GORE CARDIOFORM Septal OccluderRecalls & reported problems across all models

We found 3 models of GORE CARDIOFORM Septal Occluder by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 240 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2018 and Sep 21, 2026 — classified as 1 death, 226 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (42 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GORE CARDIOFORM Septal Occluder recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 14, 2022Class IIOpen, Classified

   Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.

   Z-1048-2023 · Root cause: Employee error · Recall details · FDA record ↗

Most reported GORE CARDIOFORM Septal Occluder problems

GORE CARDIOFORM Septal Occluder models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE CARDIOFORM Septal Occluder GSX0030A

  Transcatheter Septal Occluder
  1 recall143 reports
• GORE CARDIOFORM Septal Occluder GSX0025A

  Transcatheter Septal Occluder
  1 death93 reports
• GORE CARDIOFORM Septal Occluder GSX0020A

  Transcatheter Septal Occluder
  4 reports

Recent GORE CARDIOFORM Septal Occluder adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Difficult or Delayed Positioning

  It was reported the physician was implanting a 30mm GORE® CARDIOFORM Septal Occluder to close a long tunnel, aneurysmal Patent Foramen Ovale. Both disc did not oppose the septum well, so the device was repositioned twice. On the third attempt, the left disc prolapsed into the tunnel. The device was deployed again, and a shunt was still present. The device was removed in favor of trying a larger device. At this point, the patient became symptomatic and a Pericardial Effusion was noted in the superior portion of the left atrium. The patient was treated with a Pericardiocentesis. The patient was sent for surgical repair of the effusion and closure of the PFO. The patient was doing well following the surgery.

  Patient problems: Pericardial Effusion

  MAUDE report 50841333 ↗
• InjurySep 2, 2026Difficult or Delayed Positioning; Migration

  Patient problems: Foreign Body Embolism

  MAUDE report 50571013 ↗
• InjuryMay 22, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A LONG TUNNEL (11MM TUNNEL) PATENT FORAMEN OVALE. THE PHYSICIAN GAINED ACCESS ACROSS DEFECT WITHOUT ANY COMPLICATIONS. WIRE WAS PLACED IN THE LEFT UPPER PULMONARY VEIN. DURING DEPLOYMENT THE PHYSICIAN NOTED FEELING RESISTANCE. ECHOCARDIOGRAPHY SHOWED THE DEVICE WAS STILL IN THE LONG TUNNEL. THE DEVICE WAS RECAPTURED AND REPOSITIONED. DURING THE SECOND DEPLOYMENT ATTEMPT THE LEFT DISC FORMED COMPLETELY. HOWEVER, DURING DEPLOYMENT OF THE RIGHT DISC, IT PROLAPSED IN A LAO/CRAN POSITION. THE RIGHT DISC WAS THEN RECAPTURED, ROTATED POSTERIORLY AND REDEPLOYED. A THIRD DEPLOYMENT ATTEMPT WAS PERFORMED BY PULLING THE LEFT DISC BACK ONTO THE SEPTUM SHOWING ADEQUATE CUPPING FOLLOWED BY FULL DEPLOYMENT OF THE RIGHT DISC. AT THIS TIME, THE RIGHT DISC APPEARED FLUSH WITH THE SEPTUM AND DIAMETER WAS SIMILAR TO LEFT DISC. THE DEVICE WAS THEN LOCKED AND RELEASED. SUBSEQUENT EVALUATION WITH ICE IMAGING IDENTIFIED A PERICARDIAL EFFUSION MEASURING APPROXIMATELY 8 MM. THE PATIENT REMAINED IN NORMAL SINUS RHYTHM WITH BLOOD PRESSURE AT 112/60 MMHG BUT BECAME DIAPHORETIC. A PERICARDIOCENTESIS WAS PERFORMED, WITH APPRO

