Dolphin BT G36117Recalls & reported problems

Cook Incorporated · Dolphin BT Ciaglia Balloon-Assisted Tracheostomy Introducer Set · 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 00827002361171), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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

Material Rupture1

Patient problems

Foreign Body In Patient1
No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionFeb 27, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON OF A DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH SHILEY RUPTURED DURING USE FOR A PERCUTANEOUS TRACHEOSTOMY PROCEDURE. THE BALLOON WAS BEING USED TO FORM THE TRACHEAL STOMA WHEN IT RUPTURED IN THE PATIENT'S AIRWAY DURING INFLATION. THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE FROM THE STOMA, SO ANOTHER PHYSICIAN WAS CALLED TO ASSIST. THE DEVICE WAS THEN CUT EXTERNALLY AND REMOVED RETROGRADE UNDER DIRECT VISION. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE EVENT AND DEVICE HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient
MAUDE report 9764616 ↗

Device details

UDI-DI	`00827002361171`
Brand	Dolphin BT
Model	G36117
Catalog no.	C-PTBS-2800-PERC8
Company	Cook Incorporated
Product code	JOH · Tube tracheostomy and tube cuff
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Tracheostomy kit, single-use

A collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.

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All Tube tracheostomy and tube cuff devices →

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
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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