Bivona 67NFP25Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Bivona (469)
Data updated Oct 18, 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 10351688518736), received between Oct 11, 2022 and Oct 11, 2022 — 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.
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.
Recalls naming this device
- May 29, 2024Class IOpen, 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-2608-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Inflation Problem1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2022Inflation Problem; Inflation Problem
IT WAS REPORTED THAT A 12-WEEK-OLD INFANT WITH A TRACHEOSTOMY TUBE FOR VOCAL CORD DYSKINESIA AND SEVERAL FAILED EXTUBATIONS, EXPERIENCED A TUBE FAILURE. DURING A TUBE CHANGE, THE CUFF OF THE TUBE DID NOT INFLATE DESPITE A KNOWN AND MASTERED PREPARATION OF THE DEVICE BY THE PROFESSIONALS BEFORE ITS INSTALLATION. THE DEVICE WAS UNUSABLE. THE CUSTOMER WAS CONCERNED WITH THE RISK OF NOT BEING ABLE TO PROTECT THE PATIENT'S AIRWAYS FROM VOMITING. THE ISSUE WAS RESOLVED WITH A CHANGE OF DEVICE.
Patient problems: Airway Obstruction
MAUDE report 15583907 ↗
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 · each recall links to the FDA recall notice
- 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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