MelkerRecalls & reported problems across all models

We found 6 models of Melker by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Sep 15, 2016 and Jan 5, 2026 — classified as 2 deaths, 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Melker recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 5, 2026Open, Classified

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

   Z-1785-2026 · Root cause: Incorrect or no expiration date · names 2 of these models · Recall details · FDA record ↗

Most reported Melker problems

Melker models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Melker G32193

  Tube tracheostomy and tube cuff
  1 recall2 reports
• Melker G47665

  Tube tracheostomy and tube cuff
  1 recall0 reports
• Melker G29432

  Tube tracheostomy and tube cuff
  1 death4 reports
• Melker G06246

  Tube tracheostomy and tube cuff
  3 reports
• Melker G04652

  Tube tracheostomy and tube cuff
  1 report
• Melker G30488

  Tube tracheostomy and tube cuff
  1 death1 report

Recent Melker adverse event reports

The 11 most recent reports across all models, 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 18, 2020Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 19AUG2020. NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. THE PATIENT WAS HOSPITALIZED BUT IT IS UNKNOWN IF THEIR HOSPITALIZATION WAS PROLONGED. THIS OCCURRENCE CAUSED ADDITIONAL SWELLING TO THE PATIENT AND REQUIRED INTUBATION. THE COMPONENT WAS PLACED IN THE TRACHEA. THERE WAS DIFFICULTY EXPERIENCED INSERTING THIS DEVICE AS THE BALLOON WAS FAULTY. THE TUBE WAS IMMEDIATELY REMOVED WHEN PLACED AND THE PATIENT REQUIRED EMERGENT INTUBATION. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. IT IS UNKNOWN IF AN INITIAL INFLATION CHECK WAS PERFORMED PRIOR TO DEVICE PLACEMENT.

  Patient problems: No Code Available; Swelling

  MAUDE report 10421492 ↗
• MalfunctionJul 30, 2020Inflation Problem

  BALLOON IN CRICOTHYROTOMY KIT WOULD NOT INFLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10343585 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 27, 2018Dull, Blunt

  THE COMPLAINANT REPORTED THAT THE SCALPEL PROVIDED IN THE MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET WAS DULL AND UNUSABLE. THIS PRODUCT PROBLEM OCCURRED TWICE, BUT IT DID NOT RESULT IN ANY REPORTED ADVERSE EFFECTS TO THE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7374280 ↗
• DeathMar 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT OXYGEN COULD BE DELIVERED TO THE PATIENT THROUGH THE MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER, BUT IT COULD NOT BE REMOVED THROUGH THE DEVICE. THE APERTURE OF THE CATHETER WAS REPORTEDLY SO SMALL THAT VENTILATION COULD NOT BE ACHIEVED, ALTHOUGH OXYGENATION DID OCCUR BECAUSE THE AIR COULD BE FORCED IN. AUTO-PEEP (POSITIVE END EXPIRATORY PRESSURE) RESULTANTLY DEVELOPED. THE PATIENT WAS TAKEN BACK TO THE OR TO EXCHANGE THE DEVICE EMERGENTLY FOR A TRACH, BUT ULTIMATELY THE PATIENT EXPIRED. THE MANUFACTURER GLOBAL PRODUCT MANAGER HAS ATTEMPTED TO GAIN ADDITIONAL INFORMATION ON 16MAR2018 AND WAS REDIRECTED TO THE USER FACILITY RISK MANAGEMENT DEPARTMENT. THE MANUFACTURER GLOBAL PRODUCT MANAGER WAS ABLE TO SPEAK WITH THE NURSE PRESENT FOR THE PROCEDURE ON 19MAR2018, SHE DID NOT PROVIDE ADDITIONAL INFORMATION BUT HAS INDICATED SHE WOULD HAVE THE PHYSICIAN RETURN THE MANUFACTURER'S CALL. THE CUSTOMER HAS INDICATED THAT THEY ARE UNWILLING TO PROVIDE PATIENT-RELATED INFORMATION. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: Death; No Code Available

  MAUDE report 7362896 ↗
• 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 ↗
• 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 ↗

Other Cook Incorporated products

• Torcon NB79 models · 36 reports · 68 recalls
• Flexor134 models · 1,437 reports · 3 recalls
• Instinct5 models · 1,289 reports · 1 recall
• Saeed15 models · 863 reports
• Advance206 models · 816 reports
• Gunther Tulip5 models · 807 reports
• Hemospray2 models · 535 reports · 4 recalls
• NCircle10 models · 725 reports