Turbo-Flo HD G35083Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002350830), received between Jun 13, 2017 and May 3, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE VENOUS LINE OF A TURBO-FLO HD HEMODIALYSIS CATHETER DID NOT CLOSE PROPERLY, WHICH RESULTED IN SOME DROPS OF BLOOD LOSS DESPITE IT BEING CLAMPED. DURING THE INITIAL INSERTION OF THE CATHETER, BEFORE CORRECT PLACEMENT WAS CONFIRMED, THE 2 LUMENS WERE CLAMPED OFF LEAVING ONLY THE CONNECTOR FREE. AT THIS TIME, THE CATHETER WAS OBSERVED TO BE LEAKING BLOOD AND NOT FUNCTIONING AS INTENDED. THE CATHETER REMAINED IN PLACE AND ITS REMOVAL DATE IS UNKNOWN. ADDITIONAL INFORMATION REGARDING THE EVENT AND CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 7484700 ↗
• InjuryMar 19, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE INTERNATIONAL CUSTOMER REPORTED THAT, UPON STARTING THE PATIENT'S DIALYSIS THERAPY IN WHICH A COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET WAS USED IN THE FEMORAL VEIN, SMALL BUBBLES WERE SEEN IN THE TUBING OF THE DEVICE. THE LUER LOCK WAS CHECKED, AND EVERYTHING APPEARED TO BE NORMAL. HOWEVER, SMALL BUBBLES WERE STILL OBSERVED ALONG THE ARTERIAL STRETCH. THE CUSTOMER THEN NOTICED THAT THE CONNECTION OF THE ARTERIAL STRETCH IS SLIGHTLY BROKEN, AND THAT A BLOOD LEAK WAS STAINING THE GAUZE THAT WAS UNDERNEATH IT. THE CATHETER ULTIMATELY HAD TO BE CHANGED OUT. THE PRODUCT IS UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7348927 ↗
• InjuryDec 7, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE VENOUS LINE OF THE TURBO-FLO HD HEMODIALYSIS CATHETER DID NOT CLOSE PROPERLY, WHICH RESULTED IN SOME DROPS OF BLOOD LOSS EVEN THOUGH THE LINE WAS CLAMPED. DURING THE INITIAL INSERTION OF THE CATHETER, BEFORE CORRECT PLACEMENT WAS CONFIRMED, THE 2 LUMENS WERE CLAMPED OFF, LEAVING ONLY THE CONNECTOR FREE DURING THAT STAGE OF THE PROCEDURE. HOWEVER, IT WAS AT THIS TIME THAT THE VENOUS LINE OF THE CATHETER LEAKED BLOOD. FROM THAT POINT ON, IT WAS OBSERVED THAT THE CLAMP DID NOT WORK WELL. THE CATHETER REMAINED IN PLACE. THE DEVICE HAS SINCE BEEN REMOVED AND IS REPORTED TO BE AVAILABLE FOR EVALUATION, HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION RECEIVED WHICH PROVIDED CLARIFICATION OF PATIENT OUTCOME. "THERE WAS NO ADVERSE EVENT FOR PATIENT. ONLY SOME DROPS OF BLOOD ESCAPE FROM CATHETER. NOTHING IMPORTANT, BUT IT SHOULD NOT LEAK WHEN CLAMPING. NO TRANSFUSION NEEDED, NOTHING INJURY FOR PATIENT."

  Patient problems: Blood Loss

  MAUDE report 7097197 ↗
• InjuryJun 13, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT THE COOK TURBO-FLO HD HEMODIALYSIS CATHETER WAS IN USE FOR TREATMENT. CUSTOMER STATES "DESPITE THE FORCEPS BEING CLOSED THE BLOOD KEPT FLOWING." THE CUSTOMER REPORTS THAT ANOTHER CATHETER WAS NEEDED. NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6636177 ↗