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Ciaglia Blue Rhino G12115Recalls & reported problems

Cook Incorporated · Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set · Class 2

All models of Ciaglia Blue Rhino (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002121157), received between Aug 19, 2019 and Aug 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (2 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

  1. Mar 5, 2026Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Device problems

  • Fail-Safe Did Not Operate2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • 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 ↗

Other Tube tracheostomy and tube cuff devices

All Tube tracheostomy and tube cuff devices →

Sources and updates

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