Amplatzer™ 9-PDA-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00811806011141), received between Sep 20, 2018 and Dec 24, 2025 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16-14MM AMPLATZER PDA WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM FOR A PDA (PATENT DUCTUS ARTERIOSUS) PROCEDURE. DURING THE PROCEDURE, WHILE DEPLOYING THE OCCLUDER DUD NOT EXPAND PROPERLY. THE 16-14MM AMPLATZER PDA WAS RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE INSIDE THE PATIENT. ANOTHER 12-10MM AMPLATZER PDA WAS CHOSEN AS A REPLACEMENT BUT IT ALSO DID NOT EXPAND PROPERLY, THEREFORE IT WAS RETRIEVED OUT AND A NEW 12-10MM AMPLATZER PDA WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE DEFORMED DEVICES WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889313 ↗
• MalfunctionAug 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785093 ↗
• InjuryMay 20, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON 09 APRIL 2025, A 12-10MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR A PROCEDURE USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT A PATENT DUCTUS ARTERIOSUS (PDA). THE PDA WAS MEASURED AT 21.6MM. THE SIZING OF THE DEVICE WAS DETERMINED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). FLUOROSCOPY AND ICE WERE USED DURING THE PROCEDURE. DURING DEPLOYMENT THE OCCLUDER MOVED TO THE PULMONARY SIDE. AN ATTEMPT WAS MADE TO PARTIALLY RE-CAPTURE THE OCCLUDER AND RE-DEPLOY, HOWEVER THE OCCLUDER COULD NOT BE PARTIALLY RE-CAPTURED TO THE DELIVERY SYSTEM. UPON THE THIRD ATTEMPT TO RE-CAPTURE THE OCCLUDER, THE OCCLUDER PREMATURELY DETACHED FROM THE DELIVERY CABLE AND EMBOLIZED TO THE RIGHT PULMONARY BRANCH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE BUT WAS NOTED TO HAVE LOST A SMALL AMOUNT OF BLOOD. THE PATIENT WAS TRANSFERRED TO SURGERY TO REMOVE THE OCCLUDER. THE PATIENT STATUS WAS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22052943 ↗
• MalfunctionMar 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12-10MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F NON-ABBOTT DELIVERY SHEATH. IT WAS NOTED DURING PROCEDURE THAT THE OCCLUDER WAS NOT TAKING PROPER SHAPE WITH A COBRA DEFORMATION WHEN DEPLOYED. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE DECISION WAS MADE TO RECAPTURE AND REMOVE THE OCCLUDER FROM THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS ULTIMATELY ABORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691460 ↗
• InjuryDec 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, "REDO AORTIC VALVE REPLACEMENT FOR AN INCORRECTLY-SIZED RAPID DEPLOYMENT VALVE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 64-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION, EPILEPSY, GASTROESOPHAGEAL REFLUX DISEASE, BICUSPID AORTIC VALVE STENOSIS, AND A 56 MM ASCENDING AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PREVIOUSLY UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT SURGERY WITH A #25 INTUITY BIOPROSTHETIC VALVE WITH A #38 HEMASHIELD DACRON GRAFT. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 12-10MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR AN OFF LABEL USE TO TREAT MODERATE PARAVALVULAR LEAK (PVL) ASSOCIATED WITH THE INTUITY VALVE ACCOMPANIED WITH WORSENING FATIGUE AND HEMOLYTIC ANEMIA. AFTER IMPLANT OF THE OCCLUDER ACROSS THE PVL, IT WAS NOTED THERE WAS COMPLETE ELIMINATION OF PVL IT WAS THEN REPORTED ON AN UNKNOWN DATE THREE YEARS POST-INTERVENTION, THE PATIENT PRESENTED WITH FATIGUE AND DIZZINESS. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED SEVERE PVL AND MEAN GRADIENT OF 16.5MMHG ACROSS THE AORTIC VALVE. A DECISION WAS MADE TO REDO AORTIC VALVE REPLACEMENT. DURING REINTERVENTION, IT WAS NOTED THE OCCLUDER HAD FAILED TO COVER THE GAP BETWEEN THE SUBVALVU

  Patient problems: Fatigue; Movement Disorder

  MAUDE report 18321906 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT A 12-10MM AMPLATZER DUCT OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT THAT WAS PREVIOUSLY DIAGNOSED WITH A PATENT DUCTUS ARTERIOSUS DEFECT AND SUSTAINED ATRIAL FIBRILLATION. IT WAS NOTED THE FOLLOWING DAY AFTER IMPLANT, THAT ALTHOUGH THE PATIENT DID NOT EXPERIENCE ANY CHEST SYMPTOMS, A "HUGE NEGATIVE T-WAVE" WAS DETECTED ON AN ELECTROCARDIOGRAM. THE PATIENT WAS EXPERIENCING AN ARRHYTHMIA, BUT THERE WAS NO ELEVATION OF SERUM CREATINE KINASE DETECTED. IT WAS NOTED THAT THE PATIENT'S LEFT VENTRICLE APEX HAD BECOME BALLOONED AND THERE WAS EXCESSIVE CONTRACTION AT THE BASE OF THE LEFT VENTRICLE. THE PATIENT WAS DIAGNOSED WITH TAKO-TSUBO-LIKE LEFT VENTRICULAR DYSFUNCTION. THE PATIENT WAS ADMINISTERED AN ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITOR. A WEEK LATER, THE LEFT VENTRICLE FUNCTION IMPROVED AND THE NEGATIVE T-WAVE DETECTED ON THE ELECTROCARDIOGRAM HAD NORMALIZED. THEREAFTER, THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OF CONGESTIVE HEART FAILURE FOR TWO YEARS. THE ARTICLE CONCLUDES THAT AFTER THE CLOSURE OF THE PATENT DUCTUS ARTERIOSUS, THE PRELOAD OF THE LEFT VENTRICLE DECREASES. HOWEVER IN THIS CASE STUDY THE AFTERLOAD OF THE L

  Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure

  MAUDE report 15618087 ↗
• MalfunctionSep 7, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 12-10MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT THE AMPLATZER DUCT OCCLUDER EXHIBITED A DEFORMATION WHEN BEING DEPLOYED THROUGH A 8FR NON-ABBOTT DELIVERY SHEATH. THE DECISION WAS MADE TO REPLACED THE 12-10MM AMPLATZER DUCT OCCLUDER WITH ANOTHER AMPLATZER DUCT OCCLUDER OF A DIFFERENT UNKNOWN SIZE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375631 ↗
• MalfunctionJul 12, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 12-10MM AMPLATZER PATENT DUCTUS ARTERIOSUS (PDA) OCCLUDER WAS SELECTED FOR PROCEDURE. REPORTEDLY, DURING PROCEDURE THE AMPLATZER PDA OCCLUDER EXHIBITED A DEFORMATION UPON DEPLOYMENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO KINK OR ANGULATION NOTED IN THE DELIVERY SYSTEM. THE DECISION WAS MADE TO RECAPTURE THE DEVICE AND REMOVE IT. ULTIMATELY, THE IMPLANT PROCEDURE WAS ABORTED BECAUSE OF THE DEFORMATION THAT OCCURRED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992445 ↗
• MalfunctionFeb 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED A 7MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT. DURING THE PROCEDURE, WHILE THE DEVICE WAS BEING NAVIGATED THROUGH AN 8FR MULLINS SHEATH, DURING THE DEPLOYMENT THE DEVICE PRESENTED IN A COBRA SHAPE. THE DEVICE WAS REMOVED AND THE PATIENT WAS TAKEN FOR SURGICAL REPAIR OF THE DEFECT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13528590 ↗
• InjuryMar 3, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2021, A 7MM AMPLATZER DUCT OCCLUDER WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. A FEW HOURS POST-PROCEDURE, IT WAS DISCOVERED DURING TTE THAT THE DEVICE EMBOLIZED INTO THE PULMONARY VEIN. THE PHYSICIAN ATTEMPTED TO CAPTURE THE DEVICE WITH A SNARE, BUT WAS UNSUCCESSFUL. THAT SAME DAY, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO RETRIEVE THE DEVICE AND THE DUCT WAS SURGICALLY CLOSED. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Foreign Body Embolism

  MAUDE report 11408363 ↗
• MalfunctionDec 18, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, A 7MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT A COBRA DEFORMATION WAS NOTED. THE DEVICE WAS RECAPTURED AND REPLACED WITH AN UNKNOWN COMPETITOR DEVICES. THE PATIENT WAS REPORTED TO BE INSTABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11039093 ↗
• InjuryDec 5, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, A 12/10MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, BOTH THE DISCS "DID NOT OPEN PROPERLY" AND "FAILED WITH REPEATED ATTEMPT." THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW 12/10MM AMPLATZER DUCT OCCLUDER WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10951609 ↗
• InjuryDec 20, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ON AN UNKNOWN DATE A 7MM AMPLATZER DUCT OCCLUDER WAS IMPLANTED. POST IMPLANT THE DEVICE EMBOLIZED TO THE PA (PULMONARY ARTERY). THE PATIENT WAS BROUGHT BACK TO THE CATH LAB AND THE DEVICE WAS EXPLANTED. THE PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE BUT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION CANNOT BE OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507086 ↗
• InjuryNov 13, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018, A 12/10MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT PER IFU SIZING REQUIREMENTS. AFTER POSITIONING AND PLACING THE DEVICE, A GENTLE TUG TEST WAS PERFORMED. IMMEDIATELY AFTER RELEASING THE DEVICE, THE OCCLUDER EMBOLIZED TO THE ENTRANCE OF THE RIGHT PULMONARY ARTERY. THE PATIENT WAS SENT TO SURGERY TO RETRIEVE THE DEVICE AND CLOSE THE PDA. POST-OPERATIVELY, THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8066662 ↗
• InjurySep 20, 2018Material Deformation; Material Deformation

  ON (B)(6) 2018, A 12/10MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. WHEN THE OCCLUDER WAS DEPLOYED, IT CAME OUT IN A BALLOON SHAPE. THE PHYSICIAN REMOVED THE OCCLUDER FROM THE PATIENT AND REDEPLOYED THE OCCLUDER OUTSIDE THE PATIENT, BUT THE ISSUE PERSISTED. A 12/10MM OCCLUTECH OCCLUDER WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES, BUT THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND IS REPORTED STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7893323 ↗