Direxion™ HI-FLO™ M001195410Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729839484), received between Nov 26, 2018 and May 7, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT MICROCATHETER WAS FRACTURED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A HEPATIC ARTERIAL INFUSION CHEMOTHERAPY. THE CATHETER WAS SUCCESSFULLY PLACED, AND PATIENT WAS INJECTED WITH CHEMOTHERAPY DRUGS. DURING NURSE'S WARD ROUND, THE PATIENT COMPLAINED THAT THERE WAS FLUID FLOWING OUT OF THE CATHETER ON THE RIGHT SIDE, AND IT WAS IMMEDIATELY CHECKED AND FOUND THAT THE MICROCATHETER WAS KINKED, 2ML OF BRIGHT RED BLOOD COULD BE SEEN FLOWING OUT THROUGH THE MICROCATHETER. A STERILE GAUZE WAS PRESSED AT THE PATIENT'S BLOODING END AND CLOSED THE INFUSION END. UPON CHECKING THE SPOT, IT WAS FOUND OUT THAT THE MICROCATHETER HAD CRACKS IN MANY PLACES AND COULD NOT BE USED ANYMORE. THE PHYSICIAN REMOVED THE MICROCATHETER AND ADJUSTED THE INFUSION OF CHEMOTHERAPY DRUGS THROUGH THE HEPATIC ARTERIAL CATHETER. THE PATIENT'S VITAL SIGNS WERE STABLE UNDER CONTINUOUS INFUSION ON THE SPOT AND THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS. THE DEVICE WAS DISPOSED AT THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19264465 ↗
• MalfunctionOct 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR LEFT GASTRIC ARTERY EMBOLIZATION COMBINED WITH HEPATIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED INSIDE THE PATIENT'S BODY. THE DEVICE WAS SLOWLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927059 ↗
• MalfunctionSep 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE 20% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LIVER. A NGMC/SINGLE/027/STRAIGHT/1RO/130 DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE FRACTURED ABOUT 37CM FROM THE HUB INSIDE THE BODY. THE DEVICE WAS REMOVED WITHOUT ANY ADDITIONAL INTERVENTION DONE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17811040 ↗
• MalfunctionDec 15, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE CATHETER SPLIT IN HALF. A DIREXION HI-FLO INFUSION CATHETER WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. THE CATHETER WAS INTRODUCED INTO THE PATIENT. HOWEVER, IT WAS NOTED THAT THE CATHETER APPEARED DAMAGED. IT WAS REMOVED, AND UPON INSPECTION, IT WAS FOUND KINKED AND SPLIT IN HALF. A NEW DIREXION HI-FLO WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15993157 ↗
• MalfunctionSep 10, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP BROKE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON CALCIFIED VESSEL. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE MIDDLE OF THE PROCEDURE, IT WAS NOTED THAT THE TIP STRETCHED AND WAS STRIPPED. UPON REMOVAL, THE DEVICE LOOKED BROKEN OR KINKED. IT WAS NOTED BY THE PHYSICIAN THAT THIS SAME EVENT HAD OCCURRED IN A PREVIOUS PROCEDURE WITH THE SAME DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452369 ↗
• MalfunctionSep 9, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED INFERIOR MESENTERIC ARTERY. A STRAIGHT/130 DIREXION HI-FLO CATHETER-FUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO A 5 FRENCH NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER BUT COULD NOT BE INSERTED FURTHER FROM THE MIDDLE AND IT GOT STUCK. THE DEVICE WAS REMOVED FROM THE ANGIOGRAPHIC CATHETER BY PULLING IT HARD AS THERE WERE SEVERE RESISTANCE ENCOUNTERED. A KINK WAS NOTED WHEN THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447250 ↗
• MalfunctionJul 16, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER WAS FLUFFING. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A DIREXION HI-FLO WAS SELECTED FOR USE. AFTER REMOVAL FROM THE BODY, A "FLUFFING" WAS SEEN OUTSIDE THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DISTAL PART OF THE CATHETER SHAFT LIFTED. THE ISSUE WAS VISIBLE AS IT OCCURRED OUTSIDE OF THE CATHETER SHAFT. ALSO, THERE WAS NO DIFFICULTY ENCOUNTERED UPON REMOVAL AS THE DEVICE WAS REMOVED IN THE USUAL WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180280 ↗
• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION HI-FLO CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12019121 ↗
• MalfunctionNov 26, 2018Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-NOV-2018. IT WAS REPORTED THAT THE CATHETER WAS KINKED. A 130 DIREXION HI-FLO WAS SELECTED FOR USE. DURING PREPARATION, WHILE REMOVING DEVICE FROM PACKAGING, IT WAS NOTED THAT THE CATHETER WAS KINKED RIGHT AFTER IT WAS REMOVED FROM HOOP. THE CATHETER WAS NEVER USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT FRACTURE 77CM FROM THE HUB. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SHAFT WAS VISUALLY EXAMINED. THE DEVICE SHOWED NO KINKS. THE DEVICE SHOWED DAMAGE IN THE FORM OF A FRACTURE LOCATED AT 77CM FROM THE HUB. THE DEVICE WAS NOT COMPLETELY SEPARATED THE INNER LINER WAS STILL ATTACHED. PER THE CUSTOMERS COMPLAINT SUMMARY, THE SHAFT WAS FRACTURED DURING REMOVAL FROM THE SHIPPING CARRIER TUBE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8103400 ↗