Bivona 65P045Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Bivona (469)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15021312005981), received between Oct 20, 2017 and Oct 19, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Air Leak” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- May 29, 2024Open, Classified
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Z-2604-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Air Leak1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Respiratory Distress1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE DEVICE WAS FOUND THAT THE INNER PACKAGE WAS OPENED WHEN THE TRACH WAS BEING TAKEN OUT OF THE BOX. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15635604 ↗InjuryOct 20, 2017Air Leak; Air Leak
IT WAS REPORTED THAT AN AIR-LEAK WAS NOTED TO A SMITHS MEDICAL BIVONA® AIRE-CUF® TRACHEOSTOMY TUBE AFTER PLACEMENT. SUBSEQUENTLY, IT WAS REQUIRED THAT AN "EMERGENT TRACHEOSTOMY CHANGE OUT" WAS PERFORMED. THE PATIENT HAD BEEN PREVIOUSLY TRANSFERRED TO THE INTENSIVE CARE UNIT FOR DETERIORATING RESPIRATORY STATUS REQUIRING THE PREVIOUS TRACHEOSTOMY TO BE CHANGED TO THE SMITHS PRODUCT. UPON FILLING THE CUFF WITH AIR, AN AIR-LEAK WAS NOTED, MAKING THE CUFF'S AIR PRESSURE ZERO. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: Respiratory Distress
MAUDE report 6965718 ↗
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 · each recall links to the FDA recall notice
- 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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