Direxion™ M001195200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729839316), received between Oct 19, 2018 and Mar 29, 2022 — classified as 3 malfunctions.

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

• MalfunctionMar 29, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS FELT AND THE DEVICE SNAPPED. THE MICROCATHETER WAS TAKEN OUT AND A FRACTURE WAS OBSERVED IN THE MIDDLE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943748 ↗
• MalfunctionSep 24, 2021Material Twisted/Bent; Material Twisted/Bent

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03SEP2021. IT WAS REPORTED THAT THE DEVICE WAS BENT. THE TARGET LESION WAS LOCATED IN THE ILIAC AREA. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PREPARATION, THE CATHETER SURFACE WAS HYDRATED PRIOR TO REMOVAL FROM CARRIER HOOP. HOWEVER, IT WAS NOTED THAT THE DEVICE GOT BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS FRACTURED 25.5CM FROM THE HUB. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS NOTED UPON FULLY REMOVING THE DEVICE FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528450 ↗
• MalfunctionOct 19, 2018Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A 021 STRAIGHT 1RO/105 DIREXION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN TRACKING THE DEVICE THROUGH THE ANATOMY, IT WAS NOTED THAT THE CORE OF THE NITINOL LAYER CRACKED AND SPLIT APART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS POST-PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984766 ↗