Cook G47308Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002473089), received between Mar 26, 2026 and Mar 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 2, 2026Open, Classified

   Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

   Z-1935-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionMar 26, 2026Crack

  IT WAS REPORTED THAT THE "WALL" OF AN AUROUS CENTIMETER SIZING CATHETER "CRACKED" BELOW THE HUB OF THE CATHETER DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE USER NOTED A "WEIRD RATING", WHEN THE PRESSURE MONITOR WAS TURNED ON. THE USER NOTED BODILY FLUID LEAKING, AND THE CRACK WAS IDENTIFIED. THE HUB WAS NOT WIPED WITH ANY CLEANING SOLUTION. A POWER INJECTOR WAS NOT USED; RATHER MANUAL HAND INJECTION WAS PERFORMED. THE PROCEDURE WAS COMPLETED BY USING A DIFFERENT UNSPECIFIED CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703520 ↗
• MalfunctionMar 26, 2026Crack

  IT WAS REPORTED THAT THE "WALL" OF AN AUROUS CENTIMETER SIZING CATHETER "CRACKED" BELOW THE HUB OF THE CATHETER DURING AN IVC FILTER PLACEMENT PROCEDURE. THE CATHETER MADE PATIENT CONTACT. THE HUB WAS NOT WIPED WITH ANY CLEANING SOLUTION. THE CATHETER WAS CONNECTED TO AN UNSPECIFIED TUBING OR SYRINGE. AN UNSPECIFIED POWER INJECTOR WAS USED AT 900 PSI. THE CATHETER WAS NOTED TO BE LEAKING DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703413 ↗