Cook G04035Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002040359), received between Mar 9, 2018 and Jul 11, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Fracture; Unraveled Material; Fracture; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET WAS DIFFICULT TO REMOVE DURING A CENTRAL VENOUS CATHETER INSTALLATION PROCEDURE ON A 3-MONTH-OLD MALE PATIENT. CENTRAL VENOUS CATHETER INSTALLATION INTO THE RIGHT FEMORAL VEIN WAS SCHEDULED ON (B)(6) 2024 DUE TO POOR PERIPHERAL ACCESS, THE NEED FOR SEDATION AND ANTIBIOTIC TREATMENT. UNDER ASEPTIC AND ULTRASOUND-GUIDED TECHNIQUE, A DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER WAS INSERTED INTO THE TARGETED VESSEL. THE VEIN WAS CANALIZED, AND THE WIRE GUIDE WAS ADVANCED UNTIL A STOP WAS FELT. A DECISION WAS THEN MADE TO WITHDRAW THE WIRE. DIFFICULTY WAS EXPERIENCED DURING ATTEMPTED REMOVAL AND AN ENTRAPMENT BECAME EVIDENT. ONCE AGAIN, AN ATTEMPT WAS MADE TO REMOVE THE WIRE GUIDE. IT WAS THEN DISCOVERED THAT THE WIRE GUIDE HAD FRAYED, WITH ONLY A PORTION BEING REMOVED FROM THE PATIENT. UPON ULTRASOUND EVALUATION OF FEMORAL VESSELS AND EXTRALUMINAL SPACE BY A VASCULAR SURGEON, THE METAL GUIDE WAS FOUND TO BE UNRAVELED DISTALLY, WITH A KNOT IN THE TIP. THE GUIDE WAS THEN PULLED UNDER ULTRASOUND, BUT THE GUIDE WAS UNABLE TO BE MOVED. FINALLY, TOGETHER WITH A PEDIATRIC SURGEON, T

  Patient problems: Foreign Body In Patient

  MAUDE report 19724135 ↗
• MalfunctionMar 13, 2019Crack; Leak/Splash

  NOTED CVC CRACKED AT HUB, MEDICATIONS LEAKING. LINE WAS IN PLACE FOR 6 DAYS. REQUIRED REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8416033 ↗
• MalfunctionFeb 1, 2019Crack; Crack

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8296946 ↗
• InjuryMar 9, 2018Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  THE CUSTOMER REPORTED THAT, DURING THE USE OF THE LEFT INTERNAL JUGULAR VEIN DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET, THE WIRE GUIDE BECAME TRAPPED IN THE INTRODUCER NEEDLE, MAKING IT IMPOSSIBLE TO PASS OR WITHDRAW THE WIRE GUIDE. UPON ATTEMPTED REMOVAL, THE WIRE GUIDE FRAYS. THE CUSTOMER INDICATED THAT, AS A RESULT OF THE PRODUCT PROBLEM, THE PATIENT'S BLOOD VESSEL RUPTURED. THE CUSTOMER DID NOT REPORT WHAT WAS DONE TO CORRECT THE CONDITION, AND IT IS UNKNOWN IF ADDITIONAL PROCEDURES WERE REQUIRED. THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Perforation of Vessels

  MAUDE report 7327288 ↗