Bivona FT23AN45NSF976NRecalls & 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
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 15019517329131), received between Aug 31, 2023 and Nov 1, 2023 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (16 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.
Reports received per month
Most reported problems
Device problems
- Microbial Contamination of Device16
- Contamination13
Patient problems
- Insufficient Information16
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2023Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THERE WAS "SOME DEBRIS AND POSSIBLE MOLD IN/ON THE CUSTOM TRACHEOSTOMY". PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18049533 ↗MalfunctionNov 1, 2023Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THERE WAS "SOME DEBRIS AND POSSIBLE MOLD IN/ON THE CUSTOM TRACHEOSTOMY". PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18049452 ↗MalfunctionNov 1, 2023Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THERE WAS "SOME DEBRIS AND POSSIBLE MOLD IN/ON THE CUSTOM TRACHEOSTOMY". PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18049444 ↗MalfunctionSep 1, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17669822 ↗MalfunctionSep 1, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17669815 ↗MalfunctionSep 1, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17669795 ↗MalfunctionSep 1, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17669794 ↗MalfunctionSep 1, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17669783 ↗MalfunctionSep 1, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17669747 ↗MalfunctionSep 1, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17669740 ↗MalfunctionAug 31, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17667264 ↗MalfunctionAug 31, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17667263 ↗MalfunctionAug 31, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17667262 ↗MalfunctionAug 31, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17667261 ↗MalfunctionAug 31, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17667259 ↗MalfunctionAug 31, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device
IT WAS REPORTED THAT AFTER A WEEK OF USE, THE DEVICE WAS FILLED WITH MOLD. IT WAS STATED THAT THERE WAS SOMETHING TRAPPED, BUT IT WAS "BLACK GOOEY, HAIRY". CUSTOMER HAS CONFIRMED THE DEVICES WERE BEING STERILIZED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17667258 ↗
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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