Direxion™ Transend™-14 System M001195840Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729839774), received between Jan 21, 2020 and Sep 22, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16 most recent of 16 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 4, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13DEC2022. IT WAS REPORTED THAT THE DEVICE WAS KINKED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS VESSEL. A DIREXION CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN INTRODUCING THE DIREXION THROUGH 5F CATHETER, IT WAS DIFFICULT TO BE PUSHED FORWARD. CONSEQUENTLY, THE DEVICE WAS REMOVED AND FOUND IT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS FRACTURED APPROX. 40.5CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099248 ↗
• MalfunctionSep 16, 2022Mechanical Problem; Obstruction of Flow; Material Integrity Problem; Mechanical Problem; Obstruction of Flow; Material Integrity Problem

  IT WAS REPORTED THAT THE IMAGE WERE NOT CLEAR UNDER FLUOROSCOPY. THE TARGET LESION WAS LOCATED IN THE HEPATIC ARTERY. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WITH POOR LIQUIDITY WAS ADVANCE INTO THE MICROVASCULATURE WITH THE HELP OF THE RH CATHETER. THE 2ML CONTRAST WAS INJECTED WITH DIFFICULTY. EVEN WITH HIGH-PRESSURE SYRINGE TO INJECT THE CONTRAST, THE IMAGE WAS NOT CLEAR, AND IT WAS NOTED THAT THE CATHETER COULD HARDLY BE SEEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437983 ↗
• MalfunctionSep 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PLASTIC OUTER MEMBRANE OF THE MICROCATHETER FALLS OFF. THE LESS THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERY IN THE RIGHT LOBE OF THE LIVER. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE MICROCATHETER WAS INSIDE THE PATIENT, THE CONTROL WAS ABNORMAL SO THE PHYSICIAN TOOK IT OUT AND FOUND THAT THE PLASTIC OUTER MEMBRANE OF THE MICROCATHETER FALLS OFF AND IS DAMAGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458022 ↗
• MalfunctionAug 7, 2020Break; Break

  IT WAS REPORTED THAT MICRO CATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE HEPATIC ARTERY. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, INTRA-ABDOMINAL ANGIOGRAPHY OF THE HEPATIC DUCT THAT WENT DEEP INTO THE DISTAL COMMON HEPATIC ARTERY WAS PERFORMED. SUBSEQUENTLY, THE MICROCATHETER WAS USED TO PERFORM ANGIOGRAM INTO THE BRANCH OF THE PROPER HEPATIC ARTERY, HOWEVER THE DEVICE WAS FRACTURED DURING SEVERAL INJECTIONS OF THE MICROSPHERE. THE DEVICE WAS THEN SIMPLY PULLED OUT COMPLETELY 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 10379022 ↗
• MalfunctionJan 21, 2020Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER BROKE. A 130 DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE OUTER TUBING OF THE MICROCATHETER BROKE INTO TWO PLACES UPON NAVIGATION. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610480 ↗