Direxion™ HI-FLO™ M001195470Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729839545), received between Feb 19, 2019 and Mar 29, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MICROCATHETER DETACHMENT OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLISATION (TACE) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER BECAME STUCK AND RESISTANCE FELT WHEN THE CATHETER WAS REMOVED. THE DEVICE WAS REMOVED TOGETHER WITH THE NON-BOSTON SCIENTIFIC (BSC) IMAGING CATHETER, AND IT WAS NOTED THAT IT GOT SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004655 ↗
• MalfunctionOct 18, 2022Fracture; Obstruction of Flow; Physical Resistance/Sticking; Fracture; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR A UTERINE FIBROID EMBOLIZATION PROCEDURE. WHILE INJECTING BEADBLOCK, THE CATHETER CLOGGED SEVERAL TIMES. INTERMITTENT FLUSHING WAS PERFORMED TO RESOLVE THE CLOGGING. DURING REMOVAL FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE OUTER SHAFT WAS BROKEN AND DETACHED FROM THE INNER SHAFT. THERE HAD NOT BEEN A LOT OF TORQUING OF THE CATHETER BY THE INTERVENTIONAL RADIOLOGIST. THERE WERE NO PATIENT COMPLICATIONS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624247 ↗
• MalfunctionJun 22, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SPLENIC ARTERY. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE OUTER SHAFT OF THE CATHETER BROKE AND SPLIT INTO TWO AT THE AREA AWAY FROM THE HUB. THE DEVICE WAS REMOVED PER USUAL AND NO DEVICE PIECE WERE LEFT INSIDE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10179796 ↗
• MalfunctionJun 19, 2020Break; Break

  IT WAS REPORTED THAT A CATHETER SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERIOR MESENTERIC ARTERY (SMA). A 130 DIREXION HI-FLO WAS SELECTED FOR USE IN EMBOLIZATION. AFTER DELIVERING THE WIRE TO THE SMA, THE DIREXION WAS APPLIED TO THE BLOOD VESSEL. THE DIREXION WENT OUT FROM THE TARGET VESSEL, SO, IT WAS ATTEMPTED TO ENGAGE AGAIN. WHEN TRYING TO CHANGE THE DIRECTION OF THE CATHETER TIP BY APPLYING TORQUE, DISCOMFORT WAS FELT. WHEN THE WIRE AND CATHETER WERE PULLED OUT, IT WAS NOTED THAT THE OUTER SIDE OF THE DIREXION CATHETER GOT SEPARATED/BROKEN OFF, BUT THE INNER LINER WAS STILL CONNECTED (NOT SEPARATED). THE DEVICES WERE ABLE TO REMOVE FROM THE PATIENT BY SIMPLY PULLING OUT AND NO FRAGMENT REMAINED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174552 ↗
• MalfunctionFeb 19, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER FELL APART. A DIREXION HI-FLO CATHETER WAS SELECTED USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS WITHDRAWN, IT WAS NOTED THAT THE CATHETER FELL APART. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350288 ↗