Cook G04135Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002041356), received between Apr 19, 2017 and Mar 24, 2021 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Crack” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564029 ↗
• MalfunctionNov 19, 2020Crack; Crack

  IT WAS REPORTED THAT THE BLUE HUB OF A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER WAS FOUND CRACKED. DURING INSERTION OF THE DEVICE IN THE PATIENT'S LEFT INTERNAL JUGULAR VEIN ON (B)(6) 2020, THE BLUE LUMEN CRACKED AS THE 3-WAY STOPCOCK WAS TWISTED AND LOCKED. THEREFORE, THE BLUE LUMEN WAS NOT USED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE DEVICE HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10869911 ↗
• InjuryOct 1, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 29SEP2020, IT WAS REPORTED THAT THE DEVICE'S INDICATION FOR PLACEMENT WAS FOR ADMINISTRATION OF INOTROPES. URGENT MEDICATION COULD NOT BE INFUSED AS PLANNED. A 24-HOUR INFUSION PUMP WAS ATTACHED TO THE DEVICE TO PREVENT BACKFLOW. THE WHITE LUMEN WAS STILL ABLE TO BE USED DESPITE THE CRACKED HUB ON THE BLUE LUMEN OF THE DEVICE. THE DEVICE WAS SECURED TO THE PATIENT USING "PLASTER."

  Patient problems: No Code Available

  MAUDE report 10614491 ↗
• MalfunctionAug 13, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405219 ↗
• InjuryJun 15, 2020Crack; Crack

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

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

  MAUDE report 10152996 ↗
• MalfunctionFeb 13, 2019Crack; Crack

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT.

  Patient problems: No Code Available

  MAUDE report 8336249 ↗
• MalfunctionApr 19, 2017Unraveled Material; Unraveled Material

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING INSERTION OF A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) FOR AN UNSPECIFIED INDICATION. THE GUIDE WAS INSERTED INTO THE PATIENT'S VEIN AND THE VESSEL WAS DILATED. THE CATHETER WAS PASSED OVER THE WIRE BUT WOULD NOT ADVANCE MORE THAN 3 CM. ULTRASOUND SCAN APPEARED TO SHOW THE WIRE IN THE VESSEL AND A 2ND ATTEMPT WAS MADE TO ADVANCE THE CATHETER WHICH ALSO FAILED. THE WIRE WAS REMOVED FROM THE VEIN AND APPEARED TO BE AT A 90 DEGREE ANGLE TO ITS LENGTH AND "THE INNER PART OF THE WIRE WAS EXPOSED." NO FURTHER INFORMATION WAS PROVIDED AS TO WHETHER OR NOT THE PROCEDURE WAS COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6504850 ↗