Direxion™ M001195300Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729839415), received between May 19, 2021 and Aug 28, 2026 — classified as 1 injury, 13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508438 ↗
• MalfunctionMay 4, 2026Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A DIREXION WAS SELECTED FOR USE IN THE LIVER FOR TRANSCATHETER HEPATIC ARTERIAL CHEMOEMBOLIZATION. DURING THE PROCEDURE, WHEN THE GUIDEWIRE CROSSED THE TIP OF THE CATHETER, A DISTINCT RESISTANCE WAS FELT, AND IT COULD NOT BE PULLED BACK. 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 25071247 ↗
• MalfunctionMar 12, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. A DIREXION MICROCATHETER WAS SELECTED FOR AN EMBOLIZATION DURING THE MANAGEMENT OF ACTIVE BLEEDING. DURING THE MICROCATHETERIZATION OF THE ARTERY WITH THE DIREXION MICROCATHETER, THE MICROCATHETER FRAME BROKE. THE RADIOLOGIST CUT THE MICROCATHETER TO REMOVE IF AND USED A NEW MICROCATHETER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586597 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FRACTURE OCCURRED. A DIREXION WAS SELECTED FOR USE IN A PROSTATE ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE DIREXION FRACTURED AT THE DISTAL END. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323255 ↗
• MalfunctionJun 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A DIREXION CATHETER INFUSION WAS SELECTED FOR USE. WHILE INSPECTING AND SHAPING THE TIP OF THE DEVICE, IT FRACTURED AND COULD NO LONGER BE USED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152700 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A SINGLE/021/SWAN/1RO/130 DIREXION CATHETER-INFUSION BROKE DURING POWER INJECTION. A DIFFERENT DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559016 ↗
• MalfunctionMar 7, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE TIP RUPTURED. THIS DIREXION CATHETER WAS SELECTED FOR USE IN A PROSTATE EMBOLIZATION PROCEDURE WITH A NON-BOSTON SCIENTIFIC LIQUID EMBOLIZATION AGENT. DURING THE PROCEDURE, THE TIP OF THE MICROCATHETER REMAINED EMBEDDED IN THE EMBOLIC AGENT, WITH THE OUTER FRAME BREAKING OFF ON ATTEMPTED REMOVAL. ONLY THE INTERNAL PORTION REMAINED, STRETCHING UNDER TRACTION UNTIL IT BROKE OFF. THE MICROCATHETER RUPTURED IN THE 5F CATHETER AND THE FRAGMENT INSIDE THE PATIENT WAS RETRIEVED FROM OUTSIDE THE INTRODUCER. FURTHER TRACTION ENABLED THE ENTIRE FRAGMENT TO BE REMOVED COMPLETELY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861193 ↗
• MalfunctionOct 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN THE BRONCHOPULMONARY ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED ABOUT 60CM FROM THE HUB. 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 17927423 ↗
• MalfunctionMay 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DIREXION CATHETER BROKE DURING USE. A DIREXION CATHETER WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE DIRECTION CATHETER BROKE APART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950462 ↗
• MalfunctionJan 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE OUTER LAYER OF THE DEVICE WAS FRACTURED APPROXIMATELY 30CM FROM THE HUB. THE PROCEDURE WAS COMPETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163950 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER WAS FOUND TO BE FRACTURED WHEN SUPERSELECTING THE THIRD BLOOD VESSEL. 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 15374776 ↗
• InjuryFeb 22, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A DIREXION WAS SELECTED FOR MICROCATHETERIZATION OF AN ENDOLEAK OF THE ABDOMINAL AORTA VIA THE ARC OF RIOLAN. AFTER EMBOLIZATION, MAJOR RESISTANCE OCCURRED WITHDRAWING THE DEVICE CAUSING PEELING OF THE EXTERNAL FRAME OF THE MICROCATHETER. AN INTEGRATED PORTION OF THE MICROCATHETER WAS FOUND TO AIDE IN REMOVAL WITHOUT LEAVING A FRAGMENT IN THE SMA OR THE ARC OF RIOLAN. A SPASM WAS NOTICED AT THE BEGINNING OF THE ARC OF RIOLAN, WITH NO PRIOR FUNCTIONAL REPERCUSSIONS.

  Patient problems: Cramp(s) /Muscle Spasm(s); Vasoconstriction

  MAUDE report 13580853 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT AN OUTER GRAY SHAFT BROKE OFF EXPOSING THE INNER PURPLE. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN ADVANCING THE DEVICE OVER THE NON BOSTON SCIENTIFIC GUIDEWIRES, THE PHYSICIAN FELT SOME "GAVE-WAY". THE DEVICE WAS THEN REMOVED AND NOTED THAT THE OUTER GRAY SHAFT BROKE OFF EXPOSING THE INNER PURPLE LAYER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192083 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED LIVER. A DIREXION CATHETER INFUSION WAS SELECTED FOR USE. DURING PROCEDURE, THE PHYSICIAN WAS TRYING TO NAVIGATE A VERY TIGHT HAIRPIN TURN. AFTER SEVERAL TRIES OF TRYING TO PUSH THE DIREXION MICROCATHETER AROUND THIS TURN, HE REMOVED THE DEVICE FROM THE PATIENT. DURING REMOVAL, IT WAS NOTICED THAT THE MICROCATHETER WAS BROKEN HALFWAY UP. THE DEVICE WAS REMOVED FROM THE PATIENT BY PULLING THE DEVICE INTACT. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC PRODUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852240 ↗