  Patient problems: Pericardial Effusion

  MAUDE report 25257572 ↗
• InjuryMay 5, 2026Malposition of Device

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE. THE DEVICE WAS ADVANCED AND DEPLOYED. UPON DEVICE LOCKING, THE MANDREL MOVED INTO THE CONTROL CATHETER TIP SLOT AND PREVENTED THE LOCK LOOP FROM ACTUATING. THE PHYSICIAN UNSCREWED THE DELIVERY CATHETER LUER AND ADVANCED THE CATHETER TO REALIGN THE DEVICE. THE LOCK LOOP RELEASED, AND THE DEVICE WAS IMPLANTED. AFTER DEPLOYMENT, A SMALL PERICARDIAL EFFUSION WAS NOTED, WHICH WAS ATTRIBUTED TO THE PATIENT¿S ANATOMY AND DEVICE MANIPULATION ASSOCIATED WITH THE TIP SLOT ISSUE DESCRIBED ABOVE. APPROXIMATELY 22CC'S WAS DRAINED AND PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 25083399 ↗
• InjuryApr 30, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THAT A 25 MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATENT FOREMAN OVALE (PFO). REPORTEDLY, THE PFO WAS CROSSED WITHOUT ISSUE AND WAS INITIALLY POSITIONED APPROPRIATELY; THE DEFECT WAS NOT BALLOON SIZED. DURING DEPLOYMENT OF THE LEFT ATRIAL DISC, THE DISC APPEARED TO DEPLOY WITHIN THE PFO TUNNEL. THE PHYSICIAN RETRACTED THE DISC INTO THE DELIVERY SYSTEM, ADVANCED THE SYSTEM, AND ATTEMPTED REDEPLOYMENT, BUT THE DISC APPEARED "SQUISHED". THE ENTIRE DELIVERY SYSTEM WAS REMOVED, AND A NEW DEVICE OF THE SAME SIZE WAS SUCCESSFULLY DEPLOYED WITHOUT ISSUE. FOLLOWING DEVICE IMPLANT, THE PATIENT EXPERIENCED A REACTION TO A PROTAMINE TEST DOSE AND HAD ALSO DEVELOPED A PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS, WHICH WAS ASSESSED BY THE PHYSICIAN AS BEING RELATED TO THE FIRST DEVICE ATTEMPTED. THE PATIENT ULTIMATELY TOLERATED THE PROCEDURE AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pericardial Effusion

  MAUDE report 25047508 ↗
• InjuryApr 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED; THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2026. AT A FOLLOW-UP APPOINTMENT ON (B)(6) 2026, A THROMBUS WAS NOTED ON THE DEVICE. THE PATIENT WAS TREATED WITH HEPARIN. THE REASON THE PATIENT WENT IN FOR AN EARLY ECHO WAS A REPORT OF ATRIAL FIBRILLATION, WHICH HAS SINCE RESOLVED WITH NO TREATMENT.

  Patient problems: Atrial Fibrillation; Thrombosis/Thrombus

  MAUDE report 24999819 ↗
• InjuryApr 21, 2026Patient-Device Incompatibility

  IT WAS REPORTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED ON (B)(6)2025 TO TREAT A PATENT FORAMEN OVALE. ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH ATRIAL FIBRILLATION AND WAS PRESCRIBED ELIQUIS.

  Patient problems: Atrial Fibrillation

  MAUDE report 24944337 ↗
• InjuryApr 17, 2026Migration

  IT WAS REPORTED THAT A 30 MM GORE® CARDIOFORM SEPTAL OCCLUDER (GSO) WAS IMPLANTED TO CLOSE AN IATROGENIC ATRIAL SEPTAL DEFECT (IASD) DURING THE SAME PROCEDURE IN WHICH THE PATIENT RECEIVED AN EDWARDS M3 VALVE IMPLANT ON (B)(6), 2026. AT AN UNKNOWN POINT FOLLOWING THE PROCEDURE, THE PATIENT¿S CONDITION BEGAN TO DECLINE. ON (B)(6) 2026, IMAGING REVEALED THAT THE 30 MM GSO HAD EMBOLIZED INTO THE RIGHT PULMONARY ARTERY (PA). THE DEVICE WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PA WITHOUT REPORTED COMPLICATIONS. A 44 MM GORE® CARDIOFORM ASD OCCLUDER (GCA) WAS SUBSEQUENTLY IMPLANTED. REVIEW OF FLUOROSCOPIC IMAGES BY THE FIELD SALES ASSOCIATE ON APRIL 6, 2026, INDICATED THAT THE ORIGINAL IASD WAS LARGE, MEASURING APPROXIMATELY 21 MM, AND POST-DEPLOYMENT IMAGES OF THE 30 MM DEVICE SHOWED RESIDUAL LEAKS AROUND THE DEVICE, SUGGESTING THE DEFECT MAY NOT HAVE BEEN FULLY CLOSED INITIALLY. FOLLOW-UP IMAGING PERFORMED (B)(6) 2026, CONFIRMED THAT THE 44 MM GCA REMAINS IN PLACE.

