GORE CARDIOFORM ASD Occluder ASD27ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132636488), received between Dec 17, 2019 and Oct 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Expulsion” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO GORE A 27MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED ON (B)(6) 2022 TO TREAT AN ATRIAL SEPTAL DEFECT. IT WAS REPORTED THE PATIENT PRESENTED TO AN OUTSIDE EMERGENCY DEPARTMENT ON (B)(6) 2022 WITH FEVER/SEPSIS. THE PATIENT THEN PRESENTED TO THE IMPLANTING FACILITY ON (B)(6) 2022 WITH POSITIVE CULTURES AND NEGATIVE ECHOCARDIOGRAM. THE PATIENT WAS ADMITTED. THE FIRST ECHOCARDIOGRAM THAT SHOWED VEGETATION ON THE DEVICE WAS (B)(6) 2022. REPEAT ECHOCARDIOGRAM ON (B)(6) 2022, WHILE ON MULTIPLE ANTIBIOTICS AND ANTICOAGULANTS, SHOWED PROGRESSION OF THE VEGETATION. THE PATIENT HAD PERSISTENT POSITIVE CULTURES (MSSA) AND FEVER. THE DEVICE WAS EXPLANTED ON (B)(6) 2022. DURING THE OPEN CARDIOVASCULAR PROCEDURE, A LARGE VEGETATION COULD BE SEEN ON RIGHT ATRIAL DISC. THERE WAS ALSO A SMALL VEGETATION ON THE LEFT ATRIAL DISC WHEN REMOVED.

  Patient problems: Fever; Sepsis; Thrombosis/Thrombus

  MAUDE report 15666110 ↗
• InjuryDec 17, 2019Expulsion; Expulsion

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 27MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT ON (B)(6) 2019. THE DEFECT WAS NOT BALLOON SIZED. TRANSTHORACIC ECHOCARDIOGRAPHY ON (B)(6) 2019 SHOWED THE DEVICE HAD EMBOLIZED TO THE LEFT PULMONARY ARTERY. THE EMBOLIZED DEVICE WAS REMOVED BY SNARE IN A TRANSCATHETER PROCEDURE AND A 32MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED. THE PATIENT IS CURRENTLY STABLE AND DOING WELL.

  Patient problems: No Code Available

  MAUDE report 9480798 ↗