Cook G02092Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002020924), received between Apr 13, 2017 and Jan 26, 2024 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2024Unable to Obtain Readings; Obstruction of Flow; Unable to Obtain Readings; Obstruction of Flow

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2024. THE DEVICE WAS SAID TO BE IN PLACE FOR ONE HOUR OR MORE PRIOR TO THE FAILURE. THE CATHETER WAS FLUSHED INTRAOPERATIVELY WITH SALINE SOLUTION WITHOUT HEPARIN BEFORE PUNCTURING THE ARTERY. HOWEVER, JUST FLUSHING THE CATHETER WAS NOT ENOUGH; A MANUAL FLUSH WITH 0.9% SALINE SOLUTION IN A SYRINGE WAS NECESSARY TO UNCLOG THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586702 ↗
• InjurySep 3, 2021Complete Blockage; Unable to Obtain Readings; Complete Blockage; Unable to Obtain Readings

  IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 06OCT2021 THAT THERE WAS RESISTANCE WHEN ADVANCING THE CATHETER OVER THE WIRE. IT WAS NOTED THAT THERE WAS BENDING BETWEEN THE CATHETER AND THE "FIXATION BUTTERFLY", CAUSING OBSTRUCTION "WITH VERY HIGH FREQUENCY", DESPITE THE USE OF PROPER INSERTION AND FIXATION TECHNIQUES. "SLIP" (AS INITIALLY REPORTED) REFERRED TO THE TIP OF THE CATHETER OPENING WHEN SLIDING THROUGH THE GUIDE AND ENCOUNTERING RESISTANCE IN THE SKIN. SELDINGER TECHNIQUE WAS USED TO INSERT THE DEVICE. THE CATHETER WAS REPLACED WITH ONE FROM ANOTHER MANUFACTURER. THERE WAS NO DIFFICULTY PLACING THE REPLACEMENT DEVICE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION/PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421085 ↗
• InjuryFeb 1, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT A RADIAL ARTERY PRESSURE MONITORING CATHETER WAS OBSTRUCTED, PREVENTING A BLOOD PRESSURE READING FROM BEING OBTAINED. A (B)(6) YEAR OLD FEMALE PATIENT IN POSTOPERATIVE SURGERY HAD A CATHETER PLACED IN THE RIGHT RADIAL ARTERY IN THE UPPER LIMB. THE DEVICE WAS SECURED TO THE PATIENT WITH A CATHETER BUTTERFLY. AN ARTERIAL PRESSURE MONITORING LINE WAS ATTACHED TO THE CATHETER. IMAGING WAS NOT USED TO AID IN THE PLACEMENT OF THE DEVICE. WHEN PERFORMING THE SANITIZATION AND REPOSITIONING OF THE LIMB, IT WAS VERIFIED THAT INVASIVE PRESSURE WAS NOT BEING READ. SEVERAL WASHING MANEUVERS WERE PERFORMED TO UNBLOCK THE DEVICE BUT WERE UNSUCCESSFUL. IT WAS REPORTED THAT THE DEVICE WAS REPLACED. UPON REMOVAL, NO DEFECT OF THE DEVICE WAS NOTED..

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11259575 ↗
• MalfunctionNov 4, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Patient Involvement

  MAUDE report 9273629 ↗
• MalfunctionSep 10, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Patient Involvement

  MAUDE report 8983352 ↗
• MalfunctionJul 8, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

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

  Patient problems: No Patient Involvement

  MAUDE report 8768422 ↗
• MalfunctionDec 21, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 8192293 ↗
• MalfunctionDec 18, 2018Break

  THE COMPLAINANT REPORTED THAT THE PACKAGE FOR THE SINGLE LUMEN DISTAL AORTIC PRESSURE MONITORING SET WAS NOTED TO BE BROKEN DURING INSPECTION. THIS PRODUCT PROBLEM WAS NOTED PRIOR TO PATIENT CONTACT, AND IT DID NOT RESULT IN ANY REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8176654 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A RADIAL ARTERY PRESSURE MONITORING CATHETER ON AN UNSPECIFIED DATE. THE PATIENT COMPLAINED OF UPPER LEFT LIMB PAIN AND EDEMA AND A "LOSS PAM." IT IS OPINED DUE TO A LANGUAGE BARRIER THAT THE "LOSS PAM" REFERS TO A LOSS OF PERIPHERAL ARTERIAL MONITORING. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED. IT IS OPINED THAT THE LOSS OF MONITORING RESULTED IN A NEED TO EXPLANT THE DEVICE AND PERFORM A REPLACEMENT. HE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6489570 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A RADIAL ARTERY PRESSURE MONITORING CATHETER ON (B)(6) 2017 VIA A LEFT RADIAL ARTERY PUNCTURE ROUTE. RADIAL ARTERY PRESSURE MONITORING THROUGH THE DEVICE WAS LOST ON (B)(6) 2017; ONE DAY FOLLOWING PLACEMENT OF THE DEVICE AND INITIATION OF MONITORING. IT IS OPINED THAT THE DEVICE WAS EXPLANTED AND A REPLACEMENT ARTERIAL MONITORING CATHETER WAS PLACED. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6489558 ↗