AMPLATZER™ 9-PLUG-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806011486), received between Nov 10, 2022 and Dec 4, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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.

• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER VASCULAR PLUG WAS IMPLANTED IN THE LEFT SUBCLAVIAN ARTERY (LSA) FOR THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR) WITH A 8F NON-ABBOTT GUIDING CATHETER. IT WAS REPORTED THE VESSEL DIAMETER WAS 8MM AND ECHOCARDIOGRAPHY CONFIRMED SUCCESSFUL IMPLANT WITH COMPLETE OCCLUSION OF BLOOD FLOW. AFTER 1 MONTH POST-PROCEDURE ON (B)(6) 2023, THE PATIENT EXPERIENCED PERSISTENT CHEST DISCOMFORT. IT WAS LATER REPORTED THAT ON (B)(6) 2023, AN ECHOCARDIOGRAPHY REVEALED AN ENDOLEAK OF BLOOD FLOW IN THE LSA. IT WAS THEN REPORTED ON (B)(6) 2023, A DECISION WAS MADE TO ADDITIONALLY IMPLANT A NON-ABBOTT DEVICE IN THE LSA. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Aneurysm; Angina

  MAUDE report 18256836 ↗
• InjuryAug 14, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ARTICLE, ¿A CHALLENGING INTERVENTIONAL PROCEDURE: TRANSCATHETER CLOSURE OF TUBULAR PATENT DUCTUS ARTERIOSUS IN PATIENTS WITH PULMONARY HYPERTENSION¿, WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF AN 1-YEAR-OLD, 6.6KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 7.9MM, AMPULLA DIAMETER = 7.8MM, DUCTAL LENGTH = 12.9MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 12MM AMPLATZER VASCULAR PLUG I WAS CHOSEN FOR IMPLANT TO OCCLUDE A PDA. AFTER IMPLANT, IT WAS NOTED THE DEVICE HAD EMBOLIZED INTO THE PULMONARY ARTERY. A DECISION WAS MADE TO RETRIEVE AND EXPLANT THE EMBOLIZED DEVICE VIA TRANSCATHETER SNARE. A NEW 14MM AMPLATZER VASCULAR PLUG I WAS CHOSEN FOR IMPLANT. THE SECOND DEVICE ALSO EMBOLIZED INTO THE PULMONARY ARTERY AFTER RELEASE AND WAS ALSO EXPLANTED VIA TRANSCATHETER SNARE. A DECISION WAS MADE TO ADMIT THE PATIENT FOR SURGICAL LIGATION OF THE PDA. [THE PRIMARY AND CORRESPONDING AUTHOR IS ILKER KEMAL YUCEL, DEPARTMENT OF PEDIATRIC CARDIOLOGY, UNIVERSITY OF HEALTH SCIENCES DR. SIYAMI ERSEK THORACIC AND CARDIOVASCULAR SURGERY TRAINING AND RESEARCH HOSPITAL, ISTANBUL, TURKEY, [email protected]]. PERIPROCEDURAL COMPLICATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540973 ↗
• MalfunctionNov 10, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 12MM AMPLATZER VASCULAR PLUG WAS SELECTED FOR IMPLANTATION USING A 6F NON-ABBOTT SHEATH. DURING THE PROCEDURE, THE DEVICE WAS RE-SHEATHED SEVERAL TIMES. DURING THE RE-SHEATHING, THE DEVICE DETACHED INSIDE THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED FROM PATIENT ANATOMY. THE PHYSICIAN WAS UNSUCCESSFUL AT RE-ATTACHING THE DEVICE TO THE DELIVERY CABLE. 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 15775990 ↗