VortX™ Diamond - 18 M0013822050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729324898), received between Nov 11, 2019 and Sep 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Advance; Malposition of Device

  Patient problems: Pneumothorax

  MAUDE report 50946993 ↗
• MalfunctionMay 17, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED THE CATHETER'S TIP DURING REMOVAL. A 5MM/5.5 MM VORTX DIAMOND WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER. WHEN CATHETER AND COIL WERE REMOVED, THE COIL PROTRUDED FROM THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11834876 ↗
• MalfunctionSep 16, 2020Entrapment of Device; Stretched; Entrapment of Device; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01SEP2020. IT WAS REPORTED THAT THE COIL BECAME STUCK IN ITS SHEATH. THE TARGET LESION AREA WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. A 5MM/5.5 MM VORTX DIAMOND -18 WAS SELECTED FOR USE IN A LIVER CHEMOEMBOLIZATION. DURING PREPARATION, AFTER THE DEVICE WAS FLUSHED, THE COIL GOT STUCK IN ITS SHEATH AND PART OF THE COIL STRETCHED FROM OUT SIDE. THE COIL AND THE MICROCATHETER WERE PULLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED. THE PATIENT IS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED INCOMPLETE FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541953 ↗
• MalfunctionDec 5, 2019Contamination; Contamination

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. A VORTX DIAMOND-18 DEVICE WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. AS THE DEVICE WAS BEING REMOVED FROM THE INNER PACKAGING, THE PUSHER JUMPED OUT OF THE PACKAGING. THE STERILITY WAS COMPROMISED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9416790 ↗
• MalfunctionNov 11, 2019Entrapment of Device; Fracture; Entrapment of Device; Fracture

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19OCT2019. IT WAS REPORTED THAT COIL DID NOT COME OUT OF THE SHEATH. A 5MM/5.5MM VORTX DIAMOND - 18 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE COIL COULD NOT PASS THROUGH THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE FIBER BUNDLES WERE INCOMPLETE.

  Patient problems: No Patient Involvement

  MAUDE report 9304420 ↗