Blue Rhino G57717Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002577176), received between Oct 22, 2021 and Jan 20, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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-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.

• InjuryJan 20, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED A (B)(6) MALE PATIENT HAD AN 8.5 FR TAPER GUARD TRACHEOSTOMY TUBE FROM A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY PLACED WITH NO ISSUES. THE PATIENT HAD COVID-19 AND HAD BEEN ON A VENT FOR ABOUT 4 WEEKS. THE PATIENT IMMEDIATELY HAD AN AIR LEAK OF 50 ML, BUT THE LEAK WAS NOT AUDIBLE. THREE DAYS AFTER PLACEMENT, THE AIR LEAK WAS UP TO 200 ML AND AUDIBLE. THE PRESSURE IN THE CUFF MEASURED 30, AND NEITHER INFLATING UP TO 45 NOR CHANGING HEAD POSITION RESOLVED THE AIR LEAK. ON THE SAME DAY, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE IN WHICH THE TUBE WAS REMOVED AND REPLACED WITH A DIFFERENT 8 FRENCH CUFFED TRACHEOSTOMY TUBE. THIS WAS DONE AT BEDSIDE AND REQUIRED SEDATION AND PARALYSIS. UPON REMOVAL, THE BALLOON WAS INTACT. CARE FOR THE TUBE WAS DESCRIBED AS SUCTIONING AS NEEDED. ADDITIONALLY, THE TRACH WAS SUTURED IN LOOSELY WITH 2 SUTURES AND HELD IN PLACE WITH TRACH STRAPS. THE PHYSICIAN ALSO PROVIDED THE FOLLOWING COMMENT REGARDING THE ISSUE: "SOMETIMES REPLACING THE 8.5 FR WITH AN 8 FR STILL RESULTS IN SOME AIR LEAK THAT IS NOT NORMALLY SEEN WHEN JUST STARTING PATIENTS OFF WITH AN 8 FR." NO OTHER ADVERSE EFFECTS WERE REPORTED. THE ADDITIONAL

  Patient problems: Insufficient Information

  MAUDE report 13308882 ↗
• MalfunctionOct 22, 2021Material Rupture; Gas/Air Leak; Material Rupture; Gas/Air Leak

  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 12682552 ↗

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