 STEPS" (PROXIMAL AND DISTAL). THE PROXIMAL ONE WAS THERE BUT NOT THE DISTAL STOMASEAL (THE ONE THAT NEEDED TOD GO DOWN TO THE CUFF). NO PATIENT COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7736796 ↗

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.