GORE HELEX Septal Occluder HX2035Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132607013), received between Feb 20, 2020 and Feb 20, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 35MM GORE® HELEX SEPTAL OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT ON (B)(6) 2014. DURING THE INITIAL PROCEDURE, A 30MM GORE® HELEX SEPTAL OCCLUDER WAS INITIALLY SELECTED AND DEPLOYED BUT WAS TOO SMALL FOR THE DEFECT AND WAS REMOVED. THE PHYSICIAN THEN SELECTED THE 35MM GORE® HELEX SEPTAL OCCLUDER WHICH WAS IMPLANTED DESPITE A "VOLUMINOUS SHUNT". THE DEFECT WAS NOT BALLOON SIZED. IN (B)(6) 2019, THE PATIENT PRESENTED WITH A TRANSIENT ISCHEMIC ATTACK. ON (B)(6) 2020, THE PATIENT HAD A POSITIVE BUBBLE STUDY, INDICATING A SHUNT AND WAS REFERRED FOR SURGERY. THE PHYSICIAN LATER OPTED TO CLOSE THE SHUNT WITH A 35MM CRIBRIFORM, WHICH WAS IMPLANTED OVER THE HELEX DEVICE ON (B)(6) 2020. THE PATIENT UNDERWENT TRANSTHORACIC ECHOCARDIOGRAPHY (B)(6) 2020 THAT SHOWED NO RESIDUAL SHUNT BY COLOR FLOW DOPPLER. THE PATIENT IS DOING WELL.

  Patient problems: Transient Ischemic Attack

  MAUDE report 9734869 ↗