GORE CARDIOFORM ASD OccluderRecalls & reported problems across all models

We found 5 models of GORE CARDIOFORM ASD Occluder by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 114 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2019 and Sep 16, 2026 — classified as 111 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (36 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 ASD 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. Sep 21, 2022Open, Classified

   Due to manufacturing records (Release Test Results) indicating "Failed".

   Z-0136-2023 · Root cause: Employee error · names 2 of these models · Recall details · FDA record ↗

Most reported GORE CARDIOFORM ASD Occluder problems

GORE CARDIOFORM ASD Occluder models

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

• GORE CARDIOFORM ASD Occluder ASD37A

  Transcatheter Septal Occluder
  1 recall42 reports
• GORE CARDIOFORM ASD Occluder ASD44A

  Transcatheter Septal Occluder
  1 recall24 reports
• GORE CARDIOFORM ASD Occluder ASD32A

  Transcatheter Septal Occluder
  23 reports
• GORE CARDIOFORM ASD Occluder ASD48A

  Transcatheter Septal Occluder
  23 reports
• GORE CARDIOFORM ASD Occluder ASD27A

  Transcatheter Septal Occluder
  2 reports

Recent GORE CARDIOFORM ASD Occluder adverse event reports

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

• InjurySep 16, 2026Positioning Problem; Migration

  Patient problems: Foreign Body Embolism

  MAUDE report 50793720 ↗
• InjurySep 16, 2026Positioning Problem; Migration

  Patient problems: Foreign Body Embolism

  MAUDE report 50793187 ↗
• InjurySep 16, 2026Device Dislodged or Dislocated; Migration

  It was reported; the physician implanted a 37mm GORE® CARDIOFORM ASD Occluder to close a 19-21mm Atrial Septal Defect with a deficient aortic rim. As the patient was being extabated, the patient started coughing and the device was noted to have embolized to the Pulmonary Artery. The device was removed with a snare and a new 44mm GORE® CARDIOFORM ASD Occluder was implanted. The patient was doing well following the procedure.

  Patient problems: Foreign Body Embolism

  MAUDE report 50792997 ↗
• MalfunctionSep 3, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589761 ↗
• InjuryAug 20, 2026Device Slipped; Material Split, Cut or Torn

  It was reported the physician selected a 37mm GORE® CARDIOFORM ASD Occluder to treat an atrial septal defect. The occluder was deployed and locked. The occluder then prolapsed and while attempting to retrieve the device the retrieval cord broke. The occluder embolized to the right pulmonary artery. A preliminary attempt to snare the device was unsuccessful and the occluder was ultimately retrieved with forceps and a 24Fr. catheter. A 48mm GORE® CARDIOFORM® ASD Occluder was implanted with no adverse effects. The patient was doing well following the procedure.

  Patient problems: Foreign Body Embolism

  MAUDE report 50358617 ↗
• InjuryMay 6, 2026Difficult or Delayed Positioning

  IT WAS REPORTED; THE PHYSICIAN WAS IMPLANTING A 48MM GORE® CARDIOFORM ASD OCCLUDER, TO CLOSE AN ATRIAL SEPTAL DEFECT. THE ASD HAD A BALD AORTIC RIM. THE DEFECT BALLOON SIZED TO 23-24 MM. THE PHYSICIAN CHOSE TO TRY THE 48MM DEVICE FIRST BECAUSE OF THE BALD RIM. THE DEVICE WAS ATTEMPTED WITH THE USE OF A MULLINS SHEATH. AFTER MULTIPLE ATTEMPTS WITH THE DEVICE SLIPPING OFF THE AORTIC RIM, THE PHYSICIAN TRIED TO USE A 44 MM GORE® CARDIOFORM ASD OCCLUDER. THE 44MM DEVICE ALSO PROLAPSED THROUGH THE BALD AORTIC RIM. THE NEXT STEP WAS TO CURVE THE CATHETER OUTSIDE THE BODY AND TRY AGAIN. BEFORE THE DEVICE WAS INSERTED AGAIN, A PERICARDIAL EFFUSION WAS NOTED, AND THE PATIENT WAS TREATED WITH A PERICARDIOCENTESIS. THE EFFUSION APPEARED TO COME FROM THE FREE WALL OF THE LEFT ATRIUM. AN AMPLATZER DEVICE WAS IMPLANTED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 25098593 ↗
• InjuryMay 5, 2026Expulsion

