Blue Rhino G57716Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002577169), received between Jun 9, 2022 and Mar 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K193133); they may or may not involve this specific model.

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. Apr 7, 2023Class IOpen, Classified

   There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.

   Z-1428-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionMar 25, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE DILATOR INCLUDED IN THE BLUE RHINO G2- MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WAS DIFFICULT TO ADVANCE THROUGH THE TRACHEOSTOMY TUBE. THE PHYSICIAN SELECTED AN 8.5 FRENCH (FR) LOADING DILATOR TO MATCH THE 8.5 TRACHEOSTOMY TUBE; HOWEVER, THE DILATOR WAS UNABLE TO ADVANCE THROUGH THE TUBE. A NEW DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS AN USED DEVICE, AND IT WAS CONFIRMED THAT THE IMAGE WAS OF THE FIRST DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691534 ↗
• MalfunctionJun 9, 2022Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT A TRACHEOSTOMY PROCEDURE WHERE A COOK BLUE RHINO G1-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER WAS USED. THE PATIENT DID NOT HAVE ANY ANATOMICAL ANOMALIES THAT WOULD HAVE MADE THE PROCEDURE DIFFICULT TO PERFORM. BRONCHOSCOPE GUIDANCE WAS USED DURING PLACEMENT. THE WIRE GUIDE WAS INSERTED THROUGH THE NEEDLE. THERE WAS NO DIFFICULTY ADVANCING THE WIRE GUIDE INTO THE TRACHEA. THE WIRE GUIDE WAS NOT WITHDRAWN AT THE SAME TIME THE DILATOR AND CATHETER WERE REMOVED. THE GUIDE WIRE WAS REPORTED TO HAVE "LOOPED BACK ON ITSELF AND WAS KINKING INSIDE THE TRACHEA." THE PROCEDURE WAS COMPLETED, BUT THE USE OF A BRONCHOSCOPE WITH FORCEPS WAS REQUIRED TO REMOVE THE WIRE. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) EXAMINATION WAS REQUIRED TO RULE OUT ESOPHAGEAL INJURY AFTER THE REMOVAL OF THE GUIDE WIRE. THE EVENT DID NOT PROLONG THE PATIENT'S HOSPITALIZATION. NO OTHER ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14642308 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193133. One submission often covers many models, so check the product and lot details in each record.

• Z-1779-2026 · Mar 5, 2026 · Open, Classified
  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA
• Z-1780-2026 · Mar 5, 2026 · Open, Classified
  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-
• Z-1427-2023 · Apr 7, 2023 · Open, Classified
  Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FL