Direxion™ HI-FLO™ M001195440Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729839514), received between Jul 20, 2018 and Jul 22, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25JUN2025. IT WAS REPORTED THAT THE MICROCATHETER WAS BLOCKED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A RIGHT THORACIC TUMOR AND BRONCHIAL ARTERY CHEMOEMBOLIZATION PROCEDURE. DURING PROCEDURE, THE MICROCATHETER WAS BLOCKED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE NICKEL SHAFT WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568351 ↗
• MalfunctionAug 7, 2023

  ELDERLY FEMALE WITH HISTORY OF CAD (CORONARY ARTERY DISEASE), HTN (HYPERTENSION), DM (DIABETES MELLITUS) AND CIRRHOSIS OF THE LIVER. PROCEDURE: CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) OF ABDOMEN AND PELVIS WITH CONTRAST. WHILE INJECTING CONTRAST INTO THE PATIENT, THE HUB OF THE CATHETER BROKE OFF. THE CATHETER WAS FLUSHED PRIOR TO USE. 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 17469055 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. THE 75% TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LIVER. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS DETACHED. THE DEVICE WAS REMOVED FROM THE PATIENT NORMALLY WITHOUT FRAGMENTS LEFT INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743573 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LIVER. A NGMC/SINGLE/027/BERN/1RO/130 DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS DETACHED WHICH MIGHT BE CAUSED BY A PROBLEM IN THE COATING OF THE PRODUCT, AS PER PHYSICIAN'S OPINION. THE DEVICE WAS REMOVED NORMALLY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743402 ↗
• MalfunctionJul 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS DETACHED. THE TARGET LESION WAS LOCATED IN THE LIVER AREA. A DIREXION HI-FLO CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS DETACHED. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981195 ↗
• MalfunctionJul 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS DETACHED. THE TARGET LESION WAS LOCATED IN THE LIVER AREA. A 130CM DIREXION HI-FLO CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS DETACHED. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981173 ↗
• MalfunctionJul 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A DIREXION HI-FLO CATHETER WAS SELECTED FOR USE ON THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER HAD FALLEN OFF. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. 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 14940918 ↗
• MalfunctionJul 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS DETACHED. THE TARGET LESION WAS LOCATED IN THE LIVER VESSEL. A NGMC/SINGLE/027/BERN/1RO/130 DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER DETACHED. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14939002 ↗
• MalfunctionJul 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER'S TIP WAS COMPLETELY DETACHED. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FRAGMENT WAS LEFT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14938928 ↗
• MalfunctionJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A DIREXION HI-FLO CATHETER WAS SELECTED FOR USE ON THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER HAD FALLEN OFF. THE DEVICE WAS SIMPLY PULLED OUT AND THERE WAS NO DEVICE FRAGMENT LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859041 ↗
• MalfunctionJun 21, 2021Material Separation; Component Missing

  PATIENT WITH HISTORY OF BREAST CANCER AND LEVER METS (LIVER METASTASES?) WAS ADMITTED FOR A YTTRIUM-90 RADIOEMBOLIZATION MAPPING AND THERAPY. AFTER OPENING THE BOSTON SCIENTIFIC DIREXION¿ HI-FLO¿ TORQUABLE MICROCATHETER, IT WAS OBSERVED THAT THE SILVER COVERING WAS MISSING ON PART OF THE CATHETER, WITH A SEPARATION. THE FAULTY TORQUABLE MICROCATHETER WAS NOT USED ON THE PATIENT. A REPLACEMENT WAS USED WITHOUT A PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 12031481 ↗
• MalfunctionJan 14, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE CATHETER BECAME DETACHED. A DIREXION HI FLO INFUSION CATHETER WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLIZATION PROCEDURE IN THE LEFT HEPATIC ARTERY. AFTER VASCULAR ACCESS WAS GAINED, THE CATHETER WAS PLACED INTO POSITION AND THE GUIDEWIRE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO INJECT CONTRAST BUT WAS UNABLE. IT WAS THEN OBSERVED THAT THE CATHETER HAD DETACHED FROM THE HUB. THE CATHETER WAS ALSO KINKED WHICH OBSTRUCTED THE INNER LUMEN. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-BSC DEVICE. THE PATIENT EXPERIENCED INCREASED RADIATION. THE PROCEDURE WAS COMPLETED AND NO ADVERSE PATIENT EFFECTS OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9588167 ↗
• MalfunctionApr 23, 2019Break; Break

  IT WAS REPORTED THAT A SEPARATION OF THE SHAFT OCCURRED. A DIREXION HI-FLO CATHETER WAS SELECTED FOR A PATIENT PROCEDURE INVOLVING THE PATIENT'S LIVER. DURING THE PROCEDURE, INSIDE THE PATIENT, THE SHAFT OF THE CATHETER BECAME FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541312 ↗
• MalfunctionMar 19, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 027/BERN/1RO/130 DIREXION HI-FLO CATHETER WAS SELECTED FOR USE FOR AN "ICE" EMBOLIZATION PROCEDURE. DURING WITHDRAWAL, IT WAS NOTED THAT THE TOP LAYER OF THE DIREXION HAD BEEN RELEASED FROM THE MIDDLE PART OF THE MICRO-CATHETER. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432635 ↗
• MalfunctionJul 20, 2018Break; Crack; Detachment of Device or Device Component

  THE HUB OF THE MICRO-CATHETER CRACKED. IT BROKE OFF OUTSIDE THE PATIENT, AND THE PHYSICIAN USED ANOTHER MICRO-CATHETER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705897 ↗