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Bivona 65P050Recalls & 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
3
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15021312005998), received between Apr 26, 2017 and Feb 3, 2022 — classified as 3 malfunctions.

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

  1. 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
  • Break1
  • Defective Component1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 3, 2022Defective Component; Defective Component

    IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER CONNECTED A FILTER TO THE TRACH TUBE, USING A STRONG FORCE. THE DIAMETER OF THE PRODUCT WAS A LITTLE LARGER THAN NORMAL MAKING THE CONNECTION NOT FITTING ALL THE WAY. THE PRODUCT WAS INDWELLED IN THE PATIENT FOR ABOUT 30 DAYS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13446860 ↗
  • MalfunctionJun 28, 2017Break; Break

    IT WAS REPORTED THAT THE FLANGE OF A PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE WAS BROKEN. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR TWO WEEKS WHEN THE FAULT OCCURRED. NO INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6674919 ↗
  • MalfunctionApr 26, 2017Air Leak; Air Leak

    IT WAS REPORTED THAT DURING PATIENT USE OF THE BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE, THE DEVICE CUFF HAD AN AIR LEAK AND WAS UNABLE TO REMAIN INFLATED. THE TRACHEOSTOMY TUBE WAS REPLACED AFTER THE REPORTED ISSUE WAS OBSERVED. IT IS UNKNOWN HOW LONG THE DEVICE WAS IN PATIENT USE BEFORE THE INCIDENT WAS OBSERVED. THE DEVICE CUFF PATENCY WAS TESTED PRIOR TO PATIENT USE. THE EVENT WAS CONSIDERED RESOLVED. NO PERMANENT INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6523370 ↗

Other Tube tracheostomy and tube cuff devices

All Tube tracheostomy and tube cuff devices →

Sources and updates

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