Ciaglia Blue Rhino G2 G55652Recalls & reported problems
Cook Incorporated · Ciaglia Blue Rhino G2 Percutaneous Tracheostomy Introducer Set · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002556522), received between Mar 26, 2018 and Mar 28, 2018 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Most reported problems
Device problems
- Leak/Splash2
- Inaccurate Delivery1
- Structural Problem1
Patient problems
- Hypoventilation2
- No Code Available2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2018Leak/Splash
IT WAS REPORTED THAT AFTER THE CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE WAS PLACED, IT WOULD NOT PROPERLY VENTILATE DUE TO A CUFF LEAK. ANOTHER CANNULA WAS PLACED TO COMPLETE THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7378034 ↗InjuryMar 27, 2018Structural Problem
THE COMPLAINANT REPORTED THAT A PERCUTANEOUS TRACHEOSTOMY WAS PERFORMED USING A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE AND THE PATIENT COULD NOT BE VENTILATED. THE INNER WOERTHER TUBE COULDN'T BE BLOCKED BECAUSE THE CANNULA HAD A HOLE. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE TO REMOVE THE CANNULA AND PLACE A NEW DEVICE. THERE WERE NO ADDITIONAL ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: Hypoventilation; No Code Available
MAUDE report 7373585 ↗InjuryMar 26, 2018Leak/Splash; Inaccurate Delivery
IT WAS REPORTED THAT THE AFTER THE CANNULA OF A VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE WAS INSERTED, IT HAD AN APPARENT CUFF LEAK AND WOULD NOT ALLOW PROPER VENTILATION. ANOTHER CANNULA WAS PLACED SUCCESSFULLY, BUT IT WAS FOUND TO BE DELIVERING INSUFFICIENT OXYGEN THE FOLLOWING DAY, SO IT WAS REPLACED WITH ANOTHER COMPANY¿S DEVICE. THERE WERE NO INJURIES REPORTED ASIDE FROM THIS ADDITIONAL PROCEDURE.
Patient problems: Hypoventilation; No Code Available
MAUDE report 7370035 ↗
Other Tube tracheostomy and tube cuff devices
- Shiley 8CN85HCovidien LP · Tube tracheostomy and tube cuff1 recall2 deaths354 reports
- 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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