Amplatzer™ Vascular Plug 4 (REF 9-AVP038-008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00811806012384), received between Dec 14, 2020 and Jun 27, 2025 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8MM AMPLATZER VASCULAR PLUG IV WAS SELECTED FOR IMPLANT. DURING PROCEDURE, MALFORMATION OF THE NITINOL WIRE WAS OBSERVED. THE DEVICE DEFORMED WITH A BULBOUS SHAPE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE PLUG WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND REMOVED. NO DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350612 ↗
• InjuryFeb 12, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2024, A 8MM AMPLATZER VASCULAR PLUG IV WAS CHOSEN FOR IMPLANTATION INTO ATRIAL SEPTAL DEFECT (ASD) AND PATENT FORAMEN OVALE (PFO) WITH SIGNIFICANT PROTRUSION INTO THE AORTA UTILIZING A NON-ABBOTT DELIVERY SYSTEM. AN AMPLATZER SIZING BALLOON II WAS USED TO SIZE THE DEFECT. AFTER RELEASE OF THE 8MM AMPLATZER VASCULAR PLUG IV, THE DEVICE WAS THOUGHT TO BE TOO LARGE BY THE PHYSICIAN. THE DEVICE WAS RETRIEVED WITH A BIOPTOME. A REPLACEMENT 6MM AMPLATZER VASCULAR PLUG IV WAS THEN IMPLANTED SUCCESSFULLY WITH NON-ABBOTT DELIVERY SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685724 ↗
• MalfunctionNov 6, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8MM AMPLATZER VASCULAR PLUG IV WAS CHOSEN FOR PROCEDURE. DURING DEVICE PREPARATION, IT WAS NOTED THERE WAS A DISCREPANCY BETWEEN THE DEVICE'S OUTER PACKAGING AND INNER PACKAGING. ON ONE LABEL, IT WAS STATED THE COMPATIBLE CATHETER'S INNER DIAMETER TO BE GREATER THAN OR EQUAL TO 0.038IN. ON THE OTHER LABEL, IT STATED THE COMPATIBLE CATHETER'S INNER DIAMETER TO BE LESS THAN OR EQUAL TO 0.038IN. IT WAS REPORTED THE DEVICE WAS STILL USED IN THE PROCEDURE WITHOUT ADDITIONAL ISSUES OR DELAY WITH A 0.038 INCH INNER DIAMETER NON-ABBOTT DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073417 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, "TRANSCATHETER CLOSURE OF TUBULAR PDA WITH AMPLATZER PLUG 4 IN PRETERM INFANTS WEIGHING BETWEEN 900 AND 3,400 G: THE PROS AND CONS", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A PATIENT BORN AT 31 GESTATIONAL WEEKS, WEIGHING 2600G AT TIME OF INTERVENTION WITH COMORBIDITIES PATENT DUCTUS ARTERIOSUS (PDA), SEVERE BRONCHOPULMONARY DYSPLASIA (BPD) AND PULMONARY HYPERTENSION (PH). IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 8X13.5MM AMPLATZER VASCULAR PLUG 4 WAS IMPLANTED. IT WAS LATER REPORTED 3 MONTHS POST-PROCEDURE ON AN UNKNOWN DATE, IT WAS NOTED THERE WAS A LEFT PULMONARY ARTERY (LPA) OBSTRUCTION DUE TO THE DEVICE JAILING THE HYPOPLASTIC LPA. A DECISION WAS MADE TO RECANALIZE THE OBSTRUCTED LPA AND A STENT WAS IMPLANTED. THE ARTICLE CONCLUDED IMPLANTATION OF THE AP4 USING A 4 F 0.38 GUIDE WIRE-COMPATIBLE CATHETER WITHOUT INSERTING A LONG SHEATH MAKES THE CLOSURE OF TUBULAR DUCTS WITH THIS DEVICE FEASIBLE AND UNCOMPLICATED WITH A SHORT INTERVENTION TIME. HOWEVER, THE LIMITED SIZES WITH FIXED LENGTHS OF THE AP4 MAKE IT UNSUITABLE FOR DUCTS WIDER THAN 4.5 MM AND SHORTER THAN THE CHOSEN DEVICE LENGTH, WHICH CAN INCREASE THE RISK OF SIGNIFICANT LEFT PULMONARY STENO

