Melker G29432Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002294325), received between Sep 15, 2016 and Mar 28, 2018 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

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.

• MalfunctionMar 28, 2018Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE TIP OF THE DILATOR FROM THE MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET WAS FOUND TO BE BROKEN WHEN THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED ON THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7379463 ↗
• MalfunctionMar 28, 2018Partial Blockage; Failure to Advance

  IT WAS REPORTED THAT WHILE THE MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET WAS BEING SET UP PRIOR TO PATIENT CONTACT, THE TIP OF THE DILATOR WAS FOUND TO BE BLOCKED, SO THE WIRE GUIDE COULD NOT ADVANCE THROUGH THE DILATOR. THE SET WAS NOT USED, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7379037 ↗
• MalfunctionMar 27, 2018Difficult to Insert; Kinked

  IT WAS REPORTED THAT WHILE THE MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET WAS BEING USED, THE PLASTIC PART OF THE CATHETER INTRODUCER NEEDLE KINKED, AND THE WIRE GUIDE COULD NOT GET THROUGH IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BRONCHOSCOPE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374733 ↗
• DeathSep 15, 2016Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A (B)(6) MALE DIED DURING A CRICOTHYROIDOTOMY BEING PERFORMED IN THE INTER-CRICOTHYROID MEMBRANE. AFTER INTRODUCTION OF THE GUIDE WIRE, IT WAS IMPOSSIBLE TO SLIDE THE INTRODUCER MANDRIN (CANNULA MANDRIN) BEYOND THE FIRST FEW CENTIMETERS OF THE GUIDE. IT WAS IMPOSSIBLE TO INSERT SIMULTANEOUSLY THE CANNULA AND INTRODUCER OVER THE WIRE GUIDE BEYOND THE FIRST 4-5 CM. RESISTANCE WAS FELT DURING SEVERAL ATTEMPTS. ALSO, THE RECEIVING GUIDE SEEMED TO BE BLOCKED. AFTER SLIDING A METAL GUIDE (INTRODUCED BY ITS RIGID END) INTO THE MANDRIN BY THE OTHER END DURING TESTING, A JUMPING SENSATION OCCURRED. THUS, RELEASING THE CHANNEL AND ALLOWING THE GUIDE TO SLIDE IN COMPLETELY. THERE WAS A DELAY IN TREATMENT AND OXYGENATION IN THE CRITICAL STAGE. A SURGICAL TRACHEOSTOMY WAS PERFORMED BY AN ENT. THE PATIENT DIED.

  Patient problems: Anoxia; Death

  MAUDE report 5952156 ↗