VortX™ - 18 M0013812050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729324867), received between Oct 19, 2020 and Sep 23, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31AUG2021. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED. THE TARGET LESION WAS LOCATED IN A PULMONARY NODULE. A 5 MM/ 5.5 MM VORTX - 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DELIVERED AND FAILED TO ADVANCE THE COIL INSIDE A PUNCTURE NEEDLE. THE DEVICE WAS SIMPLY PULLED OUT AND 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 THE ZAP TIP OF THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519874 ↗
• MalfunctionJul 27, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08JUL2021. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED AT HALFWAY AND SHEATH COULD NOT BE PUSHED. THE TARGET LESION WAS LOCATED IN THE GASTRIC ARTERY. A 5MM/5.5MM VORTX - 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE DELIVERED AT HALFWAY, AND THE PHYSICIAN COULD NOT PUSH SHEATH AFTER MANY ATTEMPTS. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230291 ↗
• MalfunctionJun 14, 2021Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED FROM THE CATHETER AND THE TAIL END OF THE COIL WAS FOLDED. THE TARGET LESION WAS LOCATED IN THE CHEST. A 5MM/5.5MM VORTX-18 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED FROM THE CATHETER, THE TAIL END OF THE COIL WAS FOLDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ZAP TIPS OF THE MAIN COIL WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996888 ↗
• MalfunctionMar 26, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11MAR2021. IT WAS REPORTED THAT THE COIL GOT STUCK. A 5MM/5.5 MM VORTX-18 EMBOLIC WAS SELECTED FOR USE. DURING THE PROCEDURE. THE COIL WAS ADVANCED INTO THE CATHETER. HOWEVER, IT COULD NO LONGER PASS WHEN IT REACHED THE DISTAL PART OF THE CATHETER AND WAS STUCK. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED LOSS OF FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575489 ↗
• MalfunctionOct 19, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05OCT2020. IT WAS REPORTED THAT DEVICE COULD NOT BE ADVANCED. THE TARGET LESION AREA WAS LOCATED IN THE SPLENIC ARTERY. A 5MM/5.5 MM VORTX-18 WAS SELECTED FOR USE. DURING EMBOLIZATION, THE PHYSICIAN COULD NOT ADVANCE THE COIL THROUGH THE MICROCATHETER HUB OF A NON-BOSTON SCIENTIFIC DEVICE FROM THE COIL INTRODUCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS AND THE PATIENT'S CONDITION AFTER THE PROCEDURE IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE ARE MISSING FIBERS AND THE ZAP TIP WAS DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701260 ↗