Amplatzer™ 9-PDA2-03-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00811806011189), received between Oct 12, 2021 and Jan 20, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 3MM-6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR A PROCEDURE USING A NON-ABBOTT SHEATH. DURING PROCEDURE, THE DEVICE'S DISCS WAS NOT OPENING & THERE WAS A BULBOUS DEFORMATION NOTICED. 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 GOT ABORTED. 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 DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118752 ↗
• MalfunctionMay 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 3MM X 6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT USING A NON-ABBOTT DELIVERY SHEATH. DURING THE PROCEDURE THE OCCLUDER TOOK ON A COBRA SHAPE. MULTIPLE ATTEMPTS WERE MADE TO RE-DEPLOY THE OCCLUDER, HOWEVER THE UNUSUAL SHAPE MAINTAINED. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN 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 21988188 ↗
• MalfunctionJun 13, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 3MM BY 6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 5F NON-ABBOTT DELIVERY SHEATH. WHEN THE DEVICE WAS DEPLOYED, THERE WAS A COBRA DEFORMATION. THE DEVICE WAS RECAPTURED AND ATTEMPTED TO REDEPLOY BUT STILL HAD A DEFORMATION. THERE WERE NO OTHER DEVICES OF THE SAME SIZE AVAILABLE, SO THE PROCEDURE WAS TERMINATED WITHOUT IMPLANTING ANY DEVICE. THERE WAS NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM, THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT, AND THERE WAS NO INTERACTION WITH ANY CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121458 ↗
• InjuryMay 15, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 3MM X 6MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT WITH A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT DEFECT WAS SIZED 2.5-3.0MM VIA ANGIOGRAM. AFTER RELEASING THE DEVICE FROM THE DELIVERY CABLE, IT WAS NOTED THE DEVICE HAD EMBOLIZED INTO THE PULMONARY ARTERY. THERE WAS NO REPORT OF ANY PARTIAL OR COMPLETE BLOCKAGE OF BLOOD FLOW. A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE. IT WAS REPORTED THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO EXPLANT PROCEDURE BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935828 ↗
• InjuryFeb 15, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 3MMX6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANTATION. DURING THE PROCEDURE, AFTER RELEASING THE DEVICE FROM THE DELIVERY SYSTEM, IT WAS NOTED THAT THE DEVICE WAS NOT FITTING INTO THE DEFECT PROPERLY, AND THE DEVICE EMBOLIZED. IT WAS DECIDED THAT THE PATIENT REQUIRED SURGICAL INTERVENTION TO TREAT THE DEFECT AND REMOVE THE DEVICE. NO ADVERSE PATIENT EFFECTS. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381030 ↗
• MalfunctionDec 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 6 MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE THE DEVICE WAS DEPLOYED, IT PRESENTED IN A COBRA DEFORMATION. THE DEVICE WAS RECAPTURED AND REPLACED WITH A NEW DEVICE TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060518 ↗
• MalfunctionOct 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 3-6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT. DURING PROCEDURE, WHILE INSIDE THE PATIENT, ONE OF THE DISCS DID NOT DEPLOY INTO THE DESIRED SHAPE; IT WAS BULBOUS. THE USER ATTEMPTED TO DEPLOY THE DEVICE TWICE. AN UNKNOWN SIZED, UNKNOWN DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619075 ↗