  Patient problems: Foreign Body Embolism

  MAUDE report 24913759 ↗
• InjuryApr 14, 2026Patient Device Interaction Problem

  IT WAS REPORTED; THE PHYSICIAN IMPLANTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER IN (B)(6) 2025. THE PATIENT HAD AN MRI CONFIRMED ACUTE INFARCT ON (B)(6) 2026. THROMBUS WAS NOTED ON THE RIGHT AND LEFT EYELETS OF THE DEVICE. THE PATIENT WAS TESTED WITH HEPARIN INFUSION THEN TRANSITIONED TO COUMADIN. BLOOD CULTURES AND NICKEL ALLERGY WERE ALL NEGATIVE.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 24876201 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT HAD PAROXYSMAL ATRIAL FIBRILLATION, WHICH WAS TREATED WITH ELIQUIS.

  Patient problems: Atrial Fibrillation

  MAUDE report 24867120 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT HAD ATRIAL FIBRILLATION, WHICH WAS TREATED WITH METOPROLOL TARTRATE AND A 14 DAY HEART RYTHUM MONITOR WAS PLACED.

  Patient problems: Atrial Fibrillation

  MAUDE report 24778914 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE. DURING THE PROCEDURE, THE DEVICE WAS DEPLOYED TOO DEEP AND CROSSED THE SEPTUM WITHOUT THE USE OF A GUIDEWIRE. THE PATIENT SUBSEQUENTLY EXPERIENCED CHEST PAIN, AND IMAGING IDENTIFIED A LARGE PERICARDIAL EFFUSION. THE DEVICE WAS REMOVED AND A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE FLUID. PATIENT WAS STABLE IN THE CARDIAC CARE UNIT.

  Patient problems: Pericardial Effusion

  MAUDE report 24768953 ↗
• InjuryApr 1, 2026Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE PHYSICIAN WAS IMPLANTING A GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A FLOPPY, ANEURYSMAL PATENT FORAMEN OVALE (PFO). THE PFO WAS CROSSED WITH A GUIDEWIRE, FIRST INTO THE LEFT ATRIAL APPENDAGE, THEN INTO THE LEFT UPPER PULMONARY VEIN. WHEN THE DEVICE WAS BEING DEPLOYED, IT WAS NOTED THAT THE CATHETER WAS IN A FENESTRATION, NOT THE PFO. THE CATHETER WAS REMOVED AND THE GUIDEWIRE CROSSED THROUGH THE PFO THIS TIME. THE GUIDEWIRE COULD NOT BE PARKED IN THE LEFT UPPER PULMONARY VEIN, SO IT WAS PLACED IN THE RIGHT UPPER PULMONARY VEIN. THE POOR INTRACARDIAC ECHOCARDIOGRAPHY(ICE) IMAGES, THE FLOPPY SEPTUM AND THE NOT IDEAL GUIDEWIRE PLACEMENT MADE VISUALIZING THE DEVICE VERY DIFFICULT. THE LEFT DISC WAS FIRST FORMED IN THE TUNNEL, SO IT WAS RECAPTURED AND DEPLOYED AGAIN. THIS TIME IT WAS FORMED OUTSIDE THE TUNNEL BUT STILL DID NOT LOOK RIGHT ON ICE. AT THIS POINT THE PATIENT BECAME UNRESPONSIVE FOR A SHORT TIME. THE PATIENT REGAINED CONSCIOUSNESS AND ANSWERED QUESTIONS BUT FELT LIKE THEY WERE GOING TO VOMIT. THE PATIENT THEN BECAME UNRESPONSIVE AGAIN. THE PATIENT WAS INTUBATED AND THE DEVICE AND CATHETER WERE REMOVED FROM THE PATIENT. A PERICARDIAL EFFUSION WAS NOTED

  Patient problems: Pericardial Effusion

  MAUDE report 24753505 ↗
• InjuryMar 10, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2020. ON (B)(6) 2021 THE PATIENT WAS NOTED TO HAVE PAROXYSMAL ATRIAL FIBRILLATION. THE PATIENT WAS SUBSEQUENTLY TREATED WITH BETA BLOCKERS AND METOPROLOL.

  Patient problems: Atrial Fibrillation

  MAUDE report 24563323 ↗
• InjuryMar 10, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION AND WAS STARTED ON ELIQUIS AND METOPROLOL. THE CONDITION IS NOTED AS ONGOING.

  Patient problems: Atrial Fibrillation

  MAUDE report 24562236 ↗

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