Amplatzer™ 9-PDA2-05-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00811806011240), received between May 5, 2020 and Sep 25, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50901470 ↗
• MalfunctionMar 16, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6)2026, A 5MM BY 6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 5F NON-ABBOTT SHEATH. DURING DEPLOYMENT, THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT TAKING THE DESIRED SHAPE, SO THEY HAVE TO RETRIEVE THE DEVICE BACK. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PROCEDURE ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605229 ↗
• MalfunctionMar 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 5MM BY 6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 5F NON-ABBOTT SHEATH. DURING DEPLOYMENT, THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT TAKING THE DESIRED SHAPE, SO THEY HAVE TO RETRIEVE THE DEVICE BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589984 ↗
• MalfunctionNov 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 5MM X 6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE THE OCCLUDER TOOK ON AN UNUSUAL SHAPE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 4MM X 6MM AMPLATZER DUCT OCCLUDER II. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633195 ↗
• InjuryOct 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, ¿INTERMEDIATE AND LONG-TERM FOLLOW-UP OF TRANSCATHETER CLOSURE OF CONGENITAL CORONARY CAMERAL FISTULAS IN INFANTS AND CHILDREN: EXPERIENCE FROM A SINGLE CENTER¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 1.25-YEAR-OLD, 12KG PATIENT WITH A CORONARY CAMERAL FISTULA AND CORONARY ARTERY ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 5-6MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT TO OCCLUDE A CORONARY CAMERAL FISTULA. AFTER RELEASE OF THE DEVICE, COMPLETE RIGHT CORONARY ARTERY (RCA) OCCLUSION OCCURRED AND THROMBUS WAS DETECTED WITHIN THE OCCLUDED RCA. ACUTE INFERIOR MYOCARDIAL INFARCTION WAS CONFIRMED BY TWELVE-LEAD ELECTROCARDIOGRAPHY (ECG). A DECISION WAS MADE TO EXPLANT THE DEVICE VIA TRANSCATHETER SNARE AND THROMBUS WAS ASPIRATED FROM THE PATIENT. THE PATIENT WAS DISCHARGED ON HEPARIN FOR THREE DAYS FOLLOWED BY DUAL ANTI-PLATELET THERAPY WITH ASPIRIN AND CLOPIDOGREL FOR ONE MONTH. IT WAS REPORTED ANOTHER TRANSCATHETER CLOSURE WAS PLANNED AT AN UNKNOWN DATE. THE ARTICLE CONCLUDED THAT TCC OF CCFS IN INFANTS AND CHILDREN APPEARS TO BE EFFECTIVE AND IS ASSOCIATED WITH A RELATIVELY LOW COMPLICATION RATE. LARGE CCFS AND GIANT CORONARY ARTERY ANEURY

  Patient problems: Myocardial Infarction; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17912302 ↗
• MalfunctionJun 21, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A A 5-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT IN A PATIENT PATENT DUCTUS ARTERIOSUS (PDA) USING A NON ABBOT DELIVERY SHEATH. DURING DEPLOYMENT, THE PHYSICIAN NOTED THE DEVICE HAD A COBRA DEFORMATION AND THE PHYSICIAN RETRIEVED THE DEVICE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS TERMINATED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175403 ↗
• MalfunctionJun 15, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 05-06MM AMPLATZER DUCT OCCLUDER II WAS USED TO TREAT PATENT DUCTUS ARTERIOSUS (PDA), USING A NON-ABBOTT DELIVERY SYSTEM. DURING DEPLOYMENT, IT WAS NOTED THAT THE DEVICE DEFORMED TO A COBRA-LIKE SHAPE. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS ABORTED. THE PATIENT IS REPORTED TO BE STABLE. 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 17134962 ↗
