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Bivona 850180Recalls & 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15021312006797), received between Sep 22, 2022 and Sep 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K083641, K913859); 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.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 22, 2022Break; Break

    IT WAS REPORTED DURING PRE-TEST, WHILE EMPTYING THE CUFF AND TURNING THE 3-WAY CRANE, THE BRACKET BROKE THE CUFF AND WATER SPILLED OUT. NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15464793 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K913859. One submission often covers many models, so check the product and lot details in each record.

  • Z-0205-2024 · Aug 22, 2023 · Open, Classified
    Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
  • Z-2946-2020 · Aug 28, 2020 · Terminated
    Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
  • Z-1465-2017 · Feb 9, 2017 · Terminated
    Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
  • Z-0339-2007 · Aug 31, 2006 · Terminated
    Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
  • Z-0046-2007 · Aug 11, 2006 · Terminated
    Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.

Other Tube tracheostomy and tube cuff devices

All Tube tracheostomy and tube cuff devices →

Sources and updates

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