  Patient problems: Obstruction/Occlusion

  MAUDE report 18065382 ↗
• InjuryJul 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 8MM AMPLATZER VASCULAR PLUG IV WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE VESSEL DIAMETER 6.02MM UNDER COMPUTED TOMOGRAPHY ANGIOGRAPHY MEASUREMENT. THE DEVICE WAS SUCCESSFULLY DEPLOYED BUT WAS UNABLE TO ACHIEVED OCCLUSION AFTER 19MIN OF WAITING. THE PHYSICIAN ALLEGED THAT PATIENT VESSEL PROBLEM, AS PATIENT HAS MYCOTIC ANEURYSM OF IIA WAS THE CAUSE FOR THE DEVICE NOT TO ARCHIVED OCCLUSION. A NON-ABBOTT DEVICE WAS IMPLANT TO ACHIEVE OCCLUSION. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267188 ↗
• MalfunctionJun 27, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  THE ARTICLE, "CASE REPORT: STENOSIS TURNED LEAK AND TURNED STENOSIS¿COMPLICATIONS OF PARAVALVULAR PROSTHETIC LEAK CLOSURE WITH A PLUG DEVICE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 79-YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION, PERMANENT ATRIAL FIBRILLATION, AND PROGRESSING AORTIC STENOSIS PRESENTED AT THE HOSPITAL FOR DYSPNOEA AND PERIPHERAL EDEMA. IT WAS REPORTED ON AN UNKNOWN DATE, A 23MM NON-ABBOTT VALVE WAS IMPLANTED IN THE PATIENT. FOLLOWING IMPLANT, IT WAS REPORTED THERE WAS MILD PARAVALVULAR LEAK (PVL). IMMEDIATELY POST-PROCEDURE, THE PATIENT EXPERIENCED LEFT BUNDLE BRANCH BLOCK AND A PERMANENT PACEMAKER WAS IMPLANTED. IT WAS THEN REPORTED ONE MONTH LATER, THE PATIENT PRESENTED WITH ACUTE PULMONARY EDEMA AND HEART MURMUR DUE TO INCREASED PVL. A DECISION WAS MADE TO IMPLANT AN 8MM AMPLATZER VASCULAR PLUG (AVP) 4 TO OCCLUDE THE PVL. IT WAS REPORTED FIVE WEEKS LATER, THE PATIENT PRESENTED WITH ACUTE HEART FAILURE. ECHOCARDIOGRAPHY REVEALED MIXED AORTIC DISEASE WITH STENOSIS AND SIGNIFICANT PARAVALVULAR AORTIC REGURGITATION. THE PATIENT WAS REFERRED TO OPEN HEART SURGERY. DURING PROCEDURE, IT WAS FOUND THE AVP 4 HAD MIGRATED AND REORIENTED TOWARDS THE LEAFLE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 17206357 ↗
• InjuryJun 27, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  THE ARTICLE, "CASE REPORT: STENOSIS TURNED LEAK AND TURNED STENOSIS COMPLICATIONS OF PARAVALVULAR PROSTHETIC LEAK CLOSURE WITH A PLUG DEVICE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 79-YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION, PERMANENT ATRIAL FIBRILLATION, AND PROGRESSING AORTIC STENOSIS PRESENTED AT THE HOSPITAL FOR DYSPNOEA AND PERIPHERAL EDEMA. IT WAS REPORTED ON AN UNKNOWN DATE, A 23MM NON-ABBOTT VALVE WAS IMPLANTED IN THE PATIENT. FOLLOWING IMPLANT, IT WAS REPORTED THERE WAS MILD PARAVALVULAR LEAK (PVL). IMMEDIATELY POST-PROCEDURE, THE PATIENT EXPERIENCED LEFT BUNDLE BRANCH BLOCK AND A PERMANENT PACEMAKER WAS IMPLANTED. IT WAS THEN REPORTED ONE MONTH LATER, THE PATIENT PRESENTED WITH ACUTE PULMONARY EDEMA AND HEART MURMUR DUE TO INCREASED PVL. A DECISION WAS MADE TO IMPLANT AN 8MM AMPLATZER VASCULAR PLUG (AVP) 4 TO OCCLUDE THE PVL. IT WAS REPORTED FIVE WEEKS LATER, THE PATIENT PRESENTED WITH ACUTE HEART FAILURE. ECHOCARDIOGRAPHY REVEALED MIXED AORTIC DISEASE WITH STENOSIS AND SIGNIFICANT PARAVALVULAR AORTIC REGURGITATION. THE PATIENT WAS REFERRED TO OPEN HEART SURGERY. DURING PROCEDURE, IT WAS FOUND THE AVP 4 HAD MIGRATED AND REORIENTED TOWARDS THE LEAFLE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 17206349 ↗
