AMPLATZER™ 9-ITV10F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00811806010878), received between Sep 7, 2018 and Apr 28, 2025 — classified as 3 deaths, 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathApr 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, AN UNKNOWN SIZE OCCLUDER WAS CHOSEN FOR A POSTINFARCT VENTRICULAR SEPTAL DEFECT (PIVSD) CLOSURE PROCEDURE USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS WERE >250S AND HEPARIN WAS ADMINISTERED. WHEN THE DELIVERY SHEATH WAS BEING ADVANCED THROUGH THE DEFECT, A LARGE PERICARDIAL EFFUSION WAS SEEN AND IMMEDIATE LOSS OF OUTPUT. AN EMERGENCY PERICARDIAL DRAIN WAS INSERTED THROUGH A SUB XIPHOID APPROACH (FIRST PASS) AND CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED. A LARGE VOLUME OF BLOOD WAS ASPIRATED BUT THERE WAS NO IMPROVEMENT IN THE HEMODYNAMICS AND NO REDUCTION IN THE PERICARDIAL EFFUSION WAS NOTED. THERE WAS CONTINUED AND ONGOING BLEEDING AND NO WAY OF TREATING THAT. THEY MENTIONED IT WAS DUE TO MYOCARDIAL RUPTURE AND NO MECHANICAL PROBLEM THAT THEY COULD FIX, THE WHOLE TEAM AGREED THAT IT WAS APPROPRIATE TO STOP CPR. THE PATIENT WAS REPORTED PASSED AWAY. THE OCCLUDER WAS NOT OPENED AND USED. THE PHYSICIAN THOUGHT THE CAUSE OF DEATH WAS VENTRICULAR RUPTURE DURING A PERCUTANEOUS ATTEMPT TO CLOSE A POST INFARCT VENTRICULAR SEPTAL RUPTURE (VSD).

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion; Unspecified Tissue Injury

  MAUDE report 21919905 ↗
• MalfunctionApr 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 10F AMPLATZER TORQVUE 45/80 DELIVERY SYSTEM WAS PREPARED FOR A PROCEDURE. DURING PREPARATION BEFORE ENTERING PATIENT, THE DELIVERY SYSTEM WAS LEAKING. A REPLACEMENT NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814690 ↗
• InjuryOct 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER POST-INFARCT VSD OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT PRIOR TO PROCEDURE WAS MEDICALLY UNSTABLE WITH FRAGILE TISSUE AND POST-INFARCTION VENTRICULAR SEPTAL DEFECT. IN ADDITION, IT WAS REPORTED THERE WAS DIFFICULTY OBTAINING IMAGING AND PERICARDIAL EFFUSION IN THE LEFT VENTRICLE WAS PRESENT PRIOR TO THE PROCEDURE. THE DIMENSIONS OF THE EFFUSION WERE UNKNOWN. THE PHYSICIAN UPSIZED THE DEVICE DUE TO THE DEFECT SIZE AND THE FRAGILITY OF THE TISSUE. THE DEFECT WAS LOCATED CLOSE TO THE APEX ~1CM AND HAD A VERY ACUTE ANGLE. DURING DEPLOYMENT, THE LEFT VENTRICLE DISC APPEARED NORMAL WHEN DEPLOYED, BUT ONCE THE WAIST AND THE RIGHT VENTRICLE DISC WAS DEPLOYED, THE LEFT VENTRICLE DISC WAS VERY COMPRESSED/TWISTED ON FLUORO AND APPEARED WITH A COBRA DEFORMATION. THERE WAS INTERACTION WITH THE VENTRICULAR SEPTUM DURING DEPLOYMENT AND A KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND WAS REMOVED. IT WAS EXCHANGED FOR A NEW 20MM AMPLATZER POST-INFARCT VSD OCCLUDER AND A NEW 10F AMPLATZER TORQVUE DELIVERY SYSTEM

  Patient problems: Pericardial Effusion

  MAUDE report 20389572 ↗
• DeathMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 15 FEBRUARY 2024, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS CHOSEN FOR A HIGH RISK VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE POST MYOCARDIAL INFARCTION USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS IN A CARDIOGENIC SHOCK BEFORE THE BEGINNING OF THE PROCEDURE AND THE EJECTION FRACTION WAS LESS THAN 20%. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS WAS MORE THAN 250S AND HEPARIN WAS ADMINISTRATED. AN AMPLATZER GUIDEWIRE WAS USED TO INTRODUCE THE AMPLATZER TORQUE VIEW BY SUING THE ARTERIOVENOUS (AV) LOOP TECHNIC. DURING THE MANIPULATION OF DELIVERY SYSTEM INSIDE THE RIGHT VENTRICLE, THE PATIENTS HEALTH DECLINED. AN ECHOCARDIOGRAM (ECHO) HIGHLIGHTED A PERICARDIAL EFFUSION IN THE POSTERIOR PART OF THE HEART AND IT LEAD TO CARDIAC TAMPONADE. THE PATIENT HAD VERY LOW PRESSURE AND MASSIVE HEART COMPRESSION. A PERICARDIOCENTESIS WAS PERFORMED, AND THE OCCLUDER WAS IMPLANTED TO OPTIMIZE PATIENT STATUS BUT IT WAS NOT POSSIBLE TO STABILIZE THE PATIENT. THE PATIENT PASSED AWAY AT THE END OF THE PROCEDURE. THE CAUSE OF DEATH WAS CARDIAC ARREST. THE PHYSICIAN MENTIONED THE DEATH WAS NOT RELATED TO THE IMPLANT DEVICE AND IT WAS DUE TO THE RIS

