Amplatzer™ 9-AVP2-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00811806010441), received between Jun 27, 2018 and Oct 24, 2025 — classified as 1 death, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER VASCULAR PLUG II WAS IMPLANTED IN THE PATIENT FOR RETROGRADE TRANSVENOUS OBLITERATION (PARTO). AFTER THE PROCEDURE, THE PATIENT PASSED AWAY.

  Patient problems: Gastrointestinal Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378754 ↗
• MalfunctionJan 31, 2024Fracture; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Separation Problem; Fracture; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Separation Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, 22MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT INTO THE LEFT INTERNAL ILIAC ARTERY USING A 7F NON- ABBOTT DELIVERY SYSTEM. THE DEVICE WAS PROPERLY PREPARED PER THE INSTRUCTIONS FOR USE (IFU). DURING PROCEDURE, THE PLUG WOULD NOT DETACH FROM THE WIRE WITH MULTIPLE ATTEMPTS OF TORQUEING THE WIRE COUNTER CLOCKWISE. WITH CONTINUED TORQUEING, THE WIRE EVENTUALLY FRACTURED LEAVING APPROXIMATELY 3CM OF WIRE STILL ATTACHED TO THE PLUG. THE PLUG WAS DEPLOYED IN A GOOD POSITION IN THE PATIENT BODY. 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: Foreign Body In Patient

  MAUDE report 18615452 ↗
• MalfunctionMar 9, 2023Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 22MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT WITH A NON-ABBOTT DELIVERY SYSTEM. IT WAS REPORTED THE PLUG EXHIBITED AN "ELONGATING" ABNORMAL SHAPE DURING DEPLOYMENT. THE DEVICE WAS RECAPTURED AND REPOSITIONED BUT MAINTAINED ITS ELONGATION SHAPE. A DECISION WAS MADE TO CONTINUE WITH THE PROCEDURE AND THE DEVICE WAS IMPLANTED IN THE PATIENT. THE PHYSICIAN COULD NOT CONFIRM IF THE ELONGATION SHAPE WAS DUE TO PATIENT ANATOMY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THEIR STATUS WAS REPORTED AS STABLE. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT OR ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16516615 ↗
• InjuryApr 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED A 22MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT ON (B)(6) 2022. THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS BEING FOR EMBOLIZATION OF A PERSISTENT LEFT SUPERIOR VENA CAVA ANOMALY. THE DIAMETER OF THE VENA CAVA WAS 18MM. INITIALLY THE DEVICE APPEARED TO BE FINE AND HAD EMBOLIZED THE VESSEL. AFTER RELEASING THE PLUG AND REMOVING ALL CATHETERS/SHEATHS, A FINAL ANGIOGRAM WAS PERFORMED WHICH REVEALED THE DEVICE HAD MIGRATED INTO THE PULMONARY VESSELS. THE DEVICE WAS THEN SNARED AND THE PLUG WAS REMOVED. THE PROCEDURE WAS ABORTED AND THE USER INDICATED A SECOND INTERVENTION WILL BE PERFORMED IN THE NEAR FUTURE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO PATIENT SYMPTOMS. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS NOTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191084 ↗
• MalfunctionNov 7, 2021Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT A 22MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR AN EMBOLIZATION PROCEDURE ON (B)(6) 2021. THE DEVICE WAS DEPLOYED THEN UNSCREWED FROM THE CABLE. THE PHYSICIAN THEN WAITED 15 MINUTES, HOWEVER THE LEAK WAS OBSERVED AND THE OCCLUDER WAS REMOVED FROM THE PATIENT. DEVICE WAS REPLACE WITH A NEW 22MM AMPLATZER VASCULAR PLUG II THAT COMPLETED THE PROCEDURE. PATIENT STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763821 ↗
• InjuryFeb 4, 2021Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

  ON (B)(6) 2020, A 22MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT TO OCCLUDE A PORTAL VEIN. THE PLUG WAS PREPARED PER THE IFU AND RELEASED FROM THE CABLE. HOWEVER, POST-IMPLANT, THE PLUG WAS OBSERVED TO OCCLUDE THE INFERIOR VENA CAVA (IVC). THEREFORE, THE PLUG WAS SNARED AND REMOVED FROM THE PATIENT. A NEW COMPETITOR'S ASD DEVICE WAS SUCCESSFULLY IMPLANTED. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE TIME WAS REPORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11278724 ↗
• InjuryJun 30, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A 22MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE DEVICE KEPT MIGRATING TO THE AORTA. THE PROSTHESIS WAS REMOVED AND AN AMPLATZER VASCULAR PLUG I WAS SUCCESSFULLY IMPLANTED INSTEAD. WHEN THE PATIENT BECAME CONSCIOUS, IT WAS NOTED THAT SHE HAD SUFFERED A RIGHT SIDE CEREBROVASCULAR ACCIDENT. THE PHYSICIAN STATED THAT THE EVENT MAY HAVE BEEN CAUSED BY THE PATIENT'S HISTORY OF HEPARIN INDUCED THROMBOCYTOPENIA, ACTIVATED CLOTTING TIME LEVELS AND THE MANEUVERING OF THE DEVICE. MEDICATION WAS ADMINISTERED TO THE PATIENT, AND IS REPORTED TO BE RECOVERING.

