VortX™ - 18 M0013812040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729324850), received between Aug 16, 2019 and Aug 3, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionAug 3, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20JUL2020. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE MICROCATHETER. THE TARGET LESION AREA WAS LOCATED AT THE LIVER. A 4 MM/ 4 MM VORTX - 18 WAS SELECTED FOR AN ARTERIOVENOUS FISTULA EMBOLIZATION. DURING THE PROCEDURE, THE COIL GOT STUCK AT THE HUB PART OF THE MICRO CATHETER AND IT COULD NOT BE PUSHED. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10355941 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REBLEEDING WAS NOTED. THE TARGET LESION WAS IN THE KIDNEY VESSEL. A 4MM/4MM VORTX - 18 WAS USED FOR TREATMENT ON (B)(6) 2020 AFTER FIVE OTHER COILS WERE PLACED. POST PROCEDURE, IT WAS FOUND OUT THAT THE PATIENT WAS STILL BLEEDING THUS TREATED AGAIN ON (B)(6) 2020. THERE WAS NOTHING ABNORMAL WITH THE COIL AFTER IT WAS RELEASED SUCCESSFULLY. THE PHYSICIAN THOUGHT THE REBLEEDING WAS RELATED TO THE USER'S OPERATION METHOD AS IT WAS VERY DIFFICULT TO FIND THE BLEEDING SPOT BECAUSE THE KIDNEY ARTERY WAS BRITTLE AND THE PATIENT'S LESION WAS DIFFICULT TO EMBOLIZE. THE PATIENT'S CONDITION WAS STABLE AND THERE WERE NO FURTHER COMPLICATIONS REPORTED. IT WAS NOTED THAT IF THE REBLEEDING COULD NOT BE CONTROLLED, THE PATIENT WOULD NEED TO UNDERGO INTERVENTIONAL SURGERY AGAIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10116845 ↗
• MalfunctionAug 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  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 8901799 ↗