GORE HELEX Septal Occluder HX2025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132606993), received between Jan 10, 2019 and Jun 5, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A GORE® HELEX SEPTAL OCCLUDER WAS IMPLANTED ON (B)(6) 2014 TO CLOSE AN ATRIAL SEPTAL DEFECT. THE PATIENT GOT A VIRAL INFECTION WHILE ON A CRUISE. AFTER THEY GOT BACK, THEIR PHYSICIAN FOUND A LARGE MASS ON THE LEFT DISC OF THE DEVICE. THE MASS WAS DESCRIBED AS VEGETATIVE GROWTH. ON (B)(6) 2024, IN A SURGICAL PROCEDURE, THE DEVICE WAS REMOVED, AND THE DEFECT WAS CLOSED WITH A PATCH. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Endocarditis

  MAUDE report 19471921 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 25MM GORE® HELEX® SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE ON (B)(6) 2014 IN A PATIENT WITH A HISTORY OF STROKE. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A STROKE. TRANSESOPHAGEAL IMAGING PERFORMED ON (B)(6) 2019 SHOWED A THROMBUS ON THE LEFT SIDE OF THE HELEX® DEVICE. THE PATIENT WAS LOST TO FOLLOW-UP AFTER THE HELEX® IMPLANT AND REPORTED HE HAS NOT BEEN COMPLIANT WITH THE RECOMMENDED ANTICOAGULANTS. THE PATIENT WAS PRESCRIBED ANTICOAGULANTS AND SCHEDULED FOR FOLLOW-UP IN ONE MONTH. IN (B)(6) 2019, THE PATIENT PRESENTED WITH ANOTHER STROKE AND LEFT SIDE PARALYSIS. THE PATIENT WAS DISCHARGED UNDER HOSPICE CARE.

  Patient problems: Stroke/CVA; Thrombus

  MAUDE report 8749415 ↗
• InjuryJan 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT RECEIVED A GORE® HELEX® SEPTAL OCCLUDER IMPLANT IN 2015 TO TREAT A PATENT FORAMEN OVALE. APPROXIMATELY TWO MONTHS AGO A SIGNIFICANT SHUNT WAS NOTED AND IT APPEARED AS THOUGH A COUPLE OF THE RIGHT DISC LEAFLETS HAD PROLAPSED. A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO CLOSE THE SHUNT; HOWEVER, FOLLOWING DEPLOYMENT A SIGNIFICANT RESIDUAL SHUNT WAS NOTED ON ECHOCARDIOGRAPHY AND THE DEVICE WAS REMOVED. A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS THEN SELECTED, HOWEVER, WHEN THE DEVICE WAS LOCKED, FLUOROSCOPY REVEALED A MISSED RIGHT ATRIAL EYELET. THIS DEVICE WAS REMOVED AND A SECOND 30MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE GORE® HELEX® SEPTAL OCCLUDER ALSO REMAINS IMPLANTED. FURTHER DISCUSSION BETWEEN THE FIELD SALES ASSOCIATE AND THE PHYSICIAN INDICATED IT WAS FELT THAT THIS WAS ANOTHER DEFECT/FENESTRATION; HOWEVER, THIS HAS NOT BEEN CONFIRMED.

  Patient problems: No Code Available

  MAUDE report 8233140 ↗