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 18876010 ↗
• DeathJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT FOR DEATH IS BEING CONSERVATIVELY REPORTED. IT WAS REPORTED THAT ON (B)(6) 2021, AN 18 MM AMPLATZER P.I. MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT, HOWEVER WAS MIS-SIZED AS IT WAS NOT STABLE ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A 20 MM AMPLATZER P.I. MUSCULAR VSD OCCLUDER WAS THEN SELECTED WITH A 10F AMPLATZER TORQVUE DELIVERY SYSTEM (DS), HOWEVER, WHEN DEPLOYED, THE RIGHT DISC SHOWED A COBRA DEFORMATION. AFTER "SEVERAL RECAPTURES AND REDEPLOYMENTS," THE ISSUE PERSISTED. A NEW 20 MM AMPLATZER P.I. MUSCULAR VSD OCCLUDER WAS PREPARED TO BE EXCHANGED. HOWEVER, WHEN REMOVING THE FIRST 20 MM DEVICE WITH THE 10F AMPLATZER TORQVUE DS, ONE OF THE TRICUSPID CHORDAE WAS DAMAGED, RESULTING IN SIGNIFICANT TRICUSPID REGURGITATION. THE PATIENT WAS REFERRED TO SURGERY AND WAS TRANSFERRED TO THE OPERATING ROOM (OR) IN HEMODYNAMICALLY STABLE CONDITION. HOWEVER, THE PATIENT DEVELOPED HEART FAILURE AFTER EMERGENCY SURGERY AND FAILED INTERVENTION. THE PATIENT PASSED AWAY THE SAME DAY ((B)(6) 2021). THE USER DID NOT ALLEGE A MALFUNCTION WITH AN ABBOTT PRODUCT THAT LEAD TO THE PATIENT PASSING. THE USER DID NOT ALLEGE A RELATIONSHIP BETWEEN THE PATIENT PASSING AND AN ABBOTT PRODUCT. N

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 13169353 ↗
• InjuryJun 4, 2020Biocompatibility; Biocompatibility

  ON (B)(6) 2020, AN AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) MALE WITH A COMORBIDITY OF CEREBRAL INFARCTION. DURING THE IMPLANT PROCEDURE THE PATIENT WAS UNDER LOCAL ANESTHESIA AND SEDATIVE, BUT HYPOPNEA AND A DECREASE IN BLOOD PRESSURE WERE OBSERVED. DURING THE PROCEDURE THE PHYSICIAN USED AN AMPLATZER TORQVUE DELIVERY SYSTEM (LOT#6960433) AND UPON WITHDRAWAL OF THE DILATOR FROM THE DELIVERY SHEATH, THE PATIENT SNORED LOUDLY AND INFERIOR LEAD, ST ELEVATION, AND ADDITIONAL BLOOD PRESSURE DECREASE WERE CONFIRMED ON THE ECG MONITOR. AN AIR BUBBLE ENTERED UPON WITHDRAWAL OF THE SHEATH CAUSING AN AIR EMBOLUS IN THE CORONARY ARTERY. THE PHYSICIAN SUSPECTS THAT AIR CAME INTO THE SHEATH WHEN CONNECTING THE LOADING ASSEMBLY TO THE SHEATH AND THE LACK OF A HEMOSTASIS VALVE BEING ON THE SHEATH CAN ALLOW FOR AIR TO ENTER. THE PATIENT WAS IMMEDIATELY PUT UNDER GENERAL ANESTHESIA FOR STABILIZING THEIR BLOOD PRESSURE. THERE WAS NO NEURAL PROBLEM AND THE PATIENT¿S BLOOD PRESSURE AND BREATHING STABILIZED, THEREFORE THE PFO WAS SUCCESSFULLY DEPLOYED IN THE PATIENT¿S DEFECT. DUE TO THE FOLLOWING EVENTS, THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE. DURING EXTUBATION THE PATIENT EXP

  Patient problems: Air Embolism; Decreased Respiratory Rate; Low Blood Pressure/ Hypotension; Paralysis; Seizures

  MAUDE report 10121121 ↗
• InjuryMay 13, 2020Device Handling Problem; Device Handling Problem

  ON (B)(6) 2020, JUST PRIOR TO DEPLOYING THE DEVICE, THE PHYSICIANS NOTICED THAT AIR HAD GOT INTO THE LEFT VENTRICLE (AIR EMBOLISM) AND THE PATIENT WASN¿T RESPONDING. AIR WAS ASPIRATED HOWEVER PATIENT STILL HAD SUFFERED A STROKE WHICH IMAGING HAD CONFIRMED POST PROCEDURE. THE PHYSICIAN DEPLOYED THE DEVICE TO PREVENT FURTHER COMPLICATIONS. THE USER, ALONG WITH OTHER PHYSICIANS PRESENT DURING THE PROCEDURE, AGREED IT WAS LIKELY CAUSED BY TAKING OUT THE ¿INTRODUCER¿ TOO QUICKLY THUS ALLOWING AIR TO ENTER. PATIENT IS RECOVERING WELL.

