Bivona 75FHXL80Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15021312015690), received between Mar 4, 2020 and Mar 4, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Inflation Problem” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K081440); 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
- Inflation Problem3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2020Inflation Problem; Inflation Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® BIVONA® HYPERFLEX¿ TRACHEOSTOMY TUBE WAS REPORTED TO NOT BE HOLDING VOLUME. AIR WAS ADDED AND YET AGAIN WAS NOT HOLDING AIR. AFTER 10 MINUTES OF BEING IN USE, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9788662 ↗InjuryMar 4, 2020Inflation Problem; Inflation Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® BIVONA® HYPERFLEX¿ TRACHEOSTOMY TUBE WAS REPORTED TO NOT BE HOLDING VOLUME. AIR WAS ADDED AND YET AGAIN WAS NOT HOLDING AIR. AFTER 10 MINUTES OF BEING IN USE, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9788659 ↗InjuryMar 4, 2020Inflation Problem; Inflation Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® BIVONA® HYPERFLEX¿ TRACHEOSTOMY TUBE WAS REPORTED TO NOT BE HOLDING VOLUME. AIR WAS ADDED AND YET AGAIN WAS NOT HOLDING WATER. AFTER 10 MINUTES OF BEING IN USE, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9788657 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K081440. One submission often covers many models, so check the product and lot details in each record.
- Z-2485-2020 · May 26, 2020 · TerminatedPediatric Adjustable Flange Tracheostomy Tube Cuffless
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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