Ciaglia Blue Rhino G2 G55650Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002556508), received between Aug 31, 2017 and Aug 31, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
Patient problems
- Respiratory Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, FOLLOWING A TRACHEOSTOMY PROCEDURE WITH A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE, A PIECE OF THE INNER CANNULA DETACHED. THIS RESULTED IN RESPIRATORY INSUFFICIENCY IN THE PATIENT. THE INNER CANNULA HAD TO BE CHANGED OUT. THE PRODUCT IS AVAILABLE FOR RETURN.
Patient problems: Respiratory Failure
MAUDE report 6835823 ↗
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- 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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