Bivona 67P025Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15021312006247), received between Mar 29, 2019 and Mar 29, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Inflation Problem” (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-2610-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2019Inflation Problem; Inflation Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY TUBE CUFF BALLOON WOULD NOT INFLATE WHILE IN USE WITH A NICU PATIENT. SUBSEQUENTLY, A TRACHEOSTOMY CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8465784 ↗
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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