Ciaglia Blue RhinoRecalls & reported problems across all models
Cook Incorporated · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Ciaglia Blue Rhino model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 7 models of Ciaglia Blue Rhino by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2016 and Oct 20, 2020 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (3 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Ciaglia Blue Rhino recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1781-2026 · Root cause: Incorrect or no expiration date · names 2 of these models · Recall details · FDA record ↗
Most reported Ciaglia Blue Rhino problems
Device problems
- Fail-Safe Did Not Operate3
- Inflation Problem2
- Device Contamination with Chemical or Other Material1
- Folded1
- Kinked1
- Material Deformation1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient3
- Laceration(s)1
- Low Blood Pressure/ Hypotension1
- Low Oxygen Saturation1
- No Code Available1
- No Patient Involvement1
Ciaglia Blue Rhino models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ciaglia Blue Rhino G12115Tube tracheostomy and tube cuff1 recall2 reports
- Ciaglia Blue Rhino G32092Tube tracheostomy and tube cuff1 recall0 reports
- Ciaglia Blue Rhino G12565Tube tracheostomy and tube cuff3 reports
- Ciaglia Blue Rhino G12523Tube tracheostomy and tube cuff2 reports
- Ciaglia Blue Rhino G12403Tube tracheostomy and tube cuff1 report
- Ciaglia Blue Rhino G12513Tube tracheostomy and tube cuff1 report
- Ciaglia Blue Rhino G13166Tube tracheostomy and tube cuff1 report
Recent Ciaglia Blue Rhino adverse event reports
The 10 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 20, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA OF A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH SHILEY WAS FOUND TO BE DEFORMED FOLLOWING PLACEMENT. WHILE EXACT DETAILS REGARDING THE DEFORMITY ARE UNKNOWN, THE PATIENT BECAME UNSTABLE, EXPERIENCING HYPOTENSION AND LOW OXYGEN SATURATION LEVELS AS A RESULT OF THIS EVENT. THEREFORE, THE TRACHEOSTOMY TUBE WAS REMOVED AND THE PATIENT WAS GIVEN "VASOACTIVE SUPPORT". ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation; No Code Available
MAUDE report 10706591 ↗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 ↗MalfunctionSep 10, 2019Inflation Problem; Inflation Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8982896 ↗MalfunctionAug 27, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE LAST MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8937037 ↗MalfunctionAug 19, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE BLUE RHINO DILATOR OF THE CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET SLIPPED PAST THE SAFETY RIDGE OF THE WHITE GUIDING CATHETER DURING A PERCUTANEOUS DILATATIONAL TRACHEOSTOMY PROCEDURE. AFTER A SCALPEL WAS USED TO ENLARGE THE INSERTION SITE, THE PHYSICIAN THEN PLACED THE 14FR INTRODUCER DILATOR ALONG THE WIRE GUIDE. THE INTRODUCER DILATOR WAS USED AND THE BLUE RHINO DILATOR WAS PLACED ABOVE THE SAFETY RIDGE ON THE GUIDING CATHETER. AS THE BLUE RHINO WAS PUSHED FORWARD, IT PASSED OVER THE SAFETY RIDGE. THE PHYSICIAN REMOVED THE DEVICE AND OPENED ANOTHER CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, NO ADVERSE EFFECTS WERE EXPERIENCED BY THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8908213 ↗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 ↗MalfunctionSep 25, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY WAS MISSING A COMPONENT. DURING INVESTIGATION, AN UNUSED/SEALED DEVICE WAS RETURNED FOR EVALUATION. FOREIGN MATTER WAS FOUND WITHIN THE SEALED STERILE TRAY.
Patient problems: No Patient Involvement
MAUDE report 7906185 ↗MalfunctionMar 28, 2018Inflation Problem
THE COMPLAINANT REPORTED THE FOLLOWING INFORMATION IN A VOLUNTARY MEDWATCH: DURING A PERCUTANEOUS TRACHEOSTOMY, A COOK CIAGLIA BLUE RHINO PERCUTANEOUS SIZE 8 TRACHEOSTOMY TUBE WAS INSERTED INTO THE PATIENT'S TRACHEA. THE VENTILATOR WAS CONNECTED TO THE TRACHEOSTOMY TUBE. HOWEVER THERE WAS DIFFICULTY VENTILATING THE PATIENT. IT WAS NOTED THAT THE BALLOON WAS NOT STAYING INFLATED. THEREFORE THE BRONCHOSCOPE WAS REINSERTED. THE GUIDEWIRE UNIT WAS REINSERTED THROUGH THE TRACHEOSTOMY TUBE. THE TRACHEOSTOMY TUBE WAS REMOVED AND A NEW TRACHEOSTOMY TUBE (SHILEY SIZE 8 CUFFED TRACHEOSTOMY TUBE) WAS INSERTED. THE BALLOON WAS INSUFFLATED AND IT REMAINED INSUFFLATED. THE VENTILATOR WAS CONNECTED AT THAT TIME AND PATIENT WAS SUCCESSFULLY VENTILATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7376780 ↗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 ↗InjuryMar 9, 2016Kinked; Kinked
DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE, THERE WAS A KINK IN THE WIRE. THE USER DID NOT NOTICE THIS UNTIL DILATOR WAS OVER THE WIRE. THE PART OF THE WIRE THAT WAS KINKED GOT CAUGHT IN THE PATIENT'S STOMA CAUSING SOME LACERATION AND EXTRA BLEEDING. THE USER FINISHED THE PROCEDURE SUCCESSFULLY WITH THIS DEVICE BY REPOSITIONING THE WIRE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS OTHER THAN MINOR BLEEDING DUE TO THIS OCCURRENCE.
Patient problems: Laceration(s)
MAUDE report 5488798 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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