Amplatzer™ 9-VSD-MUSC-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811806011806), received between Oct 9, 2019 and Jan 16, 2026 — classified as 1 death, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (6 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101602 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 23 AUGUST 2024, AN 8MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT TO CLOSE A VENTRICULAR SEPTAL DEFECT (VSD) USING A NON-ABBOTT DELIVERY SYSTEM. THE VSD WAS DESCRIBED AS A GERBODE DEFECT. DURING DEPLOYMENT OF THE DEVICE, THE PATIENT DEVELOPED AN ATRIOVENTRICULAR (AV) HEART BLOCK. A TEMPORARY PACEMAKER WAS INSERTED. THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE HEART BLOCK RESOLVED ON THE SAME DAY. THE PATIENT STATUS WAS REPORTED AS STABLE. THE PATIENT WAS DISCHARGED WITH A HEART MONITOR.

  Patient problems: Heart Block

  MAUDE report 20242348 ↗
• InjuryJan 30, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT WAS NOTED THAT POST-IMPLANT THE OCCLUDER EMBOLIZED INTO THE PATIENT'S PULMONARY ARTERY. THE DECISION WAS MADE TO ATTEMPT A PERCUTANEOUS EXTRACTION OF THE OCCLUDER, BUT WAS UNSUCCESSFUL. THE PATIENT WAS THEN SENT TO SURGERY TO HAVE THE 8MM AMPLATZER MUSCULAR (VSD) OCCLUDER EXPLANTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT A 6F AMPLATZER TORQVUE DELIVERY SYSTEM WAS USED DURING THE IMPLANT PROCEDURE. THE 8MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS SIZED USING ANGIOGRAPHY AND TRANSTHORACIC ECHOCARDIOGRAPHY. THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS NOTED THAT THE 8MM AMPLATZER MUSCULAR (VSD) OCCLUDER EMBOLIZATION WAS CONFIRMED USING TRANSTHORACIC ECHOCARDIOGRAPHY. IT WAS ALSO NOTED THAT THE OCCLUDER COMPLETELY DISLODGED AND EMBOLIZED INTO THE PATIENT'S RIGHT PULMONARY ARTERY. THE PATIENT DID NOT SUFFER ANY CLINICAL SYMPTOMS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269116 ↗
• InjurySep 29, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 18MM AMPLATZER POST-INFARCT MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED THAT DURING PROCEDURE THE OCCLUDER EMBOLIZED AFTER BEING FULLY DEPLOYED. THE DECISION WAS MADE TO SEND THE PATIENT TO SURGERY TO EXPLANT THE EMBOLIZED OCCLUDER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503592 ↗
• InjuryJul 22, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 8MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. REPORTEDLY, 5 MINUTES POST IMPLANTATION THE DEVICE EMBOLIZED. THE DECISION WAS MADE TO RETRIEVE THE AMPLATZER VSD OCCLUDER PERCUTANEOUSLY WITH A SNARE CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15086568 ↗
• InjuryJul 12, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 10MM AMPLATZER VSD MUSCULAR OCCLUDER AND 12MM AMPLATZER VSD MUSCULAR OCCLUDER WERE SELECTED FROM AN IMPLANT ON 14 JUNE 2022. THE DEFECT WAS SIZED USING ECHOCARDIOGRAM. DURING THE PROCEDURE, IT WAS REPORTED THAT 10MM AND 12MM AMPLATZER VSD OCCLUDER SHIFTED WITHIN THE INTENDED IMPLANT SITE TOWARDS THE LEFT VENTRICLE. IT IS UNKNOWN WHAT CAUSED THE DEVICES TO SHIFT IN POSITION. PATIENT WAS SENT TO EMERGENT OPEN HEART SURGERY TO RETRIEVE THE OCCLUDER. NO REPLACEMENT DEVICE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991568 ↗
• DeathApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS BEING CONSERVATIVELY REPORTED FOR DEATH AS THE CAUSE OF DEATH POST PROCEDURE IS UNKNOWN. IT WAS REPORTED THAT AN 8MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS CHOSEN FOR PROCEDURE ON (B)(6) 2022 FOR CLOSURE OF A VENTRICULAR PSEUDOANEURYSM. DURING THE PROCEDURE THE DEVICE WAS INITIALLY DEPLOYED FOR PLACEMENT HOWEVER IT WAS DETERMINED TO BE TOO SMALL. THE DEVICE WAS REMOVED PRIOR TO BEING RELEASED FROM THE CABLE. DURING PREPARATION OF THE REPLACEMENT DEVICE, A 10MM AMPLATZER MUSCULAR VSD OCCLUDER, THE PATIENT BECAME HYPOTENSIVE AND HEMODYNAMICALLY UNSTABLE REQUIRING CHEST COMPRESSIONS. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED AFTER 31 MINUTES OF CARDIOPULMONARY RESUSCITATION (CPR). DURING CHEST COMPRESSIONS, THE 10MM AMPLATZER VSD OCCLUDER WAS SUCCESSFULLY IMPLANTED. AN INTRA-AORTIC BALLOON PUMP (IABP) AND A LEFT VENTRICULAR ASSIST DEVICE (LVAD) (IMPELLA) WERE PLACED. THE PATIENT WAS GIVEN EPINEPHRINE AND PRESSOR. THE PATIENT'S CONDITION DID EVENTUALLY STABILIZE, THEIR BLOOD PRESSURE AND CARDIAC FUNCTION HAD IMPROVED WITH THE INTERVENTIONS. THE PROCEDURE WAS COMPLETED WITH THE PATIENT IN STABLE CONDITION. LATER THAT SAME DAY, POST PROC

