Direxion™ M001195250Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729839361), received between Apr 22, 2019 and Apr 4, 2022 — classified as 2 injuries, 7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DIREXION MICROCATHETER BECAME STUCK IN THE VESSEL. A DIREXION MICROCATHETER WAS SELECTED FOR THE PROSTATIC ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE MICROCATHETER BECAME STUCK IN THE VESSEL AND WAS DIFFICULT TO WITHDRAW. THE PHYSICIAN CUT OFF THE HUB OF THE MICROCATHETER TO REMOVE THE 5 FRENCH GUIDE CATHETER. A NON-BSC MICROSNARE KIT WAS USED TO REMOVE THE DIREXION MICROCATHETER FROM THE VESSEL. A SECOND DIREXION MICROCATHETER WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS ENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, THE PATIENT WAS HOSPITALIZED BEYOND THE STANDARD OF CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13997176 ↗
• InjuryApr 4, 2022Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DIREXION MICROCATHETER BECAME STUCK IN THE VESSEL. A DIREXION MICROCATHETER WAS SELECTED FOR THE PROSTATIC ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE MICROCATHETER BECAME STUCK IN THE VESSEL AND WAS DIFFICULT TO WITHDRAW. THE PHYSICIAN CUT OFF THE HUB OF THE MICROCATHETER TO REMOVE THE 5 FRENCH GUIDE CATHETER. A NON-BSC MICROSNARE KIT WAS USED TO REMOVE THE DIREXION MICROCATHETER FROM THE VESSEL. A SECOND DIREXION MICROCATHETER WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS ENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, THE PATIENT WAS HOSPITALIZED BEYOND THE STANDARD OF CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13997154 ↗
• MalfunctionNov 3, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11OCT2021. IT WAS REPORTED THAT THE MICROCATHETER WAS KINKED AND UNABLE TO DELIVER COIL. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED AND UPON DEPLOYMENT, IT WAS NOTED THAT THE MICROCATHETER WAS KINKED AND UNABLE TO DELIVER THE COIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748492 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT THE HYPOTUBE BROKE AND COIL MISDEPLOYED. A DIREXION CATHETER INFUSION AND A 2/4MM X 4.1CM F-IDC VORTX DIAMOND COIL WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE NITINOL HYPOTUBE BROKE IN TWO LOCATIONS. THE VORTX COIL MISDEPLOYED AND HAD TO BE REMOVED THROUGH SNARE. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238035 ↗
• MalfunctionJun 9, 2021Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING OF DIREXION WAS SEPARATED/BROKEN. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING PROCEDURE, THE MICROCATHETER STARTED TO DRAG AND BECAME STUCK INSIDE 4FR ACCESS CATHETER. "PHYSICIAN" SUSPECTED THAT THE COATING HAS SEPARATED/BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971070 ↗
• MalfunctionAug 18, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER SPLIT. A DIREXION CATHETER INFUSION WAS SELECTED FOR USE. IT WAS NOTED THAT THE CATHETER WAS SPLIT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10422428 ↗
• MalfunctionApr 23, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. DURING PROCEDURE, A DIREXION CATHETER BROKE UPON ADVANCING INTO THE VESSEL BEFORE INJECTING BEADS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991214 ↗
• MalfunctionApr 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT MICROCATHETER WAS FRACTURED. THE TARGET LESION WAS IN THE GASTRODUODENAL ARTERY. A 155 DIREXION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED AND WAS SIMPLY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933553 ↗
• MalfunctionApr 22, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2019. IT WAS REPORTED THAT THE CATHETER WAS KINKED. A DIREXION INFUSION CATHETER WAS SELECTED FOR USE. THE CATHETER WAS INSERTED INTO THE PATIENT, HOWEVER, IT WAS KINKED SO THE GUIDEWIRE WAS UNABLE TO PASS THROUGH THE CATHETER. A SECOND DIREXION INFUSION CATHETER WAS THEN SELECTED, HOWEVER, WHEN IT WAS REMOVED OUT OF THE HOOP IT WAS STRETCHED. A THIRD DIREXION WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURE LOCATED 34.7 CM FROM THE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536226 ↗