Amplatzer™ 9-AVP2-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00811806010427), received between Nov 30, 2018 and Mar 18, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 18MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE DEVICE WAS PREPARE PER IFU, BUT THE CABLE CONNECTION WAS NOT CHECKED. DURING PROCEDURE, THE PLUG FAILED TO ADVANCE IN THE DELIVERY CATHETER AT THE TIME OF RELEASE. THE CABLE CONNECTION WAS NOT CHECKED PRIOR TO ATTEMPTED DEPLOYMENT. THE PLUG CAME LOOSE INSIDE THE CATHETER AND THE ENTIRE SYSTEM WAS REMOVED TOGETHER. A NEW 14MM AMPLATZER VASCULAR PLUG II WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635131 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO DIFFICULTY IMPLANTING THE 18MM AMPLATZER VASCULAR PLUG 2. THE PATIENT WAS ADMINISTERED ZOPICLONE FOR THEIR HYPO AND HYPERACTIVE DELIRIUM. THE PATIENT REPORTED A LAPSE IN MEMORY FROM (B)(6) 2024 . THE CAUSE OF THE PATIENT'S HYPO AND HYPERACTIVE DELIRIUM IS UNKNOWN, BUT THE PATIENT'S AGE AT THE TIME OF PROCEDURE WAS A KNOWN MAJOR RISK FACTOR. IT WAS NOTED THAT THE PATIENT ALSO HAS A HISTORY OF MEMORY DEFICITS. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE.

  Patient problems: Cognitive Changes

  MAUDE report 19811161 ↗
• MalfunctionApr 2, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 18MM AMPLATZER VASCULAR PLUG 2 WAS IMPLANTED IN A PATIENT. DURING THE PROCEDURE, IT WAS NOTED THAT A BULBOUS DEFORMATION OCCURRED. THE DEVICE WAS NOT REMOVED FROM THE DELIVERY SYSTEM WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WERE NO ANGULATIONS OR KINK NOTED IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED BUT NOT REPLACED. THE PATIENT'S STATUS WAS NOTED AS RECOVERY. NO DEVICE WAS ULTIMATELY IMPLANTED. NO ADVERSE CONSEQUENCES WERE EXPERIENCED RELATED TO THIS EVENT. THE HEALTHCARE PROFESSIONAL DID NOT BELIEVE THAT THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19026283 ↗
• MalfunctionDec 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 18MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR AN IMPLANT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN EMBOLIZATION OF ILIAC ANEURYSM. THE NECK OF THE TUMOR WAS SHAPED LIKE AN IRREGULAR LONG TUBE. FIRST, THE TUMOR WAS EMBOLIZED WITH AN 18MM VASCULAR PLUG. 3 MINUTES LATER, SOME OF THE CONTRAST AGENT STILL LEAKED NEAR THE ILIAC ARTERY, AND WAS FINALLY REPLACED WITH A LARGER SIZE VASCULAR PLUG TO COMPLETE THE CLOSURE AFTER REMOVAL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322607 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, ¿HEMODIALYSIS-RELATED PORTAL-SYSTEMIC ENCEPHALOPATHY: A RARE CAUSE OF RECURRENT ENCEPHALOPATHY AMONG PATIENTS ON MAINTENANCE HEMODIALYSIS" WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF A 50 YEARS OLD MALE WITH HISTORY OF DIABETES MELLITUS (DM) WITH MICROVASCULAR COMPLICATIONS, WAS INITIATED ON HEMODIALYSIS THROUGH RIGHT IJV CUFFED CATHETER FOLLOWING IRREVERSIBLE ACUTE ON CHRONIC KIDNEY DISEASE DUE TO SUPERADDED INFECTION-RELATED GN¿ ON UNDERLYING ADVANCED DIABETIC NEPHROPATHY. HE HAD LOW C3 LEVELS AND KIDNEY BIOPSY HAD SHOWN DIFFUSE PROLIFERATIVE GLOMERULONEPHRITIS WITH BACKGROUND DIABETIC NODULAR GLOMERULOSCLEROSIS, 5 OF 13 GLOMERULI SHOWED CELLULAR CRESCENTS. THE RENAL FUNCTION PROGRESSIVELY DETERIORATED DESPITE TRIAL OF STEROIDS. HIS PAST HISTORY WAS SIGNIFICANT FOR AN EPISODE OF ACUTE PANCREATITIS, ACUTE CORONARY SYNDROME ON MEDICAL MANAGEMENT AND REGULAR ALCOHOL CONSUMPTION. TWO MONTHS INTO HD HE DEVELOPED ACUTE ONSET ALTERED MENTAL STATUS. ON EXAMINATION, HE HAD GAIT INSTABILITY AND FLAPS. HIS SERUM AMMONIA LEVEL WAS ELEVATED (67 MMOL/L) DESPITE ACCEPTABLE UREA REDUCTION RATES ON HEMODIALYSIS. ULTRASOUND ABDOMEN SHOWED FATTY LIVER AND UPPER GI ENDOS

