GORE HELEX Septal Occluder HX2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132607006), received between May 20, 2019 and Nov 25, 2019 — classified as 1 injury, 1 malfunction.

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

• MalfunctionNov 25, 2019Fracture; Fracture

  IT WAS REPORTED A GORE® HELEX SEPTAL OCCLUDER WAS IMPLANTED TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD) ON (B)(6) 2014. ON AN UNRELATED FOLLOW-UP EXAM TO ASSESS A SURGICAL MITRAL VALVE REPAIR, A WIRE FRACTURE WAS NOTED ON THE LEFT DISC OF THE HELEX DEVICE. IT WAS ALSO NOTED THAT THE LOCK LOOP WAS NOT CAPTURING THE RIGHT EYELET OF THE DEVICE AND A SIGNIFICANT SHUNT WAS OBSERVED. THE PHYSICIAN SAID THAT DURING THE FUTURE SURGICAL PROCEDURE FOR THE MITRAL VALVE REPAIR, THE DEVICE WILL BE REMOVED AND THE ASD WILL BE SURGICALLY CLOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9370584 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 30MM GORE® HELEX® SEPTAL OCCLUDER ON (B)(6) 2014 TO CLOSE A PATENT FORAMEN OVALE. IN (B)(6) 2018, THE PATIENT PRESENTED WITH A STROKE AND ECHOCARDIOGRAPHY DEMONSTRATED A 7MM MASS ON THE LEFT ATRIAL DISC OF THE HELEX® DEVICE. THE PATIENT WAS PLACED ON COUMADIN.

  Patient problems: Stroke/CVA; Thrombus

  MAUDE report 8624550 ↗