• InjuryFeb 1, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM BY 6MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT. PRIOR TO THE PROCEDURE, THE DEFECT WAS MEASURED TO BE 4MM-6MM VIA ECHOCARDIOGRAM AND ANGIOGRAM IMAGING. THE OCCLUDER WAS IMPLANTED. IMMEDIATELY AFTER THE PROCEDURE, IT WAS SEEN VIA ANGIOGRAM AND ECHOCARDIOGRAM THAT THE DEVICE EMBOLIZED OUT OF THE DEFECT. THE DEVICE WAS THEN EXPLANTED IN A NON-EMERGENT SURGERY ON THE SAME DAY. THE PATIENT WAS REPORTED AS DISCHARGED. THE IMPLANTER ALLEGES THE EMBOLIZATION TO BE DUE TO A MIS-SIZING OF THE OCCLUDER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279292 ↗
• MalfunctionJan 16, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 4-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE, THE AORTIC RETENTION DISC WITH THE CENTRAL WAIST AND THE PULMONARY RETENTION DISC "WERE NOT ALIGNING" DURING DEPLOYMENT; "BOTH DISC ARE NOT ALIGNING SYMMETRICALLY TO EACH OTHER." A NEW 5-6MM AMPLATZER DUCT OCCLUDER WAS THEN SELECTED, HOWEVER THE SAME ISSUE OCCURRED. NO INTERACTION WITH CARDIAC STRUCTURES OCCURRED DURING DEPLOYMENT AND NO ANGULATION OR KINK WAS NOTICED WITH THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. A DELAY IN PROCEDURE WAS REPORTED WITH NO HEMODYNAMIC COMPROMISE. ULTIMATELY, A NON-ABBOTT DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16176319 ↗
• InjuryJan 10, 2023Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5MM X 6MM AMPLATZER DUCT OCCLUDER II SUCCESSFULLY IMPLANTED FOR A MITRAL PARAVALVULAR LEAK, NEXT TO AN IMPLANTED MECHANICAL MITRAL VALVE. THE VALVE MODEL AND MAKE UNKNOWN AND WAS IMPLANTED SOME TIME IN 2021. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCE SOME HEMOLYSIS THE IMPLANTED DEVICE. THE PATIENT WAS EXPERIENCING FATIGUE INCREASED TO A POINT BEYOND WHAT THE PATIENT WAS EXPERIENCING PRIOR TO PLACEMENT OF THE OCCLUDER. BLACK, BLOODY URINE AS WELL. A RECENT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND IT APPEARED FLOW WAS COMING THROUGH THE DEVICE WHEN THE PROXIMAL DISK WOULD OPEN DURING THE CARDIAC CYCLE. THE PHYSICIAN AND PATIENT REVIEWING OPTIONS TO HAVE THE DEVICE REMOVED OR ANOTHER DEVICE PLACED. IN NOVEMBER ON AN UNKNOWN DATE, THE PATIENT WAS SEEN BY A HEMATOLOGIST WHO REFERRED BACK TO IMPLANTING PHYSICIAN ONCE HEMOLYSIS WAS SUSPECTED AND RECEIVES WEEKLY BLOOD TRANSFUSIONS. PATIENT IS ON ANTICOAGULANT REGIME DUE TO PRIOR MECHANICAL VALVES IN BOTH AORTIC AND MITRAL POSITIONS IMPLANTED AT DIFFERENT TIMES. PATIENT IS STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16134473 ↗
• MalfunctionJul 12, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN AMPLATZER DUCT OCCLUDER II 5MM DIA 6MM WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE, DEVICE DISC WAS NOT OPENING UP PROPERLY. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE IS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. A NON-ABBOTT DEVICE WAS SELECTED AND IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983765 ↗
• InjuryMay 5, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A 4-4 AMPLATZER DUCT OCCLUDER II (4-4ADOII, LOT#: UNKNOWN) WAS ATTEMPTED TO BE IMPLANTED FOR A PATIENT'S PDA CLOSURE. HOWEVER, THE 4-4 ADOII SIZE WAS NOT SUITED FOR THE PDA. A LARGER-SIZED 5-6 AMPLATZER DUCT OCCLUDER II (5-6 ADOII) WAS IMPLANTED INSTEAD. THERE WAS SLIGHT RESIDUAL LEAK POST-IMPLANT, BUT NO AORTIC PRESSURE GRADIENT DIFFERENCE WAS CONFIRMED, AND SO THE IMPLANT PROCEDURE WAS COMPLETED. ON (B)(6) 2020, HOWEVER, THE 5-6 ADOII WAS REPORTED TO HAVE DISLODGED, FELL OFF TO THE PA SIDE. THE 5-6 ADOII WAS REMOVED FROM THE PATIENT USING A 5F SNARE CATHETER AND A NEW 6-6 AMPLATZER DUCT OCCLUDER II WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10025468 ↗