Bivona FT21IN50NGF104NRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Bivona (469)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517281057), received between May 24, 2022 and May 24, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TRACH WAS DEFLATING AFTER INSERTION. DUE TO THIS, THE TRACH WAS REMOVED FROM THE PATIENT TO BE TESTED. ONCE THE TRACH WAS REMOVED, IT WAS FILLED AND LEFT OUT TO SEE IF IT WOULD STAY INFLATED. IT DID NOT. NO PATIENT HARM WAS REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14492838 ↗InjuryMay 24, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TRACH WAS DEFLATING AFTER INSERTION. DUE TO THIS, THE TRACH WAS REMOVED FROM THE PATIENT TO BE TESTED. ONCE THE TRACH WAS REMOVED, IT WAS FILLED AND LEFT OUT TO SEE IF IT WOULD STAY INFLATED. IT DID NOT. NO PATIENT HARM WAS REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14492654 ↗
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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