  IT WAS REPORTED THE PHYSICIAN SELECTED A 48MM GORE® CARDIOFORM ASD OCCLUDER (S/N: (B)(6)) TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). AFTER DEPLOYMENT AND LOCKING, THE DEVICE PROLAPSED. THE DEVICE WAS REMOVED, AND THE PHYSICIAN SELECTED A SECOND 48MM GORE® CARDIOFORM ASD OCCLUDER (S/N:(B)(6)). THE SECOND DEVICE WAS SUCCESSFULLY DEPLOYED AND LOCKED; HOWEVER, LATER IN THE EVENING ON (B)(6), 2026, THE DEVICE EMBOLIZED. THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) FOR SURGICAL REMOVAL OF THE DEVICE AND SURGICAL CLOSURE OF THE ASD. PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 25083312 ↗
• InjuryApr 17, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT AN 11-YEAR-OLD FEMALE UNDERWENT ATRIAL SEPTAL DEFECT CLOSURE ON (B)(6), 2025, USING A 32 MM GORE® CARDIOFORM ASD OCCLUDER. POSTOPERATIVELY, THE PATIENT BEGAN EXPERIENCING DIZZINESS AND NEAR-SYNCOPE, WHICH HAVE PROGRESSIVELY INCREASED IN FREQUENCY. A FIRST-DEGREE ATRIOVENTRICULAR (AV) BLOCK WAS NOTED POST-PROCEDURE BUT HAS SINCE RESOLVED. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED AND EVALUATED FOR MRI WITHOUT CONTRAST. CONCERNS REGARDING MRI SAFETY, INCLUDING POTENTIAL DEVICE MOVEMENT AND/OR HEATING, WERE RAISED BY THE PATIENT¿S GUARDIANS. AS A RESULT, A DECISION WAS MADE TO FOREGO MRI EVALUATION ON (B)(6), 2026. THE FIRST-DEGREE AV BLOCK WAS TREATED WITH A SHORT COURSE OF STEROIDS.

  Patient problems: Arrhythmia

  MAUDE report 24915143 ↗
• InjuryApr 14, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED; THE PHYSICIAN SELECTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEVICE CROSSED THE DEFECT ON A GUIDEWIRE AND WAS PLACED IN THE DEFECT WITH MINIMAL SHUNT. AFTER LOCKING, THE SHUNT WAS MORE PRONOUNCED, AND THE PHYSICIAN DECIDED TO REMOVE THE DEVICE FOR UPSIZING. THE PHYSICIAN FELT TENSION WHILE TRYING TO RECAPTURE THE DEVICE WITH THE RETRIEVAL CORD. THE DEVICE WAS PULLED DOWN TO THE INFERIOR VENA CAVA TO AID IN RECAPTURE. AS MORE PRESSURE WAS APPLIED, THE RETRIEVAL CORD BROKE AND THE DEVICE EMBOLIZED. THE EMBOLIZED OCCLUDER WAS REMOVED WITH A SNARE FROM THE RIGHT ILIAC VEIN. ON INSPECTION, THE TIP OF THE DELIVERY CATHETER WAS KINKED AT THE GUIDEWIRE PORT. A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED WITH NO ISSUES. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 24872382 ↗
• InjuryMar 30, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). THE ASD WAS CROSSED WITH A GUIDEWIRE AND BALLOON SIZED TO APPROXIMATELY 25MM. THE DEVICE WAS ADVANCED AND DEPLOYED BUT KEPT SLIPPING OFF THE DEFECT. ON THE THIRD TRY THE DEVICE LOOKED STABLE AND WAS LOCKED AND RELEASED. ON ECHOCARDIOGRAPHY, A PERICARDIAL EFFUSION WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE, AND THE EFFUSION HAD STOPPED. THE DEVICE WAS CHECKED AGAIN, BUT IT HAD SLIPPED OFF TWO OF THE RIMS. THE PHYSICIAN ELECTED TO REMOVE THE DEVICE OFF THE SEPTUM USING A SNARE AND BIOTOMES THROUGH THE 16FR SHEATH. THE PATIENT WILL HAVE SURGICAL CLOSURE OF THE ASD AT A LATER DATE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 24716085 ↗
• InjuryFeb 26, 2026Difficult to Remove

  IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED TO IMPLANT A 32 MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). THE DEVICE WAS DETERMINED TO BE TOO SMALL FOR THE DEFECT AND WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 37 MM GORE® CARDIOFORM ASD OCCLUDER. DURING THIS ATTEMPT, A RESIDUAL SHUNT WAS OBSERVED. AS THE PHYSICIAN ATTEMPTED TO UNLOCK THE DEVICE, THE DEVICE PULLED THROUGH THE SEPTUM. IT WAS ALSO NOTED THAT THE DELIVERY CATHETER BECAME KINKED DURING THE UNLOCKING ATTEMPT. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS THEN INSERTED TO ASSIST WITH CAPTURING THE 37 MM DEVICE. WHILE ATTEMPTING RETRIEVAL, THE BIOTOME HANDLE BROKE WHEN THE OCCLUDER DEVICE WAS HALFWAY INTO A 14 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WITH THE BIOTOME STILL ATTACHED. THE PHYSICIAN RELEASED THE OCCLUDER DEVICE, EXCHANGED THE CARDIOFORM DELIVERY SYSTEM, PLACED ANOTHER GORE® DRYSEAL FLEX INTRODUCER SHEATH, AND ATTEMPTED RETRIEVAL USING AN ONO SYSTEM. WHEN THIS WAS UNSUCCESSFUL, THE OCCLUDER DEVICE WAS ULTIMATELY REMOVED USING LARGER FORCEPS (ALLIGATOR CLIP). AN ANGIOGRAM REVEALED BLEEDING AND DAMAGE TO THE INFERIOR VENA CAVA (IVC). A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462170 ↗
• InjuryJan 26, 2026Positioning Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 37MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT A THICK SECUNDUM ATRIAL SEPTAL DEFECT (ASD) STATIC SIZED 18.2MM. THE DEFECT WAS NOT BALLOON SIZED. A ROSEN J-TIPPED GUIDEWIRE AND 14 FR SHEATH WERE USED TO CROSS THE DEFECT. THE OCCLUDER WAS THEN ADVANCED AND MULTIPLE DEPLOYMENT ATTEMPTS WERE MADE BUT THE OCCLUDER DID NOT SUCCESSFULLY CLOSE THE DEFECT AND A SHUNT REMAINED. THE 37MM DEVICE WAS REMOVED AND THE PHYSICIAN SELECTED A 44MM GORE® CARDIOFORM ASD OCCLUDER. FOLLOWING MULTIPLE ATTEMPTS OF DEPLOYING AND REPOSITIONING, A PERICARDIAL EFFUSION WAS NOTED (APPROXIMATELY 2 HOURS INTO THE PROCEDURE) AND THE DEVICE WAS REMOVED. A PERICARDIOCENTESIS WAS PERFORMED. ONE LITER OF FLUID WAS TAPPED, AND PATIENT WAS WATCHED FOR 20 MINUTES BEFORE BEING SENT TO SURGERY. THE PATIENT WAS STABLE BEFORE BEING TRANSFERRED TO THE OR. THE PHYSICIAN WAS UNSURE OF WHAT CAUSED THE PERICARDIAL EFFUSION BUT DID NOT THINK IT WAS OCCLUDER RELATED.

  Patient problems: Pericardial Effusion

  MAUDE report 24182790 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS REVIEWED FOLLOWING THE SURGERY AND IT APPEARED THAT PART OF THE DEVICE SHIFTED INTO THE LEFT ATRIUM AND A 3-4MM COLOR JET WAS NOTED. THE PHYSICIAN DECIDED TO LEAVE THE DEVICE IMPLANTED AND CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Pericardial Effusion

  MAUDE report 23878310 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44 MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT MEASURING APPROXIMATELY 25 MM, WITH A DEFICIENT AORTIC RIM AND A SMALL POSTERIOR RIM. THE PHYSICIAN ATTEMPTED MULTIPLE DEPLOYMENTS WITH THE SAME DEVICE; HOWEVER, AFTER SEVERAL LOADING AND RELOADING CYCLES, THE DEVICE BECAME INCREASINGLY DIFFICULT TO LOAD. THE DECISION WAS MADE TO DISCONTINUE USE OF THAT DEVICE AND PROCEED WITH A NEW 44 MM OCCLUDER. THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED WITH ASSISTANCE FROM THE SENIOR PARTNER. FOLLOWING IMPLANTATION, THE PHYSICIAN REPORTED THAT THROMBUS WAS OBSERVED ON THE DEVICE DURING A FOLLOW-UP CALL ON FRIDAY EVENING. THE PATIENT SUBSEQUENTLY DEVELOPED A MILD FEVER AROUND TUESDAY EVENING AND WAS EVALUATED AT AN ADULT EMERGENCY DEPARTMENT BEFORE BEING TRANSFERRED TO A CHILDREN¿S HOSPITAL. AN ECHOCARDIOGRAM REVEALED THROMBUS/VEGETATION, AND ANTIBIOTICS WERE INITIATED. THE PATIENT WAS ADMITTED TO THE ICU FOR MONITORING AND CONTINUED ANTIBIOTIC THERAPY. BLOOD CULTURES SHOWED NO GROWTH, AND A REPEAT ECHOCARDIOGRAM INDICATED RESOLUTION OF THE THROMBUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 23830298 ↗
• InjuryDec 17, 2025Migration; Migration

  IT WAS REPORTED THAT A 37 MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT (ASD) WITH A SEVERELY DEFICIENT RIM. FOLLOWING THE PROCEDURE, A POSTOPERATIVE X-RAY REVEALED THAT THE DEVICE HAD EMBOLIZED. THE PATIENT WAS SUBSEQUENTLY TAKEN TO SURGERY FOR DEVICE RETRIEVAL AND OPEN REPAIR OF THE ASD. THE PHYSICIAN BELIEVES THE EMBOLIZATION OCCURRED DUE TO THE PATIENT¿S ANATOMY. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Foreign Body Embolism

  MAUDE report 23829470 ↗

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