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Ciaglia Blue Rhino G12513Recalls & reported problems

Cook Incorporated · Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Tray · Class 2

All models of Ciaglia Blue Rhino (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002125131), received between Mar 9, 2016 and Mar 9, 2016 — classified as 1 injury.

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

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.

Most reported problems

Device problems

  • Kinked1

Patient problems

  • Laceration(s)1

Recent adverse event reports

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

  • InjuryMar 9, 2016Kinked; Kinked

    DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE, THERE WAS A KINK IN THE WIRE. THE USER DID NOT NOTICE THIS UNTIL DILATOR WAS OVER THE WIRE. THE PART OF THE WIRE THAT WAS KINKED GOT CAUGHT IN THE PATIENT'S STOMA CAUSING SOME LACERATION AND EXTRA BLEEDING. THE USER FINISHED THE PROCEDURE SUCCESSFULLY WITH THIS DEVICE BY REPOSITIONING THE WIRE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS OTHER THAN MINOR BLEEDING DUE TO THIS OCCURRENCE.

    Patient problems: Laceration(s)

    MAUDE report 5488798 ↗

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Sources and updates

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