Cook G02089Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002020894), received between May 28, 2020 and Jun 29, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryJun 29, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT A COOK FEMORAL ARTERY PRESSURE MONITORING SET BROKE AT THE HUB, AND THE DISTAL ASPECT OF THE LINE REMAINED IN THE PATIENT'S FEMORAL ARTERY. A (B)(6) OLD FEMALE PATIENT, CONFIRMED TO BE COVID-19 POSITIVE, HAD A FEMORAL ARTERY PRESSURE MONITORING SET IMPLANTED FOR ARTERIAL BLOOD GAS (ABG) AND PRESSURE MONITORING. THE PHYSICIAN PLACED AND WAS SUTURING THE LINE TO ANCHOR IT TO THE SKIN WHEN THE CATHETER BROKE AT THE HUB AND COMPLETELY SEPARATED INTO TWO PIECES, WITH THE DISTAL ASPECT OF THE LINE REMAINING IN THE PATIENT'S FEMORAL ARTERY. THE PATIENT WAS NOT STABLE ENOUGH TO TRANSFER TO THE OPERATING ROOM TO EXPLANT THE CATHETER, SO A PLAN WAS MADE TO REMOVE THE DEVICE WHEN THE PATIENT STABILIZED OR IF LIMB ENDANGERMENT OCCURRED. THE PATIENT ULTIMATELY PASSED AWAY WITH THE CATHETER STILL INSIDE THEM. AT THIS TIME CAUSE OF DEATH IS UNKNOWN, HOWEVER IT IS NOT SUSPECTED TO BE CAUSED OR CONTRIBUTED TO BY THE DEVICE. NO AUTOPSY WAS PERFORMED. PER THE USER FACILITY, NO ADDITIONAL INFORMATION REGARDING THIS EVENT IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10207360 ↗
• MalfunctionMay 28, 2020Break

  THE FEMORAL ARTERIAL LINE WAS PLACED. THE PHYSICIAN WAS SUTURING THE LINE TO ANCHOR IT TO THE SKIN WHEN THE CATHETER BROKE AT THE HUB AND THE DISTAL ASPECT OF THE LINE REMAINED IN THE FEMORAL ARTERY, NO LONGER ATTACHED TO THE HUB. IT REMAINED IN THE BODY. VASCULAR SURGERY WAS CONSULTED. THE PATIENT WAS NOT STABLE TO TRANSFER TO THE OPERATING ROOM FOR REMOVAL. PLAN WAS TO REMOVE WHEN THE PATIENT STABILIZED OR IF LIMB ENDANGERMENT OCCURRED DEVICE ULTIMATELY REMAINED AS FOREIGN BODY IN PT. NO AUTOPSY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10095896 ↗