Bivona 60HA35Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Bivona (469)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15021312013702), received between Nov 25, 2019 and Jan 23, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Defective Device1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2025Disconnection; Disconnection
IT WAS REPORTED THAT DURING THE REPLACEMENT OF THE ADJUSTABLE TRACHEOTOMY CANNULA, THE INTERNAL FRAMEWORK CAME LOOSE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21223808 ↗MalfunctionNov 11, 2024Break; Break
IT WAS REPORTED THAT WHEN CHANGING THE TRACHEOSTOMY ADJUSTABLE CANNULA, THE INTERNAL ARMATURE WAS BROKEN. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652106 ↗MalfunctionNov 25, 2019Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA HYPERFLEX TRACHEOSTOMY TUBE HAD A NECK PLATE ON UPSIDE DOWN. AS A RESULT, THE PATIENT WAS NOT PROPERLY VENTILATED, AND A NEW TRACHEOSTOMY WAS INSERTED. IT WAS FURTHER REPORTED THAT THE USER NOTICED UNSPECIFIED PROBLEMS WITH TWO ADDITIONAL BIVONA HYPERFLEX TRACHEOSTOMY TUBES. THESE UNSPECIFIED PRODUCT ISSUES WERE IDENTIFIED PRIOR TO PATIENT USE.
Patient problems: No Information
MAUDE report 9371228 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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