Cook G02067Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002020672), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 injury.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2022Break

  ON (B)(6) 2022 THE PATIENT HAD SEVERAL LINES PLACED, INCLUDING TWO ARTERIAL LINES IN HER BILATERAL GROINS. ON (B)(6) 2022 AT 0815 THE PATIENT'S RN NOTED THAT THE LEFT FEMORAL ARTERIAL LINE WAS BLEEDING. AS THE DRESSING WAS CHANGED THE RN DISCOVERED THAT THE CATHETER OF THE ARTERIAL LINE HAD BROKEN OFF AND A PORTION REMAINED IN THE PATIENT'S LEG. PHYSICIANS USED ULTRASOUND TO IDENTIFY THAT A 13CM PIECE OF THE BROKEN CATHETER WAS IN THE PATIENT'S GROIN. THE PATIENT WAS TAKEN EMERGENTLY TO THE OR (OPERATING ROOM) FOR SURGICAL REMOVAL OF THE BROKEN CATHETER. THE REMOVAL WAS COMPLETED WITHOUT SURGICAL COMPLICATIONS AND THE PATIENT HAS BEEN CLEARED FROM A SURGERY STANDPOINT. FDA SAFETY REPORT ID #(B)(4).

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 15916605 ↗