Direxion™ M001195210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729839323), received between Mar 8, 2019 and Mar 19, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2024Detachment of Device or Device Component; Material Integrity Problem; Poor Visibility; Detachment of Device or Device Component; Material Integrity Problem; Poor Visibility

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED REQUIRING SNARE FOR REMOVAL. A DIREXION MICROCATHETER WAS SELECTED FOR ABDOMINAL EMBOLIZATION. DURING COIL DEPLOYMENT, IT WAS NOTED THAT A TINY PIECE OF MICROCATHETER BROKE INSIDE THE PATIENT'S BODY. THE BROKEN PIECE WAS VERY HARD TO VISUALIZE UNDER FLUOROSCOPY. THE DETACHED PORTION OF THE DEVICE WAS REMOVED BY SNARE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933292 ↗
• MalfunctionJan 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION MICROCATHETER WAS SELECTED FOR USE ON THE LIVER. DURING THE PROCEDURE, THE DEVICE WAS USED ONCE FOR ANGIOGRAPHY WITHOUT ISSUE AND WAS REMOVED INTACT. WHEN THE PHYSICIAN WAS ABOUT TO RE-ENTER THE PATIENT'S BODY FOR ANOTHER ANGIOGRAPHY, IT WAS NOTED THAT THE DEVICE WAS FRACTURED AT THE MIDDLE OF THE MICROCATHETER, ABOUT 50CM FROM THE HANDLE. 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 16164853 ↗
• MalfunctionSep 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER WAS PEELING OFF. A 130CM DIREXION INFUSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE OUTSIDE LAYER OF THE CATHETER STARTED PEELING OFF AS IT WENT THROUGH THE GATEWAY PLUS Y-ADAPTER. THE CATHETER WAS REMOVED AND A DIFFERENT MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555066 ↗
• MalfunctionJul 28, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. MIDWAY THROUGH THE PROCEDURE, THE CATHETER BROKE INTO TWO PIECES. BOTH PIECES WERE REMOVED FROM THE BODY AND NO ADDITIONAL INTERVENTION WAS REQUIRED FOR REMOVAL. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10333422 ↗
• MalfunctionAug 9, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS SEPARATED. THE TARGET LESION WAS LOCATED AT THE LIVER. A SINGLE 021 STRAIGHT 1RO 130 NGMC WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER WAS FOUND TO BE SEPARATED IN THE MIDDLE. THE KINK IN THE CATHETER CONTRIBUTED TO THE EVENT. SUBSEQUENTLY, THE DEVICE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE WIRE. THERE WAS NO INTERVENTION DONE TO REMOVE THE DEVICE AND NO COMPONENT OF THE DEVICE THAT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT IS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879009 ↗
• MalfunctionMar 8, 2019Break; Break

  IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. A DIREXION INFUSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE CATHETER BROKE WHILE IN USE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8403742 ↗