Cook G01950Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002019508), received between Mar 9, 2023 and Mar 9, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• InjuryMar 9, 2023Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  PER ADDITIONAL INFORMATION RECEIVED, THE CATHETER BROKE OFF AT THE CONNECTION AND WAS IN THE PATIENT'S ARTERY. A VASCULAR SURGEON WAS CONSULTED AND WAS ABLE TO RETRIEVE THE CATHETER. THE PROCEDURE WAS PERFORMED AND COMPLETED AT BEDSIDE. THE INTENSIVIST HAD TO STAND AT THE BEDSIDE FOR APPROXIMATELY TWO HOURS TO MAKE SURE THE CATHETER DID NOT MIGRATE. NO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE NURSE NOTED THE CATHETER APPEARED UNDAMAGED IN THE PACKAGING AND AT TIME OF INSERTION. ALSO, THE PATIENT WAS NO LONGER IN THE ICU WAS NOTED AS A PRE-EXISTING CONDITION. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16516846 ↗