GORE CARDIOFORM Septal Occluder GSX0020ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132631018), received between Sep 7, 2021 and Aug 13, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryAug 13, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 20MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A MULTI FENESTRATED ATRIAL SEPTAL DEFECT. THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THIS SMALLER DEVICE IN THE SMALLER OF THE TWO DEFECTS. UNKNOWINGLY THE DEVICE WAS ADVANCED THROUGH THE LARGER DEFECT. THE DEVICE WAS LOCKED AND RELEASED. SHORTLY AFTER REMOVING THE RETRIEVAL CORD THE DEVICE EMBOLIZED. THE DEVICE WAS REMOVED WITH A SNARE FROM THE ABDOMINAL AORTA. THE PHYSICIAN STOPPED THE CASE AND WILL REASSESS THE PATIENT AT A LATER DATE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 19972462 ↗
• InjuryMay 9, 2024Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  IT WAS REPORTED THE PHYSICIAN SELECTED A 20MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A FENESTRATED FONTAN. THE DEVICE WAS PLACED WITHOUT ISSUE. THE FOLLOWING DAY, X-RAY SHOWED WHAT APPEARED TO BE AN UNLOCKED DEVICE. THE PHYSICIAN PLACED A STENT AND PUSHED THE RIGHT ATRIAL DISC AGAINST THE WALL OF THE FONTAN BAFFLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282661 ↗
• InjurySep 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 20MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT IN 2015. A MINOR SHUNT WAS NOTED FOLLOWING THE PROCEDURE, BUT NO ADDITIONAL ACTION WAS TAKEN. THE PATIENT WAS ROUTINELY IMAGED. RECENT TRANSESOPHAGEAL ECHOCARDIOGRAPHIC (TEE) IMAGING SHOWED RIGHT HEART ENLARGEMENT SO THE PHYSICIAN BROUGHT THE PATIENT IN FOR SHUNT CLOSURE ON (B)(6) 2023. PRIOR TO THE PROCEDURE, THE PATIENT PRESENTED WITH INTERMITTENT HEART BLOCK. THE PHYSICIAN ASSESSED (TEE) THE DEFECT TO BE 3-5MM. A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED WITH GOOD RESULT.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 17777898 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 20MM GORE® CARDIOFORM SEPTAL OCCLUDER. TWO HOURS FOLLOWING THE PROCEDURE A PERICARDIAL EFFUSION WAS NOTED AND THE PATIENT WAS TREATED WITH A PERICARDIOCENTESIS. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. THE PHYSICIAN WAS UNSURE IF IT WAS THE DEVICE OR GUIDE WIRE THAT CAUSED THE ISSUE.

  Patient problems: Pericardial Effusion

  MAUDE report 12433516 ↗