Cool Line® Intravascular Heat Exchange Catheter Kit Non Heparin Custom Luer CL-2295AERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111075183), received between Aug 21, 2017 and Aug 21, 2017 — classified as 1 malfunction.

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 18, 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.

• MalfunctionAug 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT TREATED FOR THERAPEUTIC HYPOTHERMIA, THE COOL LINE CATHETER CAME OUT WHEN THE PATIENT CHANGE HER BODY POSITION. THE CATHETER WAS PLACED IN THE INTERNAL JUGULAR VEIN FOR APPROXIMATELY 30 MINUTES DWELL TIME. ACCORDING TO THE CUSTOMER," ARTIC SUN" WAS USED TO CONTINUE THE TREATMENT. CUSTOMER ALSO REPORTED THAT THE CATHETER WAS TOO LONG DUE TO THE PATIENT BODY SIZE. THE CATHETER WAS ANCHORED TO THE PATIENT WITH A SUTURE TAB CLIP. NO PATIENT HARM OR CONSEQUENCE WAS REPORTED ON THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6808687 ↗