Blue Rhino G57685Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002576858), received between Sep 14, 2021 and Sep 9, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. Mar 5, 2026Class IIOpen, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1779-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF THE 14 FRENCH PUNCH DILATOR INCLUDED IN THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET SEPARATED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005640 ↗
• InjuryMar 24, 2025Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT TRACHEAL INJURY OCCURRED DURING USE OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET. A 61-YEAR-OLD MALE UNDERWENT A BEDSIDE BRONCHOSCOPY AND PERCUTANEOUS TRACHEOSTOMY PLACEMENT PROCEDURE. THE GUIDE WIRE WAS INSERTED FIRST, AND THEN THE BLUE RHINO DILATOR WAS USED TO FURTHER DILATE THE TRACHEOSTOMY SITE. A #8 CUFFED TRACHEOTOMY TUBE WAS INSERTED AND THEN WAS REMOVED TO CLARIFY THE PLACEMENT. THE BRONCHOSCOPY WAS ADVANCED THROUGH THE ENDOTRACHEAL TUBE (ETT), AND A TEAR IN THE POSTERIOR TRACHEAL WALL WAS VISUALIZED. VENTILATION WAS THEN RESUMED. DIAGNOSTIC STUDIES, INCLUDING A COMPUTED TOMOGRAPHY SCAN AND CHEST X-RAY, AND A THORACIC CONSULT WERE ORDERED. THE PATIENT WAS NOT A SURGICAL CANDIDATE DUE TO HIGH CO-MORBIDITIES AND REQUIRED A DOUBLE LUMEN ETT. PER PHYSICIAN NOTES, BILATERAL CHEST TUBES WERE INSERTED SECONDARY TO THE INCIDENT. THE INDICATION FOR THE RIGHT SIDED CHEST TUBE WAS A PNEUMOTHORAX RESULTING FROM THE INCIDENT. THE LEFT SIDED CHEST TUBE WAS INSERTED AS A PROPHYLACTIC MEASURE SECONDARY TO THE HIGH RISK OF PNEUMOTHORAX. IT IS UNKNOWN IF THE TRACHEAL WALL INJURY WAS CAUSED BY THE WIRE GUIDE OR THE BLUE RHINO DILATOR. THE CUSTOMER BE

  Patient problems: Pneumothorax; Upper Respiratory Tract Injury

  MAUDE report 21678694 ↗
• MalfunctionAug 4, 2023Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465631 ↗
• MalfunctionSep 14, 2021Material Deformation; Material Too Soft/Flexible; Material Deformation; Material Too Soft/Flexible

  IN ADDITIONAL INFORMATION RECEIVED ON 22SEP2021, IT WAS REPORTED THAT THIS WAS A COVID PATIENT THAT REQUIRED VENTILATION. IT WAS CONFIRMED THAT DIFFICULTY WAS EXPERIENCED DURING INITIAL PLACEMENT OF THE DEVICE INTO THE TRACHEA, "WHEN RAILROADING THE HORN OVER THE WIRE, THE TIP BUCKLED AND WAS NOT FIRM ENOUGH TO ENTER THE TRACHEA." THE TUBE WAS SUCCESSFULLY PLACED USING A SET FROM ANOTHER MANUFACTURER. THE PATIENT DID NOT HAVE ANATOMY THAT WOULD HAVE MADE PERCUTANEOUS TRACHEOSTOMY DIFFICULT TO PERFORM. IMAGING WAS NOT BEING USED AT THE TIME OF THE PROCEDURE. THE ACCESS SITE WAS PRE-DILATED WITH THE 14FR INTRODUCER DILATOR, AND THE HYDROPHILIC COATING OF THE BLUE RHINO WAS ACTIVATED. THE BLUE RHINO WAS ADVANCED WITH THE WHITE GUIDING CATHETER OVER THE WIRE. NO ADDITIONAL LUBRICANT WAS REQUIRED FOR ADVANCEMENT. IT WAS ALSO REPORTED THAT THE USER MAY HAVE NOT "DISSECTED DOWN ENOUGH", AS A "FIRMER" MODEL WOULD NOT REQUIRE THEM TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468196 ↗

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-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-
• 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