Direxion™ M001195240Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729839354), received between May 17, 2019 and Jun 11, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DEVICE COMPONENT DETACHMENT OCCURRED. A DIREXION CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE USING THE DEVICE, AND A DEVICE COMPONENT DETACHED. THE DEVICE COULD NOT BE USED AS INTENDED AND AN ALTERNATE DEVICE WAS REQUIRED TO CONTINUE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474182 ↗
• MalfunctionAug 19, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OUTSIDE OF THE NECK. A DIREXION MICROCATHETER WAS SELECTED FOR USE FOR ARTERIOVENOUS MALFORMATION. DURING PROCEDURE, IN ATTEMPT TO DEPLOY THE COIL, THE COIL COULD NOT BE ADVANCED AFTER REPEATED ATTEMPTS. UPON FURTHER EXAMINATION, IT WAS FOUND THAT THE MICROCATHETER WAS FRACTURED AND COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS LOCATED IN THE CONNECTION BETWEEN CATHETER AND TORQUER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841190 ↗
• MalfunctionAug 19, 2025Break; Fracture; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN A FEMORAL ARTERY EMBOLISM. DURING THE PROCEDURE, UPON ADJUSTING THE DIRECTION OF THE MICROCATHETER, THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT A FRACTURE OCCURRED IN THE MIDDLE OF THE MICROCATHETER. THE INNER CAVITY REMAINED INTACT, WITH ONLY THE NICKEL ROD WAS FRACTURED AND THE SHAPING MANDREL STILL IN PLACE INSIDE THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838934 ↗
• MalfunctionMay 2, 2025Break; Fracture; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRONT PART OF THE MICROCATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A NGMC/SINGLE/021/BERN/1RO/130 DIREXION MICROCATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FRONT PART OF THE MICRO CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT IT WAS THE NICKEL JACKET OF THE TIP THAT WAS FRACTURED WITH THE INNER LINER STILL INTACT. THE FRACTURE OCCURRED AT 0.5CM FROM THE HUB WHICH COULD NEVER ENTER THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951684 ↗
• MalfunctionApr 29, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LIVER. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN TRANSARTERIAL EMBOLIZATION. DURING THE PROCEDURE, THE PART OF THE METAL CATHETER BODY THAT CONNECTED TO THE END OF THE TWIST-CONTROL HEAD WAS FRACTURED. 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 21930530 ↗
• MalfunctionApr 21, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN A RENAL ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION. DURING THE PROCEDURE, UPON ADVANCING/RETRACTING AND TRYING TO ACCESS, THE CATHETER BROKE. THE DEVICE WAS SIMPLY REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873019 ↗
• MalfunctionDec 19, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER GASTROINTESTINAL. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. THE MIDDLE PART OF THE CATHETER WAS FRACTURED AND WAS PULLED OUT WITHOUT ANY INTERVENTION DURING REMOVAL. THE DEVICE WAS NOT ENTIRELY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20980914 ↗
• MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A DIREXION CATHETER WAS SELECTED FOR USE IN THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE FRACTURED. 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 20523134 ↗
• MalfunctionOct 10, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BREAK OCCURRED. A DIREXION MICROCATHETER WAS SELECTED FOR LOWER EXTREMITY ANGIOGRAM. THE DEVICE WAS USED THROUGH A 5F DIAGNOSTIC CATHETER. HOWEVER, IT WAS NOTED THE MICROCATHETER WAS BROKEN DURING THE PROCEDURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418924 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PRIMARY HEPATIC FOR TREATMENT OF LIVER CANCER. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE INSIDE THE PATIENT, THE JOINT OF THE DEVICE WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TAIL END PLASTIC AND METAL JOINT WAS PARTIALLY FRACTURED AT ABOUT 10CM UPWARD TOWARDS THE TIP END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041117 ↗
• MalfunctionApr 22, 2024Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT A CATHETER KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION CATHETER-INFUSION WAS SELECTED FOR A TRANSARTERIAL CHEMOEMBOLIZATION. DURING INSERTION, IT WAS NOTED THAT THE DEVICE WAS KINKED. THE DEVICE WAS REMOVED, AND PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A FRACTURE IN THE NITINOL SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153770 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A DIREXION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE BROKE WHILE TORQUING. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757551 ↗
