Cook G00040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002000407), received between Nov 5, 2019 and Feb 2, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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.

• MalfunctionFeb 2, 2021Fluid/Blood Leak; Leak/Splash; Material Split, Cut or Torn; Fluid/Blood Leak; Leak/Splash; Material Split, Cut or Torn

  AS REPORTED, DURING A PULMONARY ANGIOGRAM A MEDIUM PRESSURE CONNECTING TUBE BEGAN TO LEAK AFTER THE PRESSURE INJECTION CAUSED A HOLE IN THE SIDE OF THE DEVICE. THE MACHINE PRESSURE WAS SET AT 800 (NO UNITS PROVIDED). IT STATED THE PRESSURE DURING THE EVENT WAS 797. OMNIPAQUE WAS BEING INJECTED AT 30ML/S AND 20ML/S. THERE WAS NO CHANGE OR IMPACT ON THE PATIENT CARE OR OUTCOME. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT WAS REPORTED DUE TO THIS OCCURRENCE.

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

  MAUDE report 11267485 ↗
• MalfunctionNov 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED 10NOV2019. THE CUSTOMER REPORTED THAT THEIR INJECTOR WAS MALFUNCTIONING, AND THE ISSUE WAS NOT WITH THE ORIGINALLY REPORTED COOK DEVICE ASSOCIATED WITH THIS COMPLAINT. THE CUSTOMER HAS HAD THE UNKNOWN MANUFACTURER'S INJECTOR SERVICED AND THERE HAVE BEEN NO FURTHER PROBLEMS WITH THE TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280650 ↗
• MalfunctionNov 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280543 ↗
• MalfunctionNov 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED 10NOV2019. THE CUSTOMER REPORTED THAT THEIR INJECTOR WAS MALFUNCTIONING, AND THE ISSUE WAS NOT WITH THE ORIGINALLY REPORTED COOK DEVICE ASSOCIATED WITH THIS COMPLAINT. THE CUSTOMER HAS HAD THE UNKNOWN MANUFACTURER'S INJECTOR SERVICED AND THERE HAVE BEEN NO FURTHER PROBLEMS WITH THE TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279970 ↗