Dolphin BT G23548Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002235489), received between Sep 14, 2017 and Sep 20, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
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
- Burst Container or Vessel2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2017Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, DURING THE PRESSURIZATION OF THE BALLOON CONTAINED IN THE DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE, THE BALLOON BURST. THE CUSTOMER FURTHER ELABORATED THAT THERE WAS NO INJURY TO THE PATIENT, NO PARTS OF THE DEVICE REMAINED INSIDE THE CAVITY OF THE PATIENT, AND THERE WERE NO PATIENT ADVERSE EFFECTS DUE TO THE OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED BY THE REPORTER, AND THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6879850 ↗MalfunctionSep 14, 2017Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, DURING THE PRESSURIZATION OF THE BALLOON CONTAINED IN THE DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE, THE BALLOON BURST. THE CUSTOMER FURTHER ELABORATED THAT THERE WAS NO INJURY TO THE PATIENT, NO PARTS OF THE DEVICE REMAINED INSIDE THE CAVITY OF THE PATIENT, AND THERE WERE NO PATIENT ADVERSE EFFECTS DUE TO THE OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED BY THE REPORTER, AND THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6866487 ↗
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- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 7CN80RCovidien LP · Tube tracheostomy and tube cuff2 recalls148 reports
- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
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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