Cook G58413Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002584136), received between Nov 8, 2023 and May 6, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K180846); they may or may not involve this specific model.

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.

• MalfunctionMay 6, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETER INCLUDED IN THE ARTERIAL PRESSURE MONITORING TRAY OCCLUDED DURING AN UNKNOWN PROCEDURE FOR A PATIENT OF UNKNOWN AGE AND GENDER. UPON INSERTION OF THE CATHETER INTO THE FEMORAL ARTERY, THE 2.5 FR BY 5 CM CATHETER WAS FOUND TO BE DEFECTIVE AND COULD NOT BE FLUSHED. HOWEVER, AFTER USING A NEW DEVICE FROM A DIFFERENT KIT OF THE SAME SIZE AND LENGTH, THE LINE FLUSHED WITHOUT ANY ISSUES. IT IS UNKNOWN IF IMAGING WAS USED FOR DEVICE PLACEMENT. THE DEVICE WAS RETURNED FOR EVALUATION ON 29APR2025. UPON PRELIMINARY DFA FINDINGS AND ANALYSIS, IT WAS FOUND THAT THE CATHETER WAS FULL OF BIOLOGICAL MATTER AND COULD NOT BE FLUSHED BY A SYRINGE FILLED WITH TAP WATER. THE DEVICE WAS PLACED IN AN ULTRASOUND BATH FOR 15 MINUTES AND SOME CONGEALED BIOLOGICAL MATTER WAS CLEARED. THE CATHETER WAS THEN ABLE TO BE FLUSHED SUCCESSFULLY. AS REPORTED, 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 21970033 ↗
• MalfunctionApr 25, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETER INCLUDED IN THE ARTERIAL PRESSURE MONITORING TRAY OCCLUDED DURING AN UNKNOWN PROCEDURE FOR A PATIENT OF UNKNOWN AGE AND GENDER. THE USER WAS NOT ABLE TO FLUSH THE CATHETER. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21911778 ↗
• MalfunctionDec 3, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE ARTERIAL PRESSURE MONITORING TRAY UNRAVELED. THE PROVIDER PULLED OUT THE WIRE GUIDE TO TEST PRIOR TO PATIENT CONTACT AND FOUND THAT IT WAS UNCOILED AND UNUSABLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835988 ↗
• MalfunctionNov 8, 2023Obstruction of Flow; Obstruction of Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094603 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180846. One submission often covers many models, so check the product and lot details in each record.

• Z-1778-2026 · Mar 5, 2026 · Open, Classified
  COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419