  Patient problems: Cardiac Arrest

  MAUDE report 14191650 ↗
• InjuryDec 29, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2021, AN 8 MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR PROCEDURE OF CLOSING THREE PARAVALVULAR LEAKS OF A MECHANICAL MITRAL VALVE (UNKNOWN MANUFACTURER). THE 8 MM OCCLUDER WAS RELEASED IN THE FIRST DEFECT. NEXT, A 10 MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SUCCESSFULLY IMPLANTED IN ANOTHER LEAK USING THE 6 F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE RELEASE OF THE 10 MM OCCLUDER, IT WAS DISCOVERED THAT THE 8 MM OCCLUDER HAD DISLODGED WITHIN THE HEART DUE TO BEING TOO SMALL. THE 8 MM OCCLUDER WAS SUCCESSFULLY SNARED FROM THE PATIENT, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AFTER RETRIEVING THE 8 MM OCCLUDER. A 12 MM AMPLATZER MUSCULAR VSD OCCLUDER WAS OPENED AND PREPARED FOR THE THIRD DEFECT, BUT IT WAS NEVER IMPLANTED INTO THE PATIENT. THE DECISION WAS MADE TO SEND THE PATIENT FOR SURGICAL REVISION OF THE MITRAL VALVE AT A LATER DATE. THE DOCTOR DID NOT FEEL THERE WAS A SIGNIFICANT DELAY DESPITE HAVING TO SNARE THE DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PHYSICIAN KNEW THAT THIS CASE WAS GOING TO BE DIFFICULT AND THAT THERE WAS A CHANCE THAT IT WOULD NOT BE SUCCESSFUL, BUT THIS PROCEDURE

  Patient problems: Failure of Implant

  MAUDE report 13111754 ↗
• MalfunctionApr 28, 2021Material Deformation; Material Deformation

  UPDATED ED: IT WAS REPORTED ON (B)(6), 2021 AN 8 MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR PROCEDURE. DURING DEPLOYMENT, THE LEFT DISC DID NOT FULLY CONFORM TO THE SEPTUM, IT REMAINED IN A "ROUND" SHAPE. THE PHYSICIAN RETRIEVED THE DEVICE AND ATTEMPTED TO REDEPLOY BUT THE DEFORMATION REMAINED. THE DEVICE WAS RETRIEVED AND EXCHANGED WITH A LARGER AMPLATZER MUSCULAR VSD OCCLUDER, A 10 MM. THE PROCEDURE WAS SUCCESSFUL AND NO CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739631 ↗
• InjuryOct 9, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2019, AN 8MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. AFTER A LIGHT PUSH PULL TEST, THE DEVICE WAS SUCCESSFULLY RELEASED. AFTER A FEW HOURS THE DEVICE EMBOLIZED TO THE PULMONARY ARTERY. THE DEVICE WAS ATTEMPTED TO BE SNARED UNSUCCESSFULLY AND MIGRATED TO THE RIGHT PULMONARY ARTERY (RPA). THE DECISION WAS MADE TO SURGICALLY REMOVE THE DEVICE. THE PATIENT WAS TRANSFERRED TO SURGERY WHERE THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PDA SURGICALLY CLOSED. THE USER BELIEVES THE LARGE PULSATILE DUCT CONTRIBUTED TO THE EMBOLIZATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9173071 ↗