• InjuryMar 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 A 8MM AMPLATZER VASCULAR PLUG IV WAS SELECTED FOR AN IMPLANT IN A PATIENT WITH AN IRREGULAR DEFECT, WHICH HAS THE LARGEST DIAMETER OF 4MM. AT THE BEGINNING OF THE PROCEDURE, THE 5F NON-ABBOTT DELIVERY CATHETER WAS IN PLACE AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. APPROXIMATELY 3 MINUTES POST IMPLANT THE DEVICE DID NOT EMBOLIZE THE DEFECT; THE CONTRAST AGENT WAS STILL PASSING THROUGH THE TARGET VESSEL DUE TO POOR ADHERENCE. THE PLUG WAS RETRIEVED VIA SNARE AND A NON-ABBOTT DEVICE WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556511 ↗
• MalfunctionNov 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 A 8MM AMPLATZER VASCULAR PLUG 4 WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT THE PLUG DID NOT SUFFICIENTLY EMBOLIZE THE PATIENT'S PULMONARY ARTERY, PROXIMAL TO THE DESCENDING AORTIC ARCH AFTER BEING DEPLOYED. AFTER 5 MINUTES OF OBSERVING, IT WAS NOTED THAT THE CONTRAST AGENT WAS STILL ABLE TO PASS THROUGH THE PULMONARY ARTERY. THE PULMONARY ARTERY HAD A LENGTH OF 16.8MM. THE DECISION WAS MADE TO REMOVE THE 8MM AMPLATZER VASCULAR PLUG 4 AND IMPLANT A NEW UNKNOWN DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848803 ↗
• MalfunctionJul 28, 2022Difficult to Fold, Unfold or Collapse; Use of Device Problem; Difficult to Fold, Unfold or Collapse; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER VASCULAR PLUG IV WAS CHOSEN FOR IMPLANT IN THE PULMONARY ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE PLUG HAD ELONGATED LONGER THAN ANTICIPATED DUE TO VESSEL CONFORMITY. WHEN POSITIONING THE DEVICE, THE PLUG WAS ELONGATING INTO A NEIGHBORING PULMONARY BRANCH. THE DEVICE WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. FOR REPLACEMENT, COILS WERE IMPLANTED INSTEAD. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. IT WAS NOTED THAT THE PATIENT HAD TORTUOUS ANATOMY. THE PATIENT IS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123384 ↗
• MalfunctionNov 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, AN 8 MM AMPLATZER VASCULAR PLUG 4 WAS CHOSEN FOR PROCEDURE TO EMBOLIZE A SIDE BRANCH OF THE VERTEBRAL ARTERY. DURING PROCEDURE, THE DEVICE ELONGATED TOO LONG DURING RELEASE, SO THE DECISION WAS MADE TO IMPLANT A 6 MM AMPLATZER VASCULAR PLUG 4 INSTEAD TO RESOLVE THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836667 ↗
• InjuryDec 14, 2020Failure to Disconnect; Failure to Disconnect

  ON (B)(6) 2020, AN 8MM AMPLATZER VASCULAR PLUG 4 WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE DEVICE WAS IN POSITION TO BE DEPLOYED, HOWEVER DID NOT DEPLOY. THEREFORE, THE PLUG WAS REMOVED AND A NEW UNKNOWN SIZED PLUG WAS SUCCESSFULLY IMPLANTED. NO ABNORMALITIES OR ANOMALIES WERE OBSERVED WITH THE PLUG THAT DID NOT DEPLOY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. A CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME WAS REPORTED BY THE PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11002793 ↗