VortX™ - 35 M0013732040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729237273), received between Mar 17, 2020 and May 5, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COIL PEELED. A VORTX - 35 COIL WAS SELECTED FOR A HEPATIC EMBOLIZATION PROCEDURE. IT WAS NOTED THAT THE COIL PEELED IN THE GUIDE. THE PROCEDURE WAS COMPLETED WITH A 4MM VORTX COIL AND A 5MM 2D HELICAL COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10025741 ↗
• MalfunctionMar 17, 2020Stretched; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem; Stretched; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT COIL FRACTURE OCCURRED. A 2MMX4MM VORTX- 35 COIL WAS SELECTED FOR USE LOCALIZATION WITH COIL PROCEDURE PRIOR TO RADIOTHERAPY OF A LUNG TUMOR. THE TARGET LESION WAS A MILD TO NONE TORTUOUS. DURING THE PROCEDURE, THE COIL WAS INTRODUCED INTO THE NON-BSC CATHETER, A GUIDEWIRE WAS USED TO PUSH THE COIL THROUGH THE CATHETER. THE COIL WAS INTERMITTENT FLUSHED OUT. WHEN THE DISTAL PART OF THE COIL CAME OUT OF THE TIP OF THE CATHETER IT WAS NOTICED THAT THE COIL WAS VERY STRETCHED AND DID NOT FORM THE SHAPE. THE PHYSICIAN PULLED OUT THE GUIDEWIRE AND NOTICED THAT THERE WAS A VERY THIN WIRE OF THE COIL LOCATED AT THE HUB. THE COIL WAS REMOVED WITH THE CATHETER FROM THE PATIENT BY PULLING OUT THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE COIL AND CATHETER DEVICES AND EVERYTHING WAS FINE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS OK POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE COIL WAS STRETCHED FROM THE HUB UNTIL THE TIP OF THE CATHETER AND THERE WAS NOTHING DETACHED FROM THE MAIN COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842389 ↗