Direxion™ HI-FLO™ M001195500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729839576), received between Dec 11, 2019 and May 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 0.027IN SWAN TIP 130CM DIREXION? HI-FLO? MICROCATHETER WAS SELECTED FOR USE IN THE LIVER DURING A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION PROCEDURE. OUTSIDE THE PATIENT, WHEN THE MICROCATHETER WAS UNPACKED AND REMOVED FROM THE PACKAGING, IT FELT STIFF AND COULD NOT BE ADVANCED INTO THE RADIOGRAPHY CATHETER. THE MICROCATHETER WAS FOUND TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162944 ↗
• MalfunctionMar 26, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS A LEAKAGE NOTED WHILE PRIMING THE LINE WITH WATER, AND THE CATHETER WAS ASSESSED TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706044 ↗
• MalfunctionAug 11, 2025Nonstandard Device; Detachment of Device or Device Component; Material Integrity Problem; Nonstandard Device; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE ENTIRE TIP WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778605 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER HEPATIC ARTERY EMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT OF THE CATHETER WAS BROKEN. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835290 ↗
• MalfunctionFeb 7, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14JAN2022. IT WAS REPORTED THAT RESISTANCE WAS FELT DURING ADVANCEMENT AND DEVICE KINKED WHEN REMOVED. A 130CM DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS ADVANCED OVER A WIRE, HOWEVER RESISTANCE WAS FELT WHILE ADVANCING THROUGH A NON-BSC 1.0 CATHETER AND THE DEVICE HAD A KINK WHEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURED SHAFT LOCATED AT 42CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475830 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT THE TIP WAS BROKEN. A DIREXION HI FLO INFUSION CATHETER AND NON-BSC GUIDEWIRE WIRE WERE SELECTED FOR USE IN A PROSTATE EMBOLIZATION PROCEDURE. AFTER THE DIREXION CATHETER HAD BEEN INSERTED INTO THE PATIENT, THE NON-BSC GUIDEWIRE WAS INSERTED INTO THE CATHETER. THE PHYSICIAN FELT SOMETHING UNUSUAL AND DECIDED TO REMOVE BOTH THE CATHETER AND GUIDEWIRE. THE PROXIMAL TIP OF THE CATHETER WAS DAMAGED. THE INNER LAYER APPEARED BROKEN. A NEW DEVICE, SAME MODEL, WAS SELECTED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS AND WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453213 ↗