Cook G07546Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002075467), received between Mar 28, 2018 and Dec 8, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS DISCOVERED WITHIN THE SEALED PACKAGING OF A MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET PRIOR TO OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15944002 ↗
• MalfunctionMar 28, 2018Break

  IT WAS REPORTED THAT WHEN THE USER PICKED UP THE SYRINGE FROM THE MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET AFTER OPENING THE PACKAGE, THEY FOUND THE PLUNGER OF THE PROXIMAL END WAS BROKEN. THEY REPLACED IT WITH ANOTHER ONE FROM THEIR STOCK, AND THE DEVICE DID NOT MAKE PATIENT CONTACT. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7378796 ↗