Direxion™ Transend™-14 System M001195810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729839743), received between Feb 23, 2021 and Oct 25, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 23, 2022Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03MAY2022. IT WAS REPORTED THAT THE DEVICE COULD NOT TRACK ON DIAGNOSTIC CATHETER. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE GASTROINTESTINAL AREA. A 130CM DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. THE DEVICE WAS HYDRATED 15 SECONDS PRIOR TO REMOVAL OF THE HOOP. UPON INTRODUCTION, THE DEVICE COULD NOT TRACK ON DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS FRACTURED 66.7CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14475568 ↗
• MalfunctionSep 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25AUG2021. IT WAS REPORTED THAT DEVICE HAD RESISTANCE AND WAS NOT TRACKING. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A DIREXION TRANSEND -14 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON ADVANCING THE MICROCATHETER INTO THE LESION, THE DEVICE COULD NOT TRACK AND SHOWED RESISTANCE. THE DEVICE WAS COMPLETELY REMOVED ALONG WITH THE DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT FRACTURE 46CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464360 ↗
• MalfunctionFeb 23, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT RESISTANCE WAS NOTED WHEN WITHDRAWING THE CATHETER. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NOT SO TORTUOUS AND MILDLY CALCIFIED ULNAR ARTERY. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. DELIVERY WAS MADE USING THE MICROCATHETER AND A CONTINUOUS SALINE FLUSH WAS MAINTAINED BETWEEN THE GUIDING CATHETER AND THE MICROCATHETER, AND BETWEEN THE MICROCATHETER AND THE GUIDEWIRE DURING THE PROCEDURE. DURING WITHDRAWAL, IT WAS NOTED THAT THERE WAS RESISTANCE IN WITHDRAWING THE DIREXION MICROCATHETER. THE DEVICE WAS REMOVED ALONG WITH THE 5F DIAGNOSTIC CATHETER AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS NOTED THAT EXCESSIVE FORCE WAS NOT REQUIRED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366855 ↗