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Turbo-Flo HD G35082Recalls & reported problems

Cook Incorporated · Cook Turbo-Flo HD Hemodialysis Catheter Set Double Lumen Polyurethane · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002350823), received between May 17, 2018 and May 18, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.

Most reported problems

Device problems

  • Difficult to Remove1
  • Uncoiled1

Patient problems

  • Needle Stick/Puncture1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 18, 2018Uncoiled

    THE COMPLAINANT REPORTED THAT THE WIRE UNTANGLED DURING INSERTION OF THE COOK TURBO-FLO HD HEMODIALYSIS CATHETER INTO THE RIGHT INTRA JUGULAR VEIN. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7525836 ↗
  • MalfunctionMay 17, 2018Difficult to Remove

    THE COMPLAINANT REPORTED THAT THE COOK TURBO-FLO HD HEMODIALYSIS CATHETER WAS SUCCESSFULLY PLACED, BUT THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO REMOVE THE WIRE. THE PHYSICIAN HAD TO USE FORCE WHEN REMOVING THE WIRE WHICH RESULTED IN UNTANGLING OF THE WIRE. THE CATHETER WAS REMOVED AND ANOTHER PUNCTURE OF THE SUBCLAVIAN VEIN WAS REQUIRED TO INSERT A NEW VASCULAR CATHETER. NO SECTIONS OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY AS A RESULT OF THE PRODUCT PROBLEM, AND THERE WAS NO OTHER PATIENT IMPACT REPORTED.

    Patient problems: Needle Stick/Puncture

    MAUDE report 7523792 ↗

Other CATHETER, HEMODIALYSIS, NON-IMPLANTED devices

All CATHETER, HEMODIALYSIS, NON-IMPLANTED devices →

Sources and updates

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