Direxion Transend-14 SystemRecalls & reported problems across all models

We found 3 models of Direxion Transend-14 System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2020 and Sep 22, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 Transend-14 System problems

Direxion Transend-14 System models

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

• Direxion™ Transend™-14 System M001195840

  Catheter, continuous flush
  16 reports
• Direxion™ Transend™-14 System M001195810

  Catheter, continuous flush
  4 reports
• Direxion™ Transend™-14 System M001195850

  Catheter, continuous flush
  4 reports

Recent Direxion Transend-14 System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50854109 ↗
• MalfunctionMay 13, 2026Fracture

  IT WAS REPORTED THAT THE OUTER LAYER FELL OFF. A DIREXION MICROCATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE OUTER LAYER OF THE MICROCATHETER FELL OFF. NO PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT'S BODY. 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 25164872 ↗
• MalfunctionApr 24, 2026Degraded

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. PRIOR TO PROCEDURE, IT WAS NOTED THAT THE COATING AT THE TAIL END OF THE DEVICE WAS FOUND TO BE PEELED OFF. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983172 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MALIGNANT NEOPLASM OF RECTUM. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, A FRACTURE WAS FOUND 10 CM AFTER ENTERING THE VESSEL. THE DEVICE WAS REMOVED, AND 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 24507836 ↗
• MalfunctionFeb 13, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MICROCATHETER FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE GASTRODUODENAL ARTERY. A NGMC/TRANSEND/021/BERN/1RO/130 DIREXION WAS SELECTED FOR USE. AFTER UNPACKING, IT WAS NOTED THAT THE TAIL END OF THE MICROCATHETER 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 24332657 ↗
• MalfunctionJan 26, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MICROCATHETER FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER VESSEL. A NGMC/TRANSEND/021/BERN/1RO/130 DIREXION WAS SELECTED FOR USE. DURING THE INSERTION, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED INSIDE PATIENT. 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 24179453 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE TIP DETACHED. THIS NGMC/TRANSEND/021/BERN/1RO/155 DIREXION? TRANSEND?-14 SYSTEM WAS SELECTED FOR USE. IT WAS NOTED THAT THE DEVICE DETACHED FROM THE TIP AT THE EXIT LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771100 ↗
• MalfunctionSep 3, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE FRACTURED. A DIREXION? TRANSEND? 14 SYSTEM WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. DURING THE PROCEDURE, THE MICROCATHETER BODY FRACTURED DURING CATHETER TWISTING. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954388 ↗
• MalfunctionJul 2, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A DIREXION TRANSEND -14 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DISTAL TIP OF THE MICROCATHETER FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22388042 ↗
• MalfunctionJun 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT SHAFT RUPTURE OCCURRED. THE PATIENT UNDERWENT HEPATIC ARTERIAL CHEMOEMBOLIZATION. ARTERIOGRAPHY REVEALED THAT THE TARGET VESSEL WAS TORTUOUS. A DIREXION CATHETER-INFUSION WAS USED TO SUPERSELECT THE FEEDING ARTERY OF THE TUMOR. HOWEVER, DURING INTRODUCTION, THE END OF THE CATHETER RUPTURED OUTSIDE THE PATIENT, RESULTING IN THE INABILITY TO ROTATE. A NEW MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151842 ↗
• MalfunctionMar 31, 2025Fracture; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) IN THE LIVER. DURING THE PROCEDURE, THE MICROCATHETER WAS INSERTED INTO THE BLOOD VESSEL FOR NORMAL OPERATION. UPON WITHDRAWAL FROM THE BLOOD VESSEL, IT WAS FOUND THAT THE FRONT END OF THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733908 ↗
• MalfunctionDec 21, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05DEC2023. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE INSIDE THE CATHETER AND GOT KINKED AFTER REMOVED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. THE DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER WAS NOT IN A CORRECT POSITION AS THE PHYSICIAN WAS NOT SATISFIED ON THE INITIAL PLACEMENT OF THE COIL. THE PHYSICIAN WITHDRAWN THE DEVICE AND AFTER BEING FLUSHED WITH HEPARIN SALINE, IT WAS DEPLOYED AGAIN, HOWEVER, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCE INSIDE THE TAIL END OF THE CATHETER. THE DEVICE WAS REMOVED BY FOLLOWING THE CONTRAST DIRECTLY OUT OF THE BODY. WHEN CHECKED AFTER REMOVAL, IT WAS FOUND THAT THE MICROCATHETER WAS KINKED. THE PROCEDURE COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS FRACTURED 124.7CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380095 ↗
• MalfunctionOct 25, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE MICROCATHETER EXTERNAL SHEATH BROKE IN TWO PIECES. A DIREXION CATHETER WAS SELECTED FOR USE IN A RENAL EMBOLIZATION PROCEDURE TO TREAT A RENAL TUMOR. DURING THE PROCEDURE, WHEN ENTERING THE MICROCATHETER, THE EXTERNAL SHEATH WAS BROKEN IN TWO PIECES. THE PROBLEM WAS DISCOVERED BECAUSE IT WAS NOT POSSIBLE TO MOVE THE CATHETER FORWARD. THE MICROCATHETER WAS REMOVED OUT OF THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007166 ↗
• MalfunctionAug 10, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. DURING THE PREPARATION, THE COATING ON THE WIRE CAME OFF WHEN THE DOCTOR USED A WET GAUZE TO WIPE THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIREXION. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17501901 ↗
• MalfunctionJan 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE PURPLE (PROXIMAL) PART WAS SEPARATED FROM THE REST OF THE MICROCATHETER. THE CATHETER WAS NOT USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247689 ↗

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