Bivona ZU24KN80NSC170NRecalls & reported problems
Icu Medical, Inc. · ZU24KN80NSC170N Bivona DI Template: Non-Adjustable-Non-Wired-Non-Sterile · Class 2
All models of Bivona (469)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887709139777), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2025Contamination; Gas/Air Leak; Contamination; Gas/Air Leak
IT WAS REPORTED THAT MOLD STAINS WERE FORMED UNDER THE CONNECTOR/SWIVEL. THE PRODUCT WAS WASHED ACCORDING TO THE INSTRUCTIONS WITH A MILD DETERGENT SOLUTION AND FINALLY RINSED WITH NACL. THE CANNULA WAS CHANGED SEVERAL TIMES A WEEK, SO ONE CANNULA WAS NOT IN USE FOR SEVERAL DAYS AT A TIME. THE CONNECTORS ON THE LATEST CANNULAS ARE ALSO DIFFERENT FROM PREVIOUS ONES AND HAVE ALREADY CAUSED AIR LEAKS. THERE WAS NO IMMEDIATE DANGER TO THE PATIENT, HOWEVER MOLD SPORES IN THE RESPIRATORY TRACT COULD HAVE LED TO A SERIOUS RESPIRATORY INFECTION REQUIRING TREATMENT. THERE WAS PATIENT INVOLVEMENT. SAMPLE PHOTO HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23053684 ↗
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 · TerminatedCustom 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.
Other Tube tracheostomy and tube cuff devices
- Shiley 8CN85HCovidien LP · Tube tracheostomy and tube cuff1 recall2 deaths354 reports
- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 7CN80RCovidien LP · Tube tracheostomy and tube cuff2 recalls148 reports
- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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