Ciaglia Blue Rhino G12523Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002125230), received between Mar 28, 2018 and Oct 20, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗
• 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 ↗