Direxion™ Transend™-14 System M001195850Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729839781), received between Jul 29, 2022 and Apr 24, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 29, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE VESSEL WENT INTO SPASM AND COULD NOT REMOVE THE DEVICE. A 155CM DIRECTION CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE THE VESSEL WENT INTO SPASM. UPON REMOVAL, THE DEVICE COULD NOT BE REMOVED AND THE MICROCATHETER GOT BROKE AT THE HUB TWICE. THE PATIENT WAS GIVEN A GLYCERYL TRINITRATE AND REMOVED THE DEVICE SUCCESSFULLY WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 15136068 ↗