Direxion™ HI-FLO™ Fathom™-16 System M001195740Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729839712), received between Oct 15, 2018 and May 12, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DIREXION PUSHED THROUGH BASE CATHETER, HOWEVER, BECAME STUCK WHEN TRYING TO RETRACT BACK INTO THE BASE CATHETER. THE DIREXION SEEMS TO BE GETTING CAUGHT WHERE THE NITINOL HYPOTUBE AND YELLOW DISTAL TIP ARE GLUED TOGETHER. DIREXION WILL PULL BACK INTO BASE CATHETER SMOOTHLY UNTIL THAT POINT MAKES CONTACT WITH THE DISTAL TIP OF THE BASE CATHETER. SEEMS AS IF THE JUNCTION BETWEEN HYPOTUBE AND DISTAL TIP IS TOO BIG TO PULL BACK INTO THE BASE CATHETER THEN GETS STUCK. ONCE STUCK, THE DIREXION CANNOT BE ADVANCED FORWARD EITHER. THE MICROCATHETER AND BASE CATHETER WERE REMOVED AS ONE BECAUSE THE MICROCATHETER WAS STUCK AND COULD NOT BE RETRACTED SEPARATELY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153679 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP END WAS BROKEN AND LEAKING LIQUID. 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 24680509 ↗
• InjuryApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VESSEL SPASM REQUIRING INTERVENTION. PATIENT WAS UNDER LOCAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS HEPATIC ARTERY. A DIREXION HI-FLO FATHOM, 16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON DELIVERING THE DOSE, IT WAS NOTED THAT THE NITINOL HYPOTUBE BROKE IN HALF REVEALING THE YELLOW SHEATH. UPON REMOVING THE MICROCATHETER, VESSEL SPASM OCCURRED. AN INTERVENTION WAS PERFORMED WITH NO LUCK TO OPEN BACK UP THE VESSEL. THE PROCEDURE WAS CANCELLED.

  Patient problems: Vasoconstriction

  MAUDE report 21893692 ↗
• MalfunctionFeb 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A VESSEL OF THE LIVER FOR A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING INSERTION, THE DEVICE WAS FRACTURED. 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 21375473 ↗
• MalfunctionJan 2, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2024. IT WAS REPORTED THAT THE HUB DETACHED. THE PATIENT PRESENTED WITH BLEEDING FROM THE STOMACH AND HAD COME FROM THE INTENSIVE CARE UNIT (ICU). PROFUSE BLEEDING HAD BEEN OBSERVED WITHIN THE PRIOR 12 HOURS. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE TO PLACE COILS IN THE LEFT GASTRIC ARTERY. AFTER TWO UNSUCCESSFUL ATTEMPTS TO INSERT COILS THROUGH THE DIREXION HI-FLO CATHETER HUB, THE HUB DETACHED. NO MASSIVE BLEEDING OCCURRED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A BROKEN GUIDEWIRE IN THE DISTAL TIP OF THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058546 ↗
• MalfunctionOct 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR LIVER CANCER TREATMENT. HOWEVER, UPON REMOVAL, IT WAS NOTED THAT THE OUTER LAYER OF THE CATHETER, WHICH WAS DISTAL TO THE STRAIN RELIEF, HAD SEPARATED. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392241 ↗
• MalfunctionAug 14, 2024Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE OUTER SHAFT BROKE. A DIREXION HI-FLO CATHETER WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. THE OUTER SHAFT OF THE CATHETER BROKE WHILE INSIDE THE PATIENT DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND EXCHANGED FOR A NEW DEVICE, SAME MODEL. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983624 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MICROCATHETER FRACTURED. AN 0.027IN BERN 130CM DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. THE PATIENT WAS BEING TREATED FOR LIVER CANCER. THE TARGET VESSEL WAS MILDLY TORTUOUS. DURING USE OF THE DIREXION MICROCATHETER TOGETHER WITH THE FATHOM GUIDEWIRE, THE DIREXION BROKE COMPLETELY AT APPROXIMATELY 20CM FROM THE HUB. ALL PARTS WERE ABLE TO BE PULLED FROM THE PATIENT, AND THE DIREXION WAS REPLACED WITH A RENEGADE MICROCATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551938 ↗
