Cook G01203Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002012035), received between Apr 28, 2016 and Jan 20, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11202892 ↗
• MalfunctionJan 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11202878 ↗
• MalfunctionDec 27, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 THREE-WAY PLASTIC ROTATING ADAPTER STOPCOCKS WERE OPENED AND TWO WERE UNABLE TO BE USED DUE TO LEAKING. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6205060 ↗
• MalfunctionDec 13, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE THREE-WAY STOPCOCK LEAKED WHEN CONNECTED TO THE SHUTTLE SHEATH WITH A Y-ADAPTER. THE DEVICE WAS REPLACED WITH A NEW ONE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6170755 ↗
• MalfunctionNov 22, 2016Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHEN CYTOSTATICA IS GIVEN TO THE PATIENT. WHEN THEY FIRST FLUSH THE DEVICE WITH SALINE, THERE IS NO LEAKAGE, HOWEVER, WHEN CYTO IS GIVEN TO THE PATIENT, THE DEVICE STARTS TO LEAK. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. AS CC FORM: THEY USED ANOTHER DEVICE FROM ANOTHER SUPPLIER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6121603 ↗
• MalfunctionSep 13, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A DEVICE LEAKED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED BY OPENING ADDITIONAL STOPCOCKS UNTIL ONE WORKED. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5945563 ↗
• MalfunctionSep 13, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A DEVICE LEAKED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED BY OPENING ADDITIONAL STOPCOCKS UNTIL ONE WORKED. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5945546 ↗
• MalfunctionApr 28, 2016Leak/Splash; Leak/Splash

  DURING THE PROCESS OF GIVING CYTO TO THE PATIENT, IT WAS NOTED THAT THE PRODUCT WAS LEAKING. AIR IS COMING THROUGH THE ADAPTER WHEN EXTRACTION OF FLUID IS ATTEMPTED; THEREFORE, THE EXTRACTION IS IMPOSSIBLE. LEAKING HAS ALSO OCCURRED WHEN FLUID HAS BEEN INJECTED THROUGH THE ADAPTER, CAUSING THE FLUID TO END UP ON BLANKET OR ON THE PHYSICIAN /NURSE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5615276 ↗