Direxion™ HI-FLO™ M001195420Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729839491), received between Aug 21, 2018 and Oct 21, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A SINGLE/027/STRAIGHT/1RO/155 DIREXION HI-FLO WAS SELECTED FOR LIVER CANCER TREATMENT. DURING THE PROCEDURE, IT WAS FOUND THAT THE MICROCATHETER WAS FRACTURED. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS ABOUT 5 TO 10CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495026 ↗
• MalfunctionJul 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT NICKEL SHAFT FRACTURE OCCURRED. A 027/STRAIGHT/1RO/155 DIREXION HI-FLO CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS IMPLANTED BUT COULDN'T BE ADVANCED AND WAS DISCOVERED TO BE BROKEN AROUND 0.2CM FROM THE HUB. THE DEVICE WAS REMOVED, AND 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 19799203 ↗
• MalfunctionJun 24, 2022Break

  EARLY 50¿S FEMALE WITH HISTORY OF UTERINE BLEEDING. PROCEDURE: BILIARY UTERINE ARTERY EMBOLISM AND PERCUTANEOUS SUPERIOR HYPOGASTRIC NERVE BLOCK. UPON INJECTING THE SURGIFOAM, 3 CATHETERS (1 AFTER THE OTHER) BROKE NEAR THE HUB. A FOURTH ONE USED WITHOUT DIFFICULTY. NO KNOWN HARM TO THE PATIENT, MINOR DELAY IN PROCEDURE. PLEASE NOTE THAT 3 DEVICES, CONSECUTIVELY BROKE IN THE SAME AREA- 2 DIFFERENT LOT NUMBERS. MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, DIREXION HI-FLO FATHOM-16 SYSTEM (PER SITE REPORTER). (B)(6). MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, DIREXION HI-FLO FATHOM-16 SYSTEM (PER SITE REPORTER). (B)(6). MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, DIREXION HI-FLO (PER SITE REPORTER). (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799309 ↗
• MalfunctionApr 21, 2022Break; Break

  IT WAS REPORTED NITINOL COATING CAME OFF. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE UTERUS AREA. A 155CM DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE NITINOL COATING CAME OFF AT ABOUT 20CM FROM PROXIMAL YELLOW HUB. SUBSEQUENTLY, THE PHYSICIAN LOST ALL TRACKING BUT WAS ABLE TO COMPLETE THE PROCEDURE WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14168701 ↗
• MalfunctionAug 7, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27JUL2020. IT WAS REPORTED THAT DEVICE GOT STUCK. A SINGLE/027/STRAIGHT/1RO/155 DIREXION HI-FLO CATHETER-INFUSION WAS SELECTED FOR A UTERINE FIBROID EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE DIREXION'S MICROCATHETER WAS STUCK INSIDE A NON-BSC URINARY CATHETER. BOTH CATHETERS WERE PULLED OUT. NO COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A COMPLETE SEPARATION IN THE OUTER SHAFT LOCATED 65.1CM FROM THE STRAIN RELIEF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379160 ↗
• MalfunctionApr 10, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PORTION OF THE DEVICE DETACHED. THE DIREXION HI-FLO CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE WHILE USING A 4F NON-BSC CATHETER THE DIREXION HI-FLO CATHETER GOT STUCK. DURING REMOVAL ATTEMPTS THE DIREXION HI-FLO CATHETER BROKE APART. THE DETACHED PORTION REMAINED WITHIN THE 4F CATHETER. THE 4F CATHETER WAS REMOVED AND REWIRED TO CONTINUE THE PROCEDURE. NO PATIENT CONSEQUENCES NOR COMPLICATION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8499925 ↗
• MalfunctionAug 21, 2018Break; Break

  IT WAS REPORTED THAT THE CATHETER BECAME FRACTURED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS NOT RESPONDING TO THE TORQUE AND WAS THEN REMOVED FROM THE PATIENT'S BODY. HOWEVER, IT WAS NOTED THAT THE PROXIMAL SHAFT OF THE CATHETER WAS FRACTURED AND HAD A SHREDDED APPEARANCE UPON REMOVAL. THE ENTIRE CATHETER WAS REMOVED SUCCESSFULLY AND NOTHING WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RETURNED PRODUCT CONSISTED OF A DIREXION MICRO-CATHETER. THE SHAFT WAS MICROSCOPICALLY INSPECTED. THE DEVICE SHOWED DAMAGE IN THE FORM OF A FRACTURED SHAFT IN 1 LOCATION AT 31.8CM FROM THE HUB. THE DEVICE WAS NOT COMPLETELY SEPARATED AS THE INNER LINER WAS STILL INTACT. 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 7802885 ↗