• MalfunctionJan 27, 2023Break; Defective Device; Difficult to Advance; Break; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, ADVANCEMENT OF COILS WAS DIFFICULT DUE TO MICROCATHETER STRETCHING TOWARDS MICROCATHETER TIP. IT WAS NOTED THAT THE CATHETER FRACTURED DURING ATTEMPTED ADVANCEMENT AND WITHDRAWAL, WITHIN THE BASE CATHETER, WITH JUST MILD TO MODERATE FORCE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16259087 ↗
• MalfunctionSep 30, 2022Entrapment of Device; Stretched; Entrapment of Device; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-SEP-2022. IT WAS REPORTED THAT THE CATHETER GOT STUCK AND STRETCHED. A 130CM DIREXION HI-FLO CATHETER-INFUSION WAS SELECTED FOR USE. HOWEVER, THE DEVICE APPEARED TO GET STUCK INSIDE THE BASE OF THE CATHETER AND STRETCHED. IT TOOK SOME TIME TO GET THE CATHETER POSITIONED INTO THE ORIGINAL LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513547 ↗
• MalfunctionSep 13, 2022Entrapment of Device; Stretched; Entrapment of Device; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19AUG2022. IT WAS REPORTED THAT THE DEVICE GOT STUCK INSIDE THE BASE CATHETER AND WAS STRETCHED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE GOT STUCK INSIDE THE BASE CATHETER AND EVENTUALLY GOT STRETCHED. IT TOOK TIME FOR THE DEVICE TO RETURN TO ITS INITIAL POSITION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED 2 SHAFT FRACTURES LOCATED 53.5CM AND 68CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412091 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 130CM DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER HAD A BREAK ALONG THE SHAFT WHICH CAUSED IT TO BE UNUSABLE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS DOING FINE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15193273 ↗
• MalfunctionMar 23, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. A DIREXION HI-FLO FATHOM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DIREXION WAS KINKED AND BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862247 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT THE OUTER SHEATH SEPARATED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ABDOMINAL ARTERY. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE INTRODUCTION, THE CATHETER WAS PULLED BACK TO REPOSITION, HOWEVER, THE OUTER SHEATH SEPARATED. THE DEVICE WAS PULLED BACK FROM THE SHEATH AND WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054432 ↗
• MalfunctionMay 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE YELLOW TIP OF CATHETER WAS DETACHED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING WITHDRAWAL, IT WAS NOTICED THAT THE YELLOW TIP OF THE DIREXION WAS FOUND ON THE END OF THE GUIDE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856674 ↗
• 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 10265617 ↗
• MalfunctionMar 17, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE IN HALF. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER CAME APART AND BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9841732 ↗
• MalfunctionOct 24, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. A 130 DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE IN THE LIVER. THE TARGET LESION HAD MORE THAN NORMAL TORTUOSITY AND SOME FRICTION WAS FELT DURING ADVANCEMENT OF THE DIREXION. DURING THE PROCEDURE INSIDE THE PATIENT, THE DIREXION BECAME STUCK IN A THE CATHETER AND THE SHAFT BROKE. THE MICROCATHETER WAS THEN PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 130 DIREXION HI-FLO FATHOM-16 SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9233670 ↗
• MalfunctionAug 8, 2019Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER BROKE IN HALF. A 130 DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS INSERTED INTO THE PATIENT'S NOSE TO TREAT EPISTAXIS. HOWEVER, THE COIL WOULD NOT ADVANCE AND IT WAS NOTED THAT THE MICROCATHETER BROKE INTO HALF. THE MICROCATHETER WAS THEN PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875286 ↗
• MalfunctionOct 15, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DISLODGEMENT OCCURRED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE CATHETER DISLODGED WHEN THE MANDREL WAS TAKEN OUT; CATHETER WAS THEN DISPOSED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965760 ↗