Ciaglia Blue Rhino G2 G53179Recalls & reported problems
Cook Incorporated · Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Tray · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002531796), received between Mar 28, 2018 and Sep 16, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (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
- Device Slipped1
- Leak/Splash1
- Material Puncture/Hole1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- 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 16, 2020Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS A HOLE IN THE BALLOON OF A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY. IT WAS ALSO REPORTED THAT THE DEVICE WAS NOT RECEIVED DEFECTIVE, BUT WAS RATHER DAMAGED DURING USE DUE TO "OPERATOR ERROR". AS A RESULT, A SHILEY WAS ATTEMPTED TO BE USED TO "REPLACE THE DEFECTIVE PART" BUT WAS FOUND TO NOT BE COMPATIBLE. ULTIMATELY, A SECOND KIT WAS OPENED AND A NEW BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DEVICE DID MAKE PATIENT CONTACT AND NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10541196 ↗InjuryJan 20, 2019Device Slipped; Device Slipped
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Code Available
MAUDE report 8263163 ↗MalfunctionMar 28, 2018Leak/Splash
IT WAS REPORTED THAT THE CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY HAD A LEAK IN THE BALLOON. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7378348 ↗
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- 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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