VortX™ - 18 M0013812060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729201199), received between Aug 16, 2019 and May 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionMay 28, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE MAIN COIL COULD NOT BE ADVANCED THROUGH THE CATHETER. THE TARGET LESION WAS LOCATED IN A VENOUS EMBOLISM ASSOCIATED WITH PELVIC CONGESTION SYNDROME. A BSC STC18 MICROCATHETER WAS ADVANCED TO THE INTENDED RELEASE POSITION, AND A VORTX-18 6 MM X 6.5 MM COIL WAS SELECTED FOR USE. THE COIL INITIALLY ADVANCED WITHOUT ISSUE BUT ENCOUNTERED RESISTANCE IN THE DISTAL PORTION OF THE MICROCATHETER. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE COIL, INCLUDING SALINE FLUSHING AND GUIDEWIRE ASSISTANCE, BUT NONE WERE SUCCESSFUL. UPON WITHDRAWAL OF THE MICROCATHETER, IT WAS NOTED THAT THE COIL HAD ALREADY FORMED AND BECOME LODGED WITHIN THE MICROCATHETER LUMEN. THE GUIDEWIRE WAS RE-USED IN AN ATTEMPT TO DEPLOY THE COIL. THE GUIDEWIRE WAS ADVANCED INTO THE MID-PORTION OF THE COIL, AND THE ANGIOGRAPHY CATHETER WAS THEN USED TO DELIVER A FOAM SCLEROSING AGENT. FOLLOW-UP ANGIOGRAPHY PERFORMED AFTER 5 MINUTES DEMONSTRATED SLOWED FLOW WITH NO VISUALIZATION OF THE DISTAL PORTION OF THE MICROCATHETER. THE COIL WAS NOT IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS ASSOCIATED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322680 ↗
• MalfunctionApr 22, 2022Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30MAR2022. IT WAS REPORTED THAT THE COIL WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE LUNG. A 6MM/6.5 MM VORTX - 18 EMBOLICS WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE COIL WAS STRETCHED AND WAS NOT SUCCESSFULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187126 ↗
• MalfunctionAug 16, 2019Break; Break

  IT WAS REPORTED THAT COIL FRACTURE OCCURRED. THE TARGET LESION AREA WAS LOCATED IN A MEDIUM TORTUOUS SPLENIC ARTERY. A 6MMX6.5MM VORTX-18 WAS SELECTED FOR USE IN ARTERIAL ANEURYSM EMBOLIZATION. DURING THE PROCEDURE, THE COIL DEPLOYED IN THE LESION AFTER TUMOR WAS REACHED BY THE DELIVERY SYSTEM. THE COIL COULD NOT DEPLOYED UPON WITHDRAWAL AND WAS DETACHED. SUBSEQUENTLY, THE INTERLOCKING ARM OF THE COIL WAS DETACHED/UNLOCKED FROM THE PUSHER WIRE. THE COIL WAS SIMPLY REMOVED WITH THE CATHETER FROM THE PATIENT, AND THERE WERE NO DEVICE FRAGMENTS LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8901821 ↗