Cook G06420Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002064201), received between Sep 19, 2016 and Dec 18, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 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 18, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT DURING THE DEEP VEIN THROMBOSIS (DVT) PROCEDURE, THE MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET BEGAN LEAKING AT THE HUB WHILE IT WAS PLACED IN THE ILIAC VEIN. IT WAS FURTHER NOTED THAT THERE WAS A HAIRLINE CRACK IN THE HUB. IT IS UNKNOWN IF/HOW THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175173 ↗
• InjurySep 19, 2016Leak/Splash; Leak/Splash

  THE CATHETER WAS PLACED IN THE PATIENT WITH NO COMPLICATIONS AND WAS WORKING FINE. THE PATIENT WAS TRANSPORTED TO THE ROOM AND IT WAS NOTED THAT THE DEVICE STARTED LEAKING AT THE HUB. UPON INSPECTION A CRACK WAS DETECTED IN THE SEAL OF THE HUB. THE PATIENT WAS BROUGHT BACK TO SURGERY AND THE DEVICE EXCHANGED. NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5960667 ↗