Ciaglia Blue Rhino G12565Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002125650), received between Feb 20, 2018 and Sep 2, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (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
- Fail-Safe Did Not Operate1
- Folded1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2020Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10483254 ↗MalfunctionApr 22, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8536928 ↗MalfunctionFeb 20, 2018Folded; Folded
THE CUSTOMER REPORTED THAT WHEN THE CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER WAS INITIALLY PLACED ONTO THE STERILE FIELD, THE DEVICE WAS INSPECTED AND FOUND TO BE INTACT. DURING PLACEMENT THE DEVICE HAD FOLDED AND WAS MALFORMED IN SHAPE. IT WAS ONLY DURING INSERTION THAT THE PRODUCT PROBLEM WAS NOTED. A NEW PRODUCT WAS OPENED AND INSERTED SUCCESSFULLY, AND PLACED WITHOUT DIFFICULTY. THE CUSTOMER CONFIRMED THAT NO ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM, AND NO ADDITIONAL PROCEDURES WERE NECESSITATED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION AS IT WAS NOTED TO HAVE BEEN THROWN AWAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7284386 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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