Melker G06246Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002062467), received between Nov 9, 2016 and Jan 5, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER FROM A MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET KINKED. THE DEVICE WAS REQUIRED FOR AN EMERGENCY CRICOTHYROTOMY PROCEDURE PERFORMED OUTSIDE OF THE HOSPITAL. DURING THE PROCEDURE, A CRICOTHYROID MEMBRANE PUNCTURE WAS PERFORMED WITHOUT COMPLICATION. GAS ASPIRATION WAS CONFIRMED. THE WIRE GUIDE WAS INSERTED WITHOUT RESISTANCE, AND A WIDE INCISION WAS MADE AROUND THE WIRE. THE DILATOR WAS ADVANCED OVER THE WIRE WITHOUT DIFFICULTY AND REACHED THE GUARD WITHOUT EFFORT. THE DILATOR WAS THEN REMOVED. THE DILATOR AND CATHETER WERE ASSEMBLED TOGETHER AND WERE ADVANCED OVER THE WIRE. AT THIS TIME, THE CATHETER APPEARED "TOO FLEXIBLE" AND WAS "CRUSHED" AGAINST THE PATIENT'S SKIN AND THE DILATOR AND DID NOT ADVANCE. FINALLY, THE CATHETER WAS INSERTED WITH SOME EFFORT FROM TWISTING; HOWEVER, THE TWISTING MOVEMENT ORIENTED THE CATHETER TOWARDS THE "VAS" PREVENTING ANY VENTILATION. 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 23957434 ↗
• InjuryAug 20, 2018Break; Break

  A LETTER WAS RECEIVED ON (B)(6) 2018 FROM (B)(6) HOSPITAL (B)(6) INFORMING THE MANUFACTURER OF AN INCIDENT THAT OCCURRED ON (B)(6) 2018. IT WAS REPORTED A PATIENT UNDERWENT A CRICOTHYROTOMY PROCEDURE PERFORMED BY A DOCTOR FROM (B)(6) TEAM IN AN EMERGENCY VEHICLE. THE PATIENT WAS IN CARDIOPULMONARY ARREST DUE TO A QUINCKE EDEMA FOR 15-MINUTES PRIOR TO THE INITIATION OF PROCEDURE. THE PATIENT PASSED NOT BECAUSE OF A FAILED PROCEDURE BUT BECAUSE VITALS WERE COMPROMISED FROM CARDIOPULMONARY ARREST. A (B)(6) EMERGENCY CRICOTHYROTOMY CATHETER SET WAS THE . DEVICE UTILIZED IN THE CRICOTHYROTOMY. AS REPORTED, THE GUIDE FOR MOUNTING THE CANNULA BROKE WHEN REMOVING THE DILATOR. THE CRICOTHYROIDOTOMY WAS UNABLE TO BE PERFORMED RELATE TO EDEMA. WHEN THE EDEMA REGRESSED, THE PATIENT WAS INTUBATED BY ORAL TRACHEA ROUTE. ADDITIONAL INFORMATION HAS BEEN REQUESTED INCLUDING IF AN AUTOPSY REPORT IS AVAILABLE, ADDITIONAL SEQUENCE OF EVENT DETAILS, THE LENGTH OF TIME BEFORE ORAL TRACHEAL INTUBATION WAS ACHIEVED, AND MEDICATIONS AND OTHER DEVICES USED DURING THIS EVENT. HOWEVER, THE REPORTER STATED THAT THE PATIENT DEATH WAS NOT LINKED WITH USE OF THE DEVICE. THEREFORE, THEY WOULD NOT COMMUNICATE ANY M

  Patient problems: Death; Patient Problem/Medical Problem

  MAUDE report 7799908 ↗
• MalfunctionNov 9, 2016Break; Break

  IT WAS REPORTED WHILE PERFORMING A PROCEDURE THE BLADE OF THE CATHETER SET BROKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AS OF THE DATE OF THIS REPORT NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6089618 ↗