Amplatzer™ 9-ASD-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067019318), received between Aug 8, 2018 and Jun 13, 2019 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJun 13, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON AN UNKNOWN DATE, AN 18MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. FOLLOWING THE PROCEDURE, ON (B)(6) 2019, THE DEVICE WAS REPORTED TO HAVE EMBOLIZED. ON (B)(6) 2019, THE DEVICE WAS REMOVED FROM THE PATIENT PERCUTANEOUSLY BY SNARING AND RE-SHEATHING. THE DEFECT WAS BALLOON-SIZED TO 18MM USING A 30MM PTS SIZING BALLOON (LOT NUMBER: UNKNOWN) AND THE PHYSICIAN ATTEMPTED CLOSURE WITH A 22MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6821072) AND 26MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 5562243). BOTH DEVICES WERE REPORTED TO BE MIS-SIZED. OF NOTE, THE 26MM AMPLATZER SEPTAL OCCLUDER WAS IMPINGING ON THE MITRAL VALVE. THE PHYSICIAN ELECTED TO ABANDONED THE PROCEDURE AND SURGICAL CLOSURE IS PLANNED FOR A FUTURE TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8697308 ↗
• InjuryJan 31, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2017, A 26MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN A PATIENT WITH A LARGE ASD MEASURING 22-24MM ON TEE. TEE SHOWED THE DEVICE WAS IN EXCELLENT POSITION AND NO PERICARDIAL EFFUSION WAS OBSERVED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. TEE FROM TWO FOLLOW-UP VISITS HAD NO SIGNIFICANT FINDINGS. ON (B)(6) 2018, THE PATIENT COLLAPSED AND WAS TRANSPORTED TO THE EMERGENCY ROOM. THE PATIENT HAD BEEN COMPLAINING OF CHEST PAIN ONE WEEK PRIOR. AT THE ER, ECHOCARDIOGRAM SHOWED A LARGE PERICARDIAL EFFUSION AND EROSION RESULTING IN ACUTE HEMOPERICARDIUM AND HYPOTENSION. AN EMERGENT PERICARDIOCENTESIS WAS PERFORMED WHERE 300CC OF BLOOD WAS DRAINED. FOLLOWING DRAINAGE, THE PATIENT'S BLOOD PRESSURE INCREASED FROM 70/40 TO 130/80 AND THEIR HEART RATE DECREASED. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WHERE A 6MM BY 3MM PERFORATION WAS OBSERVED IN THE DOME OF THE LEFT ATRIUM AND A 2 BY 3MM PERFORATION WAS SEEN IN THE NON-CORONARY SINUS. THE DEVICE WAS REMOVED AND A PERICARDIAL PATCH CLOSURE WAS PERFORMED. DURING RECOVERY, THE PATIENT WAS TAKEN BACK TO THE OR TO REMOVE A LARGE CLOT IN THE PERICARDIUM COMPRESSING THE LEFT ATRIUM. THE PATIENT WAS REPORTED TO BE RECOVERED W

  Patient problems: Erosion; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 8292381 ↗
• DeathAug 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, A 26 MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. AFTER IMPLANT, THE PATIENT COMPLAINED OF CHEST PAIN AND ECHOCARDIOGRAM SHOWED A SMALL TO MODERATE PERICARDIAL EFFUSION WITH THE DEVICE STILL IN GOOD POSITION. BEDSIDE PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS INTUBATED. THE PERICARDIOCENTESIS REVEALED FRANK BLOOD CLOTS AND THE PATIENT QUICKLY DECOMPENSATE AND CPR WAS ADMINISTRATED. THE PATIENT REQUIRED CPR WHILE TRANSFERRED TO THE OR WHERE AN EMERGENCY STERNOTOMY WAS PERFORMED. THE PATIENT WAS PLACED ON CARDIAC BYPASS, AND CARDIAC TAMPONADE PHYSIOLOGY WAS NOTED. IN THE OPERATING ROOM (OR), TWO HOLES WERE DEMONSTRATED IN THE AORTIC ROOT AND ROOF OF THE RIGHT ATRIUM. BOTH WERE SURGICALLY CLOSED. DUE TO THE CLINICAL CONDITION THE PATIENT WAS TRANSFERRED TO A REGIONAL MEDICAL CENTER FOR ECMO. UPON ARRIVAL AT THE SECOND HOSPITAL ON (B)(6) 2018, THE PATIENT WAS TAKEN TO THE OR WHERE THE DEVICE WAS NOTED TO BE IN GOOD POSITION HOWEVER THE DISK HAD LEFT AN INDENTATION IN THE ATRIA AND HAD RUBBED THROUGH THE ROOF OF THE ATRIA AT THE JUNCTION OF THE AORTIC ROOF AND RIGHT ATRIA. THE DEVICE WAS REMOVED. THE PATIENT¿S HEART SLOWLY RECOVERED WITH THE USE OF ECMO, HOWEVER

  Patient problems: Cardiac Tamponade; Erosion; Pericardial Effusion

  MAUDE report 7780735 ↗
• InjuryAug 8, 2018Unintended Movement; Unintended Movement

  A 26 MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED PER THE IFU WITH THE DEFECT BALLOON-SIZED TO STOP FLOW. LATER THAT EVENING, THE ASO WAS FOUND TO HAVE EMBOLIZED TO THE LEFT VENTRICLE. ON (B)(6) 2018, THE ASO WAS SURGICALLY REMOVED AND THE DEFECT WAS CLOSED. PER REPORT, THE SEPTUM WAS NOTED TO BE FLOPPY AND THE PATIENT ANATOMY INCLUDED A DEFICIENT RIM. POST SURGICAL PROCEDURE, THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7764916 ↗