• MalfunctionAug 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED APPROXIMATELY 90CM FROM THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY NORMALLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH ANOTHER DIREXION. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17493039 ↗
• MalfunctionAug 4, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CHEST. A DIREXION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS STUCK INSIDE THE CATHETER, AND COULD NOT ENTER. THE CATHETER AND THE COIL WERE REMOVED, AND IT WAS NOTED THAT THE CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIREXION. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459413 ↗
• MalfunctionJul 20, 2023Fracture

  MIDDLE-AGED FEMALE WITH ACUTE ONSET OF RECTAL BLEED. PROCEDURE: IMA (INFERIOR MESENTERIC ARTERY) ANGIOGRAM AND EMBOLIZATION OF DESCENDING COLON. THE MICRO CATHETER HUB BROKE/FRACTURED DURING THE CONTRAST INJECTION. MICRO-CATHETER REMOVED WITHOUT KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360508 ↗
• MalfunctionJun 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A DIREXION WAS SELECTED FOR USE. AN ARTERIOVENOUS MALFORMATIONS (AVMS) WERE ACCESSED VIA DIREXION AND FATHOM WIRE. AFTER A FEW COIL DEPLOYMENTS, THE PHYSICIAN ATTEMPTED TO MOVE ONTO THE NEXT AVM, WHILE DOING SO, HE SAID HE FELT A POSSIBLE KINK WITHIN THE DIAGNOSTIC CATHETER AND BROKE THE DIREXION CATHETER, WHICH WAS INSIDE THE TOUHY. THE DEVICE WAS REMOVED FROM THE BODY INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DIREXION. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126993 ↗
• MalfunctionJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TAIL END OF THE CATHETER WAS FALLING OFF. A DIREXION CATHETER WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE TAIL END OF THE MICROCATHETER WAS FALLING OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038913 ↗
• MalfunctionDec 8, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER TIP BROKE. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, THE DIREXION WAS ATTEMPTED TO BE TAKEN OUT OF THE HOUSING HUB. THE MANDREL ACCIDENTALLY WAS NOT REMOVED AND BECAUSE IT HAS AN ANGLED TIP, THE CATHETER TIP BROKE OFF AS IT WAS ATTEMPTED TO BE TAKEN OUT OF THE HUB. THE DEVICE WAS NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941064 ↗
• InjuryAug 25, 2022Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT A BREAK OCCURRED RESULTING IN ADDITIONAL INTERVENTION. A DIREXION CATHETER WAS SELECTED FOR USE TO TREAT AN ENDOLEAK IN THE LUMBAR ARTERY. DURING WITHDRAWAL, THE CATHETER WAS DIFFICULT TO REMOVE AND RIPPED. IT TOOK ONE AND A HALF HOURS TO RETRIEVE THE BROKEN PART OF THE CATHETER FROM THE PATIENT. THE PATIENT MAY COME BACK AND GET TREATED AGAIN. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293876 ↗
• MalfunctionAug 5, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. A DIREXION MICROCATHETER WAS SELECTED FOR USE ON THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178176 ↗
• MalfunctionMar 10, 2022Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18FEB2022. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDE WIRE WAS STUCK BY THE Y VALVE OF THE MICROCATHETER AND COULD ONLY BE DELIVERED IN PART OF IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT SHOWED DAMAGE IN THE FORM OF A FRACTURE LOCATED 26.5CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722714 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A DIREXION CATHETER INFUSION WAS SELECTED FOR USE. AT THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636125 ↗
• MalfunctionJul 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE OUTER SHAFT RUPTURED. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, A LOOP FORMED, AND THE OUTER SHAFT RUPTURED IN THE MIDDLE OF THE CATHETER, OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215048 ↗
• MalfunctionApr 22, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT HEPATIC ARTERY. A DIREXION MICROCATHETER WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE WAS USED IN TRACKING THROUGH ANATOMY AND CONTINUOUS SALINE FLUSH WAS MAINTAINED. HOWEVER, IT WAS NOTED THAT THE NITINOL HYPOTUBE BROKE IN THE CENTER OF THE CATHETER. THE DEVICE WAS REMOVE COMPLETELY WITH THE TRANSCEND GUIDEWIRE WITHIN IT AND 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 9987006 ↗
• MalfunctionMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02MAY2019. A DIREXION CATHETER WAS USED DURING THE PROCEDURE. THERE WAS NO REPORTED COMPLAINT WITH THE DEVICE AND NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS OK POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED SEPARATIONS ON THE SHAFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654175 ↗