DirexionRecalls & reported problems across all models

We found 14 models of Direxion by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Sep 27, 2018 and Aug 28, 2026 — classified as 6 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Break” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Direxion problems

Direxion models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Direxion™ M001195240

  Catheter, continuous flush
  26 reports
• Direxion™ M001195300

  Catheter, continuous flush
  14 reports
• Direxion™ M001195250

  Catheter, continuous flush
  9 reports
• Direxion™ M001195210

  Catheter, continuous flush
  6 reports
• Direxion™ M001195340

  Catheter, continuous flush
  4 reports
• Direxion™ M001195200

  Catheter, continuous flush
  3 reports
• Direxion™ M001195270

  Catheter, continuous flush
  3 reports
• Direxion™ M001195280

  Catheter, continuous flush
  3 reports
• Direxion™ M001195320

  Catheter, continuous flush
  2 reports
• Direxion™ M001195220

  Catheter, continuous flush
  1 report
• Direxion™ M001195230

  Catheter, continuous flush
  1 report
• Direxion™ M001195310

  Catheter, continuous flush
  1 report
• Direxion™ M001195330

  Catheter, continuous flush
  1 report
• Direxion™ M001195350

  Catheter, continuous flush
  1 report

Recent Direxion adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 9, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A DIREXION MICROCATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE OUTER LAYER OF THE CATHETER SPLIT IN THE PATIENT. THE DEVICE WAS REMOVED, AND 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 24546042 ↗
• 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 ↗
• MalfunctionDec 16, 2025Fracture; Nonstandard Device; Fracture; Nonstandard Device

  IT WAS REPORTED THAT THE DEVICE FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). HOWEVER, DURING COIL ADVANCING, A FRACTURE OCCURRED AT THE CONNECTION POINT OF THE MICROCATHETER'S DISTAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE 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 THE ROTATION AT THE END FRACTURED. NO FRACTURED DEVICE WAS INSIDE THE PATIENT BECAUSE IT WAS COMPLETELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817174 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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