  Patient problems: Stroke/CVA

  MAUDE report 10215365 ↗
• InjuryJun 22, 2020Migration or Expulsion of Device; Off-Label Use; Patient-Device Incompatibility; Migration or Expulsion of Device; Off-Label Use; Patient-Device Incompatibility

  ON (B)(6) 2020, A PATIENT WITH PARAVALVULAR LEAK (PVL) ON THE MITRAL VALVE HAD A PROCEDURE WITH AMPLATZER DEVICES. THE PATIENT HAD ENDOCARDITIS OF THE MITRAL VALVE, CORONARY ARTERY DISEASE, MODERATE CALCIFICATION, AND PATIENT ANATOMY WITH LITTLE TORTUOSITY. IT WAS OBSERVED THAT THE TISSUE AROUND THE LEAK WAS FRIABLE. THE PHYSICIAN ATTEMPTED TO CLOSE THE LEAK WITH AN AMPLATZER SEPTAL OCCLUDER (ASO) (LOT # UNKNOWN), IT WAS MIS-SIZED AND EXCHANGED WITH ANOTHER ASO (LOT # UNKNOWN). THE SECOND ASO WAS MIS-SIZED EXCHANGED FOR AN AMPLATZER VASCULAR PLUG. THE AMPLATZER VASCULAR PLUG WAS MIS-SIZED TOO SMALL AND EXCHANGED FOR A 22MM AMPLATZER VASCULAR PLUG 2. THE DEVICE WAS RELEASED AND IMPLANTED. HOWEVER, DUE TO THE PATIENT ANATOMY AND THE TISSUE AROUND THE DEFECT, THE TISSUE AROUND THE DEFECT TORE AND THE PLUG EMBOLIZED TO THE RIGHT VENTRICLE. THE PLUG WAS SNARED AND PULLED INTO THE AORTA AND THE ILIAC. A SURGICAL INTERVENTION WAS THEN PERFORMED TO REMOVE THE DEVICE. THE FUTURE MANAGEMENT OF THE PVL WAS NOT DETERMINED. THE PATIENT IS CURRENTLY STABLE AND NO CONSEQUENCES WAS REPORTED POST DEVICE REMOVAL.

  Patient problems: Embolism; Mitral Perforation; Tissue Damage

  MAUDE report 10181891 ↗
• InjuryJan 12, 2020Material Deformation; Material Deformation

  ON (B)(6) 2019, A 22MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE RIGHT GASTRIC VEIN WAS IRREGULAR. WHEN THE DEVICE WAS DEPLOYED, THE MIDDLE LODE DID NOT OPEN AS EXPECTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND WAS REFLUSHED AND RE-PREPPED. DURING RE-PREP, THE DEVICE WAS DEPLOYED IN THE SALINE SOLUTION, BUT THE MIDDLE LOPE DID NOT OPEN. A 16MM DEVICE AND SCLEROSING AGENTS WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9579540 ↗
• InjuryNov 7, 2018Fracture; Fracture

  ON (B)(6) 2018, A 22MM AMPLATZER VASCULAR PLUG II (AVP2) WAS USED AS A DEMONSTRATION DEVICE PRIOR TO PROCEDURE TO REFRESH THE PHYSICIANS ON DEVICE PREPARATION AND DEPLOYMENT. DURING DEVICE PREPARATION, SLIGHT RESISTANCE WAS ENCOUNTERED WHEN THE LOADER WAS BACKED INTO THE SHEATH AND WHEN THE PLUG WAS ADVANCED SMOOTHLY INTO THE SHEATH. THE DEVICE WAS DEPLOYED IN THE PATIENT, AND THE WIRE TIP DETACHED AND REMAINED ATTACHED TO THE PROXIMAL MARKER OF THE PLUG. AFTER MULTIPLE ATTEMPTS, THE DEVICE WAS NOT OCCLUDING; HOWEVER, THE DEVICE WAS STILL RELEASED AND LEFT IMPLANTED WITH THE WIRE STILL ATTACHED. TWENTY-FIVE MINUTES LATER, FLUOROSCOPY SHOWED BLOOD FLOW, AND THE PATIENT'S PLATELETS WERE A BIT LOW, HOWEVER NO LAB TEST WAS PERFORMED FOR EXACT NUMBERS. A FOLLOW-UP VISIT IS PLANNED TO SEE WHETHER THE DEVICE OCCLUDED BLOOD FLOW. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Information

  MAUDE report 8047787 ↗
• InjuryJun 27, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018 A USER ELECTED TO USE A RE-STERILIZED 22MM AMPLATZER VASCULAR PLUG II. THE DEVICE WAS IMPLANTED AND AFTER IMPLANT, A RESIDUAL SHUNT REMAINED AND A 9MM AMPLATER DUCT OCCLUDER (LOT NUMBER: 6172614) WAS IMPLANTED TO DECREASE THE FLOW. ON (B)(6) 2018, A STEP IN THE FISTULA WAS OBSERVED, AND AGAIN THE USER ELECTED TO USE A RE-STERILIZED 12MM AMPLATZER VASCULAR PLUG II (LOT NUMBER: 5916435) AND COILS (MANUFACTURER UNKNOWN) WERE USED TO ADDRESS THE RESIDUAL SHUNTING. THE USER ELECTED TO USE RE-STERILIZED DEVICES EVEN THOUGH THE SITE HAD NEW DEVICES AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642129 ↗