Cook G00174Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002001749), received between Jul 30, 2019 and Apr 5, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. 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.

• MalfunctionApr 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, TWO POLYETHYLENE ANGIOGRAPHIC CATHETERS SPLIT DURING A PULMONARY ANGIOGRAM INVOLVING THE RIGHT COMMON FEMORAL VEIN. THE DEVICES EACH SPLIT WHEN ADVANCING OVER A GUIDE WIRE. NEITHER DEVICE WAS ADVANCED FAR ENOUGH TO ENTER AN ANGIOGRAPHIC SHEATH ALREADY IN PLACE IN THE PATIENT. A NEW 100CM PIGTAIL CATHETER WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013316 ↗
• MalfunctionJul 30, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, A HAIR WAS FOUND INSIDE THE PACKAGE OF A POLYETHYLENE ANGIOGRAPHIC CATHETER. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8842695 ↗