Direxion™ M001195280Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729839392), received between Oct 25, 2021 and Dec 20, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Fracture; Fracture

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-DEC-2022. IT WAS REPORTED THAT A FRACTURE OCCURRED. TWO DIREXION CATHETERS WERE SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETERS FRACTURED A FEW CENTIMETERS FROM THE HUB ON A PORTION OF THE DEVICE EXTERNAL TO THE PATIENT. THE PROCEDURE WAS CANCELLED DUE TO UNFAVORABLE ANATOMY. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURE 32.7CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016083 ↗
• MalfunctionApr 1, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. TWO NGMC/FATHOM/021/BERN/1RO/130 DIREXION FATHOM-16 SYSTEM WERE SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE GOT STUCK IN THE CATHETER WAS NOTED. A NEW J-SHAPE DIREXION CATHETER WAS OPENED, HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS THEN ABORTED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972261 ↗
• MalfunctionOct 25, 2021Fracture; Fracture

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04OCT2021. IT WAS REPORTED THAT DEVICE FRACTURED AT THE HUB. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. THE CATHETER SURFACE WAS HYDRATED PRIOR TO REMOVAL FROM CARRIER HOOP. HOWEVER, UPON REMOVING THE CATHETER FROM THE HOOP, THE NITINOL TUBING WAS DISCONNECTED FROM THE HUB DUE TO EXCESSIVE FORCE BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS SEPARATED 30.5CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689607 ↗