Blue Rhino G57696Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002576964), received between Mar 4, 2022 and Mar 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 reports).

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-1427-2023 · 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 17, 2022Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE BLUE RHINO DILATOR INCLUDED IN THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WAS UNABLE TO BE ADVANCED DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE ON A MALE PATIENT. AS THE PHYSICIAN ADVANCED THE BLUE RHINO DILATOR, IT WAS "UNABLE TO PASS" WHILE CREATING THE STOMA. IT WAS NOTED THAT THE DISTAL END OF THE DILATOR WAS BENT, MAKING DILATION IMPOSSIBLE. THE TRACHEOTOMY WAS THEN COMPLETED WITH A TRACHEOSTOMY KIT FROM ANOTHER MANUFACTURER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801909 ↗
• MalfunctionMar 4, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE DILATOR OF THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET, "GIVES WAY WHEN DILATING" DURING PERCUTANEOUS TRACHEOSTOMY PROCEDURES. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13668009 ↗

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-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-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-1428-2023 · Apr 7, 2023 · Open, Classified
  Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-