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 14838348 ↗
• MalfunctionMar 1, 2022Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED A 18MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR PROCEDURE. DURING THE PROCEDURE, AN ATTEMPT TO ADVANCE THE DEVICE THROUGH A 7FR SHEATH WAS MADE AND THE USER REPORTED FEELING RESISTANCE. THE SHEATH WAS EXCHANGED WITH A LARGER 8FR SHEATH AND THE DEVICE WAS ABLE TO BE DEPLOYED. THE USER REPOSITIONED AND RE-SHEATHED THE DEVICE 3 TO 4 TIMES. DURING THE LAST ATTEMPT TO DEPLOY THIS DEVICE, WHILE INSIDE THE PATIENT, THE DEVICE PRESENTED WITH A DEFORMATION ON ONE OF THE DISCS, ITS SHAPE UNSPECIFIED. STILL ATTACHED TO THE CABLE, THE DEVICE WAS REMOVED AND EXCHANGED WITH AN UNKNOWN SIZE AVPI DEVICE AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT DID REMAIN STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638446 ↗
• InjuryAug 29, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2019, AN OFF LABEL AVP2 WAS ATTEMPTED IN THE MITRAL VALVE POSITION BETWEEN 2 PREVIOUS MITRACLIP IMPLANTED HOWEVER, THE PATIENT WAS NOT AN IDEAL MITRACLIP CANDIDATE BUT WAS NON- SURGICAL AND HAD NO OTHER ALTERNATIVES BUT TO ATTEMPT MITRACLIP. FOLLOWING THE PROCEDURE, SEVERE MR (MITRAL REGURGITATION) REMAINED AND THE PATIENT REMAINED IN A NEAR CARDIOGENIC SHOCK STATE. ON (B)(6) 2019, THERE WAS AN ATTEMPT TO PLACE AN 22MM AMPLATZER VASCULAR PLUG II BETWEEN THE 2 MITRACLIP. A PLUG (BATCH NUMBER: 701807) WAS DEPLOYED BETWEEN THE CLIPS HOWEVER, DISLODGED PRIOR TO BEING RELEASED. THE PLUG WAS RE-SHEATHED AND REMOVED AND WAS EXCHANGED FOR 18MM AMPLATZER VASCULAR PLUG II (BATCH NUMBER: 6996646). THE SECOND PLUG WAS ATTEMPTED TO IMPLANTED BUT WAS UNSUCCESSFULLY PLACED. THE 22MM AMPLATZER VASCULAR PLUG II (BATCH NUMBER: 701807) WAS RE-INTRODUCED AND DEPLOYED AND APPEARED TO BE IN GOOD POSITION. AN ECHOCARDIOGRAM WAS PERFORMED AND A DECREASE IN MR WAS NOTED HOWEVER, INCREASE IN THE PATIENT'S BLOOD PRESSURE WAS REPORTED. WITH IN MINUTES OF SUCCESSFUL DEPLOYMENT OF THE 18MM AMPLATZER VASCULAR PLUG II THE DEVICE EMBOLIZED INTO THE LEFT ATRIUM (LA) AND IT WAS DECIDED TO LEAVE THE DEVICE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8944491 ↗
• InjuryNov 30, 2018Mechanical Problem; Mechanical Problem

  ON (B)(6) 2018, A 16MM AMPLATZER VASCULAR PLUG II (AVPII) WAS SELECTED FOR IMPLANT. AFTER BEING DEPLOYED THE DEVICE WAS UNABLE TO BE RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS EXCHANGED FOR AN 18MM AVPII (LOT NUMBER: 6268259) BUT THE SAME ISSUE OCCURRED WHICH EXTENDED THE PROCEDURE BY MORE THAN THIRTY MINUTES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8121716 ↗