Cook Access Plus G07404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002074040), received between Dec 7, 2016 and Apr 4, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionApr 4, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL CUSTOMER REPORTED THAT THE HUB OF THE COOK ACCESS PLUS LUER-LOCK HIGH-VOLUME INFUSION INTRODUCER SET SEPARATED WHILE CONDUCTING IN-HOUSE TESTING OF THE DEVICE FOLLOWING A PREVIOUSLY REPORTED HUB SEPARATION. THE FORCES APPLIED AND TESTING PARAMETERS UTILIZED BY THE END USER WERE NOT PROVIDED. THE DEVICE WAS NOT INTENDED FOR PATIENT USE AT THE TIME OF TESTING, ACCORDINGLY, THERE IS NO PATIENT INVOLVEMENT. THE DESTRUCTIVELY TESTED DEVICE AND UNUSED SAMPLES WERE RETURNED FOR EVALUATION. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6456904 ↗
• InjuryDec 7, 2016Material Separation; Material Separation

  THE (B)(6) MALE PATIENT WAS AT HOSPITAL (#1) FOR ECMO (EXTRA CORPOREAL MEMBRANE OXYGENATION). ECMO IS A FORM OF EXTRACORPOREAL LIFE SUPPORT WHERE AN EXTERNAL ARTIFICIAL CIRCUIT CARRIES BLOOD FROM THE PATIENT TO A GAS EXCHANGE (OXYGENATOR) AND BECOMES ENRICHED WITH OXYGEN, AND CARBON DIOXIDE IS REMOVED. THE BLOOD THEN RE-ENTERS THE PATIENT CIRCULATION. ECMO CIRCUIT BLOOD IS OPTIMIZED TO PROVIDE ADEQUATE PATIENT SUPPORT IN THE ABSENCE OF NATIVE LUNG OR HEART FUNCTION¿. THIS IS A SPECIALIZED TREATMENT; WHICH CANNOT BE PERFORMED AT THE ABOVE MENTIONED HOSPITAL; THEREFORE, ECMO RETRIEVAL PERSONNEL FROM ANOTHER HOSPITAL (#2) CAME WITH EQUIPMENT AND THE REQUIRED PRODUCT TO PERFORM THIS PROCEDURE. THE USER INSERTED THE COOK BACKFLOW CANNULA IN THE RIGHT SUPERFICIAL FEMORAL ARTERY ON (B)(6) 2016. THE PATIENT WAS THEN TRANSFERRED TO THE ICU OF THE FACILITY (#2). APPROXIMATELY FOUR HOURS POST INSERTION, AN ICU DOCTOR WAS INSPECTING THE DRESSING/INSERTION SITE OF THE BACK FLOW CANNULA AND MOVED THE PATIENT'S LEG, WHEN THE HUB SEPARATED (CAME APART) FROM THE CATHETER, CAUSING AN ARTERIAL HEMORRHAGE. THE DOCTOR APPLIED PRESSURE, THE CATHETER WAS REWIRED AND A NEW DEVICE INSERTED. THE CATHETER RE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 6150877 ↗