Direxion™ HI-FLO™ M001195450Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729839521), received between Oct 8, 2018 and Aug 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH # (B)(4) THAT A DEVICE BREAK OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR USE. PRIOR TO PROCEDURE, IT WAS NOTED THAT THE WIRE WITHIN THE MICROCATHETER WAS FOUND BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874301 ↗
• MalfunctionJul 28, 2025Break

  THE WIRE WITHIN MICROCATHETER WAS FOUND BROKEN DURING PREP OF THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED WITH NO REPORTED HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR MICROCATHETER, 2.8FR DISTAL OD X 155CM DIREXION HI-FLO TORQUEABLE MICROCATHETER, BERN TIP, 0.02 (PER SITE REPORTER). MFG [MANUFACTURER] NOTIFIED BY SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22622806 ↗
• MalfunctionJul 9, 2024

  MIDDLE-AGED FEMALE WITH HISTORY OF UTERINE FIBROIDS AND BLEEDING. PROCEDURE: BILATERAL UTERINE ARTERY EMBOLISM PROCEDURE. SUPERIOR HYPOGASTRIC NERVE BLOCK. 500-700U EMBOSPHERES BEING PUSHED, AND THE CATHETER SEPARATED FROM THE HUB. CATHETER EXCHANGED WITHOUT FURTHER PROBLEM. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, DIREXION HI-FLO (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700601 ↗
• MalfunctionApr 21, 2023Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A DIREXION HI-FLO CATHETER WAS SELECTED FOR USE. IT WAS NOTED THAT THE MIDDLE OF THE CATHETER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784835 ↗
• MalfunctionJul 8, 2022Break

  EARLY 30¿S FEMALE WITH HISTORY OF CHRONIC PELVIC PAIN AND PELVIC VARICES. PROCEDURE: LEFT RENAL AND OVARIAN VENOGRAM, EMBOLISM OF LEFT-OVARIAN VEIN AND PARA-UTERINE VEINS, PELVIC VENOGRAM SUPERIOR HYPOGASTRIC NERVE BLOCK. DURING THE PROCEDURE, THE YELLOW END OF THE CATHETER MALFUNCTIONED AND BROKE. BROKEN PIECE WAS OUTSIDE OF THE BODY- CATHETER REMOVED WITHOUT KNOWN HARM TO PATIENT. A NEW CATHETER USED WITHOUT INCIDENT. MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, DIREXION¿ HI-FLO¿ (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955833 ↗
• MalfunctionDec 18, 2020Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15DEC2020. IT WAS REPORTED THAT HUB BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS UTERINE ARTERY. A DIREXION HI-FLO WAS SELECTED FOR USE. THE DEVICE WAS HYDRATED PRIOR TO REMOVAL FROM THE HOOP. TOWARDS THE END OF THE EMBOLIZATION ADMINISTRATION, IT WAS NOTED THAT THE HUB BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT FRACTURES AT 81.5CM AND 82CM FROM THE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11038245 ↗
• MalfunctionJul 13, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS CRACKED/BROKEN. A 130CM DIREXION HI-FLO FATHOM-16 SYSTEM AND A 155CM DIREXION HI-FLO WERE NOTED TO BE CRACKED/BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10265627 ↗
• MalfunctionJan 21, 2020Material Twisted/Bent; Material Twisted/Bent

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07JAN2020. IT WAS REPORTED THAT CATHETER WAS BENT. THE TARGET LESION AREA WAS LOCATED IN THE PELVIC AREA. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER GOT BENT. THE DEVICE WAS PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE SHAFT WAS FRACTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610668 ↗
• MalfunctionAug 23, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. A DIREXION HI-FLO CATHETER WAS SELECTED FOR USE IN A UTERINE FIBROID EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS DIFFICULT TO REMOVE FROM THE PATIENT AND THE GUIDEWIRE USED ALSO BECAME BENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925470 ↗
• MalfunctionJul 8, 2019Break; Break

  IT WAS REPORTED THAT THE DISTAL TIP BROKE. A DIREXION HI-FLO INFUSION CATHETER WAS SELECTED FOR USE. DURING PREPARATION THE DISTAL TIP OF THE CATHETER BROKE, THE DEVICE WAS EXCHANGED WITH ANOTHER DIREXION HI-FLO INFUSION CATHETER, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8767697 ↗
• MalfunctionOct 8, 2018Material Deformation; Material Deformation

  REPORTABLE BASED ON ANALYSIS DONE ON 25SEP2018. IT WAS REPORTED THAT THE SHAFT KINK OCCURRED. A 027/155 DIREXION HI-FLO WAS SELECTED FOR USE TO TREAT A LESION LOCATED IN THE LIVER, VASCULAR ACCESS WAS GAINED VIA THE RIGHT GROIN AND IT WAS NOTED THAT THE MICROCATHETER KINKED DURING THE PROCEDURE. THE CATHETER WAS REMOVED AND AN ADDITIONAL DIREXION MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. DEVICE EVALUATED BY MFR: THE SHAFT WAS MICROSCOPICALLY EXAMINED. THE DEVICE SHOWED DAMAGE IN THE FORM OF A FRACTURED SHAFT IN 1 LOCATION. THE SHAFT WAS FRACTURED 62.5CM FROM THE HUB. 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 7945316 ↗