Amplatzer™ Vascular Plug 4 (REF 9-AVP038-007)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00811806012377), received between Jun 4, 2019 and Nov 24, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Separation Problem; Premature Separation; Separation Problem; Premature Separation

  IT WAS REPORTED ON (B)(6) 2025 A 7MM AMPLATZER VASCULAR PLUG IV WAS SELECTED FOR IMPLANT. DURING IMPLANT THE PLUG COULD NOT BE DEPLOYED DUE TO THE SCREW MECHANISM. WHILE ATTEMPTING TO REMOVE THE PLUG FROM THE PATIENT THE PLUG RELEASED WITHIN THE DELIVERY CATHETER. THE PLUG WAS ABLE TO BE REMOVED FROM THE PATIENT THROUGH THE DELIVERY CATHETER. THERE WAS A CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE AS THE PATIENT CONTINUED TO ACTIVELY BLEED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23633193 ↗
• MalfunctionFeb 15, 2024Material Deformation; Separation Problem; Material Deformation; Separation Problem

  IT WAS REPORTED THAT ON (B)(6)2024, A 7MM AMPLATZER VASCULAR PLUG4 WAS CHOSEN FOR INTERNAL ILIAC ARTERY (IIA) EMBOLIZATION, USING A 4F NON-ABBOTT DELIVERY CATHETER. DEPLOYMENT WAS ATTEMPTED BY ROTATING COUNTERCLOCKWISE, BUT THE VALVE WAS NOT ABLE TO RELEASE. THE DELIVERY WIRE WAS OBSERVED TO UNRAVEL. IT IS THOUGHT THAT THE INNER LUMEN OF THE CONTRAST CATHETER MAY HAVE GOTTEN CAUGHT WITH THE DELIVERY WIRE. THE DEVICE WAS REMOVED, AND A REPLACEMENT 8MM AMPLATZER VASCULAR PLUG4 WAS SUCCESSFULLY USED. 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 18712480 ↗
• InjuryDec 6, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 3 MONTH OLD PATIENT WEIGHING 2.2 KG THAT WAS BORN PRE-TERM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 7MM AMPLATZER VASCULAR PLUG IV WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 5 MM. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE DEVICE HAD EMBOLIZED AND A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE AND REPLACE WITH A 8MM AMPLATZER VASCULAR PLUG II. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRESSURES IN YOUNGER AND SMALLER INFANTS ARE MORE OFTEN ASSOCIATED WITH DEVICE EMBOLISATION. TUBULAR DUCTS ARE MORE PRONE FOR EMBOLISATION COMPARED TO USUAL CONICAL DUCTS. SOFTER VASCULAR PLUGS ARE OFTEN ASSOCIATED WITH EMBOLISATIONS. INTENTIONAL DEVICE UNDERSIZING TO AVOID VASCULAR OBSTRUCTION IN SMALL PATIENTS IS A FREQUENT RISK FACTOR FOR EMBOLISATION. PRECISE ECHOCARDIOGRAPHIC MEASUREMENTS, CORRECT OCCLUDER CHOICE, PROPER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278817 ↗
• 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 24 GESTATIONAL WEEKS, WEIGHING 2500G AT TIME OF INTERVENTION WITH A PATENT DUCTUS ARTERIOSUS (PDA). IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 7X12.5MM AMPLATZER VASCULAR PLUG 4 WAS IMPLANTED. IT WAS REPORTED THE PULMONARY SIDE OF THE DEVICE "JAILED" THE LEFT PULMONARY ARTERY (LPA) AND CAUSED A NARROWING OF THE LPA ENTRANCE WITHOUT RESTRICTION OF THE LPA PERFUSION. A DECISION WAS MADE TO DILATE THE LPA ON AN UNKNOWN DATE 4 MONTHS AFTER IMPLANT PROCEDURE. 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 STENOSIS. A WIDE RANGE OF PLUG DIAMETERS AND LENGTHS IS REQUIRED TO ACCOMMODATE TH

  Patient problems: Obstruction/Occlusion

  MAUDE report 18066863 ↗
• InjuryMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, "TRANSCATHETER OCCLUSION OF A FEEDING VESSEL AND PNEUMONECTOMY IN A NEWBORN WITH THE INFANTILE FORM OF SCIMITAR SYNDROME", WAS REVIEWED. THE PURPOSE OF THIS CASE STUDY: AN INFANTILE TYPE OF SCIMITAR SYNDROME (SS) IS A RARE CONGENITAL CARDIOPULMONARY ANOMALY WHICH CAN LEAD TO PULMONARY HYPERTENSION AND HIGH MORTALITY IN CHILDREN. A TWO-STAGE APPROACH HAS BEEN PROPOSED FOR THE MANAGEMENT. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF A 10 DAY OLD EARLY TERM INFANT MALE WEIGHING 2290 GRAMS FROM A TWIN PREGNANCY. THE INFANT WAS TRANSFERRED TO THE AUTHOR'S HOSPITAL DUE TO INFERIOR RIGHT-SIDED PULMONARY ATELECTASIS AND PROLONGED DEPENDENCE ON MECHANICAL VENTILATION (MV). ON ADMISSION, THE PATIENT HAD SIGNS OF HEART FAILURE. ECHOCARDIOGRAPHY AND CT SCAN REVEALED INFANTILE TYPE SCIMITAR SYNDROME (SS), A HUGE ABNORMAL SYSTEMIC SUPPLY TO THE LUNG FROM THE ABDOMINAL AORTA, AND RIGHT LUNG HYPOPLASIA. IT WAS DECIDED TO PERFORM A PERCUTANEOUS OCCLUSION DUE TO THE PATIENT'S AGE, BODY WEIGHT AND RESPIRATORY PROBLEMS THAT MAY WORSEN AFTER SURGICAL LIGATION. CARDIAC CATHETERIZATION VIA FEMORAL VESSELS WITH 4-FRENCH WAS PERFORMED UNDER GENERAL ANESTHESIA. THE MASSIVE TORTUOUS ANOMALOUS V

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 16900356 ↗
• MalfunctionApr 24, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE VP4 COULD NOT PASS THROUGH 5FR COOK CATHETER. THE PHYSICIAN REPORTED THAT THE DEVICE WAS STUCK IN TIP OF CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9997834 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, AN AMPLATZER VASCULAR PLUG 4 WAS SELECTED FOR IMPLANT TO REDUCE BLOODFLOW TO A PARTICULAR ROUTE. AFTER THE DEVICE WAS PLACED, THE PATIENT BECAME HYPERTENSIVE SO THE DEVICE WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 8669063 ↗