COOK G47456Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002474564), received between May 21, 2020 and May 25, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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.

• InjuryMay 25, 2020Mechanical Problem; Malposition of Device; Physical Resistance/Sticking; Mechanical Problem; Malposition of Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED FROM MEDWATCH (B)(4) ON (B)(6)2020 : DURING DEPLOYMENT OF THE DEVICE, THE GRAFT FULLY DEPLOYED BUT THE TRIGGER WIRE RELEASE CAP WOULD NOT COME FREE. THE SHEATH HAD TO BE CUT WHICH RESULTED IN LARGE VOLUME BLOOD LOSS WHILE THE TRIGGER WIRES WERE MANUALLY REMOVED TO RELEASE THE GRAFT FROM THE DELIVERY SYSTEM. THE WIRE BECAME STUCK IN THE DEVICE AND WIRE ACCESS TO THE VESSEL WAS LOST. THE LEFT GROIN CUT DOWN WAS PERFORMED AND PROXIMAL AND DISTAL CONTROL WAS ACHIEVED.

  Patient problems: Failure of Implant; Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 10085009 ↗
• InjuryMay 21, 2020Difficult to Remove; Malposition of Device; Difficult to Remove; Malposition of Device

  AS REPORTED "THE GREEN TRIGGER WIRE MECHANISM WAS UNABLE TO BE REMOVED FROM THE DELIVERY SYSTEM FOLLOWING DEPLOYMENT. THIS PREVENTED THE PHYSICIAN FROM BEING ABLE TO REMOVE THE DELIVERY SYSTEM AND REQUIRED THE TEAM TO TAKE MANUAL ACTION TO ACCESS AND REMOVE THE TRIGGER WIRES IN ORDER TO REMOVE THE DELIVERY SYSTEM. THE PHYSICIAN NEEDED TO CUT THE GREY INNER CANNULA IN ORDER TO ACCESS AND MANUALLY REMOVE THE INDIVIDUAL TRIGGER WIRES. THIS INTERVENTION WAS EFFECTIVE BUT INDUCED BLOOD LOSS THROUGH THE DELIVERY SYSTEM. WHILE ATTEMPTING TO REMOVE THE GREEN TRIGGER WIRE FROM THE TX2 DELIVERY SYSTEM, THE GRAFT WAS INADVERTENTLY REPOSITIONED SEVERAL MILLIMETERS RESULTING IN AN INADEQUATE PROXIMAL LANDING. AS A RESULT, AN ADDITIONAL ZDEG STENT GRAFT WAS REQUIRED TO ACHIEVE THE INTENDED PROXIMAL LANDING POSITION. THE DEPLOYMENT SYSTEM WAS SECURED IN A BIO-HAZARD BAG AND IT CURRENTLY BEING HELD AT THE HOSPITAL FACILITY."

  Patient problems: No Code Available

  MAUDE report 10080239 ↗