AMPLATZER™ 9-ITV12F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811806010885), received between Sep 11, 2018 and Oct 29, 2025 — classified as 3 deaths, 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING USE, AFTER INSERTION INTO THE PATIENT, IT WAS OBSERVED THAT THE SHEATHS EXTENSION WAS "EITHER CRACKED OR SPLIT", RESULTING IN "A HUGE LEAKAGE" OF SALINE IN A CONTINUOUS DRIP FROM THE PROXIMAL SIDE OF THE SHEATH. THE DEVICE WAS EXCHANGED FOR A NEW 12F AMPLATZER TORQVUE DELIVERY SYSTEM. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411345 ↗
• MalfunctionSep 19, 2025Premature Separation; Premature Separation

  IT WAS REPORTED ON (B)(6) 2025 A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE USED DURING THE PROCEDURE. THE ASD WAS MEASURED AT 26MM. THE DEVICES WERE PREPARED PER INSTRUCTIONS FOR USE (IFU). THE CABLE CONNECTION WAS CHECKED DURING DEVICE PREPARATION AND PRIOR TO DEPLOYMENT. DURING THE PROCEDURE THE OCCLUDER PREMATURELY DISCONNECTED FROM THE DELIVERY CABLE WHEN THE CABLE WAS GENTLY PULLED BACK TO THE DELIVERY SYSTEM. THE OCCLUDER CAUSED A PARTIAL BLOCKAGE OF BLOOD FLOW IN THE LEFT PULMONARY ARTERY. AN ATTEMPT WAS MADE TO SNARE THE OCCLUDER BUT WAS UNSUCCESSFUL. THE PATIENT UNDERWENT SURGERY TO REMOVE THE DEVICE AND CLOSE THE ASD. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097354 ↗
• DeathJul 19, 2022Premature Separation; Premature Separation

  THIS EVENT IS BEING REPORTED FOR DEATH DUE TO THE PREMATURE SEPARATION OF THE DELIVERY SYSTEM FROM THE OCCLUDER. IT WAS REPORTED A 30 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE USING AN AMPLATZER TORQVUE DELIVERY SYSTEM ON (B)(6) 2022. THERE WERE NO ISSUES DURING DEVICE PREPARATION. DURING PROCEDURE, THE DEVICE PRESENTED WITH A BULGING SHAPE AND WHEN THE USER ATTEMPTED TO REMOVE THE DEVICE, THE DEVICE DISCONNECTED FROM THE CABLE, EMBOLIZING INTO THE PATIENT'S LEFT ATRIUM. THE DEVICE DID NOT OCCLUDE THE PATIENT'S BLOOD FLOW. THE PATIENT IMMEDIATELY BECAME UNSTABLE. THE PATIENT WENT INTO CARDIAC ARREST WHILE WAITING TO TRANSFER TO CARDIAC SURGERY. DEFIBRILLATION EFFORTS WERE MADE AND WERE UNSUCCESSFUL AND THE PATIENT PASSED AWAY. RELATED MANUFACTURING REFERENCE NUMBER 2135147-2022-00252-00 (EMBOLIZATION OF DEVICE AND BULGING SHAPE)

  Patient problems: Cardiac Arrest

  MAUDE report 15049657 ↗
• DeathNov 8, 2021Biocompatibility; No Apparent Adverse Event; Biocompatibility; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2021, A 22MM AMPLATZER P.I. MUSCULAR VENTRICULAR SEPTAL DEFECTS (VSD) OCCLUDER WAS SELECTED FOR IMPLANT, IN A PATIENT WHO HAD SUFFERED A HEART ATTACK A FEW DAYS PRIOR TO THE PROCEDURE AND HAD TO BE REVIVED. IT WAS NOTED THAT THE PATIENT HAD TWO VSDS AND CLOSING THE TWO VSDS QUICKLY WAS THE ONLY POSSIBILITY TO SAVE THE PATIENT. DURING THE PROCEDURE, THE FIRST VSD OCCLUDER WAS IMPLANTED. DURING THE ATTEMPT TO CLOSE THE SECOND VSD, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHILE THE OPERATOR TRIED TO CROSS THE SECOND VSD WITH A NON-ABBOTT (COOK MEDICAL) STIFF GUIDEWIRE AND A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. HEART MASSAGES WERE PERFORMED AND ATTEMPTS WERE MADE TO DRAIN THE EFFUSION HOWEVER, THE PATIENT DIED DURING PROCEDURE. IT WAS REPORTED THAT THE CAUSE OF THE PERICARDIAL EFFUSION WAS THE NON-ABBOTT (COOK) STIFF GUIDEWIRE. ONLY ONE AMPLATZER P.I. MUSCULAR VSD OCCLUDER WAS IMPLANTED. OPERATIVE NOTES WERE REQUESTED BUT ARE NOT AVAILABLE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pericardial Effusion

  MAUDE report 12770516 ↗
• DeathSep 11, 2018Material Perforation; Material Perforation

  THIS CASE WAS A "SURGICAL TURN DOWN" DUE TO THE CONDITION OF THE PATIENT. DURING A PROCEDURE TO CLOSE A POST INFARCT VENTRICULAR SEPTAL DEFECT (VSD), THE DEFECT WAS CROSSED USING THE STANDARD METHOD LEFT TO RIGHT TECHNIQUE TO CREATE AN AV LOOP. THE DEVICE ACCESS WAS VIA TRANSJUGULAR APPROACH. THE 12F TORQVUE 45 DELIVERY SYSTEM (DTV45) WAS INTRODUCED AND CROSSED THROUGH THE DEFECT TO THE RIGHT VENTRICLE AND THEN TO THE LEFT VENTRICLE OVER THE GUIDEWIRE. A 24 MM AMPLATZER P.I. MUSCULAR VSD OCCLUDER (PIMUSCVSD) (LOT: 6351799) WAS SELECTED AND DEPLOYED IN AN INFERIOR APICAL DEFECT. THE LEFT VENTRICULAR DISC PROLAPSED THROUGH THE DEFECT WITHOUT APPLYING TENSION AS THE DEFECT WAS LARGE SO THE PIMUSCVSD DEVICE WAS REMOVED AND A 30 MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS THEN ATTEMPTED TO BE USED OFF-LABEL. THE DTV45 SHEATH WAS STILL IN THE RIGHT VENTRICLE, HOWEVER; THE GUIDEWIRE WAS NO LONGER ACROSS THE DEFECT DUE TO BREAKING THE CIRCUIT TO ALLOW DEPLOYMENT OF THE 24MM PIMUSCVSD. THE USER DECIDED THAT DUE TO THE SIZE OF THE DEFECT THEY WOULD TRY AND CROSS FROM THE RIGHT VENTRICLE TO THE LEFT VENTRICLE USING A PIGTAIL CATHETER AND GUIDEWIRE. THE DEFECT WAS CROSSED AND THE PIGTAIL CATHETER W

  Patient problems: Death; Pericardial Effusion

  MAUDE report 7863949 ↗