  Patient problems: Air Embolism; Infarction, Cerebral; Loss of consciousness

  MAUDE report 10053726 ↗
• InjurySep 17, 2019Gas/Air Leak; Gas/Air Leak

  ON AN UNKNOWN DATE AN AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, BUBBLES WERE VISUALIZED IN THE DELIVERY SHEATH LOADER AND THE PATIENT EXPERIENCED ST ELEVATION WITH CHEST PAIN. NO AIR WAS VISUALIZED IN THE PATIENT. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THE USER TESTED THE DEVICE EX VIVO AND REPLICATED THE ISSUE. FOLLOWING THE PROCEDURE. THE PATIENT WAS ASYMPTOMATIC.

  Patient problems: Air Embolism

  MAUDE report 9075043 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER NUMBER: 2135147-2019-00294. ON (B)(6) 2019, A 30 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. UPON DEPLOYMENT IT WAS NOTED THE DEVICE DIDN'T SATISFACTORILY ATTACH TO THE AORTIC RIM DUE TO THE PATIENT'S ANATOMY, SO THE USER ATTEMPTED TO WITHDRAW THE DEVICE; HOWEVER, THE DEVICE WAS REPORTED TO BE DEFORMED RESULTING IN DIFFICULTY RETRACTING THE DEVICE. THE DELIVERY SHEATH WAS THEN ADVANCED OVER THE OCCLUDER TO SUCCESSFULLY RECAPTURE THE DEVICE. THE DEVICE WAS REMOVED, AN ECHOCARDIOGRAM WAS PERFORMED WHICH CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT WAS SENT TO THE OPERATING ROOM, AND THE SEPTAL DEFECT AND ATRIAL PERFORATION WERE BOTH SURGICALLY CLOSED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 8996822 ↗
• InjuryAug 6, 2019Material Perforation; Material Perforation

  ON (B)(6) 2019, A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. THE PROCEDURE WAS COMPLEX AS THE PATIENT'S DEFECT WAS VERY APICAL. THERE WAS ALSO THE PRESENCE OF A PSEUDO-ANEURYSM LOCATED ON THE LATERAL WALL OF THE VD (VENTRICLE DEFECT) AND A LITANY OF TRABECULATIONS. AS THE PHYSICIAN WAS GETTING READY TO DEPLOY THE DEVICE AND A PERICARDIAL EFFUSION ON THE LATERAL SIDE OF THE VD WAS NOTED. THE PHYSICIAN QUICKLY DEPLOYED THE OCCLUDER AND PUNCTURED THE PERICARDIUM. 220CC OF BLOOD WAS EXTRACTED AND AFTER 125 MINUTES, A PERICARDIAL DRAIN WAS SET IN PLACE AND THE BLEEDING STOPPED. THE PROCEDURE TOOK LONGER THAN ANTICIPATED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. MANUFACTURER REPORT NUMBER: 2135147-2019-00223.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 8865392 ↗
• InjuryNov 2, 2018Retraction Problem; Retraction Problem

  ON (B)(6) 2018, A 24MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6184089) WAS DEPLOYED USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT NUMBER: 5790870). WHILE REPOSITIONING THE DEVICE, THE LA DISC FAILED TO BE RE-CAPTURED. THE PHYSICIAN REMOVED THE DEVICE THROUGH THE FEMORAL VEIN AND THE CASE WAS ABORTED. THE PATIENT WAS TAKEN TO SURGERY TO CLOSE THE ASD. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8032679 ↗
• InjurySep 7, 2018Premature Activation; Premature Activation

  DURING THE PROCEDURE, THE 20 MM AMPLATZER SEPTAL OCCLUDER (ASO) PREMATURELY RELEASED INSIDE THE 10F AMPLATZER TORQVUE 45 DELIVERY SYSTEM AND EMBOLIZED TO THE PULMONARY ARTERY. THE LEFT ATRIAL DISC HAD BEEN FULLY DEPLOYED AND THE RIGHT ATRIAL DISC WAS PARTIALLY DEPLOYED WHEN IT BECAME DETACHED. AN ATTEMPT TO SNARE THE ASO WAS PERFORMED; HOWEVER, THE PATIENT WAS SENT TO SURGERY FOR DEVICE REMOVAL AND DEFECT CLOSURE. THE PATIENT CONDITION BEFORE AND DURING THE PROCEDURE WAS STABLE. THE PATIENT IS RECOVERING AND IS REPORTED TO BE STABLE. THE DEVICE AND DELIVERY CABLE WERE DISCARDED AND WERE NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7856207 ↗