AMPLATZER™ 9-PLUG-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806011509), received between Jul 1, 2022 and Dec 4, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Migration or Expulsion of Device; Separation Problem; Migration or Expulsion of Device; Separation Problem

  IT WAS REPORTED THAT ON 10 NOVEMBER 2023, A 16MM AMPLATZER VASCULAR PLUG WAS SELECTED FOR AN IMPLANT FOR EMBOLIZATION OF SUBCLAVIAN ARTERY AS PART OF COMPLEX THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE. PLUG WAS UNSHEATHED TO SUBCLAVIAN ARTERY VIA BRACHIAL PUNCTURE AND 6F SHEATH. SIZING/POSITIONING CONFIRMED, PLUG WELL APPOSED TO VESSEL. PUSHER WIRE TURNED COUNTERCLOCKWISE MANY TIMES TO DETACH, (COULD NOT RECALL HOW MANY TIMES THE PUSHER WAS TURNED) BUT PLUG WOULD NOT DETACH. AFTER SOME MOVEMENT BACK AND FORTH WITH THE PUSHER WIRE, PLUG DETACHED. ON LATER IMAGING (6 WEEK FOLLOW UP SCAN) IT APPEARS THE PLUG HAS PARTIALLY PUSHED THROUGH SUBCLAVIAN ARTERY. PATIENT HAS BEEN DISCHARGED AND NO FURTHER COMMENTS FROM SURGEON AROUND THE DEVICE OR CONCERNS FOR THE PATIENT EXCEPT TO REPORT UNUSUAL FINDINGS ON POST IMAGING.

  Patient problems: Insufficient Information

  MAUDE report 18256695 ↗
• MalfunctionOct 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, ¿INTERMEDIATE AND LONG-TERM FOLLOW-UP OF TRANSCATHETER CLOSURE OF CONGENITAL CORONARY CAMERAL FISTULAS IN INFANTS AND CHILDREN: EXPERIENCE FROM A SINGLE CENTER¿, WAS REVIEWED.THE ARTICLE PRESENTED A CASE STUDY OF A 4-YEAR-OLD, 15KG PATIENT WITH A CORONARY CAMERAL FISTULA AND CORONARY ARTERY ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 16MM AMPLATZER VASCULAR PLUG WAS CHOSEN FOR IMPLANT TO OCCLUDE A CORONARY CAMERAL FISTULA. IT WAS REPORTED 3 MONTHS POST-PROCEDURE, A LARGE RESIDUAL SHUNT WAS NOTED. THERE WAS NO TREATMENT REPORTED. THE ARTICLE CONCLUDED THAT TCC OF CCFS IN INFANTS AND CHILDREN APPEARS TO BE EFFECTIVE AND IS ASSOCIATED WITH A RELATIVELY LOW COMPLICATION RATE. LARGE CCFS AND GIANT CORONARY ARTERY ANEURYSMS (CAAS) REPRESENT A HIGHER RISK OF BOTH ACUTE AND INTERMEDIATE AND LONG-TERM ADVERSE EVENTS AFTER CLOSURE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ZHIWEI ZHANG, DEPARTMENT OF PEDIATRIC CARDIOLOGY, GUANGDONG CARDIOVASCULAR INSTITUTE, GUANGDONG PROVINCIAL PEOPLE¿S HOSPITAL (GUANGDONG ACADEMY OF MEDICAL SCIENCES), SOUTHERN MEDICAL UNIVERSITY, GUANGDONG PROVINCIAL KEY LABORATORY OF SOUTH CHINA STRUCTURAL HEART DISEASE, GUANGZHOU, 510100, CHINA, WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908661 ↗
• InjuryJul 1, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 16MM AMPLATZER VASCULAR PLUG WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. THE DEVICE WAS SUCCESSFULLY IMPLANTED. A SECOND UNKNOWN PLUG WAS PLACED PROXIMAL TO THE 16MM AMPLATZER VASCULAR PLUG. THE UNKNOWN PLUG BUMPED INTO THE 16MM AMPLATZER ,CAUSING IT TO MIGRATE FROM THE RIGHT HEPATIC VEIN AND ENDED UP IN THE RIGHT VENTRICLE. THE AMPLATZER DEVICE SUCCESSFULLY RETRIEVED VIA JUGULAR ACCESS & SNARE. THE UNKNOWN PLUG REMAINED IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14891728 ↗