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Dolphin BT G49507Recalls & reported problems

Cook Incorporated · Dolphin BT Ciaglia Balloon-Assisted Tracheostomy Introducer Tray · Class 2

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 00827002495074), received between Mar 27, 2018 and Mar 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 27, 2018Fluid/Blood Leak

    THE COMPLAINANT REPORTED THAT A POP SOUND WAS HEARD AND SALINE BEGAN TO LEAK FROM THE BALLOON AS SOON AS THE BALLOON WAS INFLATED TO 11 ATM. THE USER REMOVED THE BALLOON AND USED A FINGER TO CONFIRM IF ADEQUATE DILATION WAS ACHIEVED. THE PROCEDURE CONTINUED AS INTENDED AND WAS SUCCESSFUL. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7374832 ↗

Other Tube tracheostomy and tube cuff devices

All Tube tracheostomy and tube cuff devices →

Sources and updates

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