VortX™ Diamond - 18 M0013822030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729324874), received between May 9, 2019 and Apr 6, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11MAR2022. IT WAS REPORTED THAT THE COIL WAS STUCK INSIDE THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE RENAL AREA. A 18 3MM/3.3 MM VORTX DIAMOND-18 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INTERMITTENTLY HYDRATED. WHEN THE DOCTOR ATTEMPTED TO PUSH THE DEVICE, THE COIL GOT STUCK IN THE MIDDLE OF THE MICROCATHETER AND COULD NOT BE PUSHED ANY FURTHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS DOING GOOD POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE FIBER BUNDLES WERE INCOMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14026885 ↗
• MalfunctionMay 5, 2020Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. IT WAS REPORTED THAT THE COIL FAILED TO SEPARATE. THE TARGET LESION AREA WAS LOCATED IN THE FUNDUS OF THE STOMACH. A 3MM/3.3MM VORTX-18 DIAMOND EMBOLIC WAS SELECTED FOR USE. DURING THE PROCEDURE, COIL DEPLOYMENT FAILED. THE DEVICE WAS REMOVED ALL TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS NOT RETURNED. IT WAS FURTHER REPORTED THAT THE COIL WAS SCRAPPED BY THE PHYSICIAN AFTER IT WAS COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026037 ↗
• MalfunctionNov 5, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE MICROCATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VEIN. A 3MM/3.3 MM VORTX DIAMOND 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK INSIDE THE MICROCATHETER. THE COIL WAS REMOVED TOGETHER WITH THE MICRO CATHETER; HOWEVER, IT WAS FURTHER NOTED THAT THE COIL PROTRUDED FROM THE MICROCATHETER'S TIP DURING REMOVAL AND WAS FOUND BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279465 ↗
• MalfunctionMay 9, 2019Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE WAS "JUMPED OUT" FROM THE PACKAGE. A TARGET AREA WAS LOCATED IN A MILDLY TORTUOUS HEPATIC ARTERY. A 3MM/3.3 MM VORTX DIAMOND COIL WAS SELECTED FOR USE. DURING THE PREPARATION, WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE, THE DEVICE "JUMPED OUT" FROM THE BAG. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595175 ↗