AMPLATZER™ 9-PLUG-006Recalls & reported problems
Aga Medical Corporation · Vascular Plug · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811806011455), received between May 25, 2022 and May 25, 2022 — classified as 1 injury.
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
Device problems
- Migration or Expulsion of Device1
Patient problems
- Aortic Valve Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
AN ARTICLE FROM THE MEDICAL CONFERENCE ABSTRACT MAGAZINE FOR (B)(6) SOCIETY OF CONGENITAL INTERVENTIONAL CARDIOLOGY, WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE OF A (B)(6) FEMALE WHO HAD A NON -ABBOTT DEVICE IMPLANTED IN THE VENOUS DUCT AT BIRTH AND HAD A HISTORY OF ASPLENIA, SINGLE VENTRICLE, AORTIC STENOSIS, COARCTATION OF AORTA AND COMPLICATED BY TOTAL ANOMALOUS PULMONARY VENOUS CONNECTION (TAPVC) IN ORDER TO POSTPONE THE TIMING OF SURGERY. BILATERAL PULMONARY ARTERIAL BANDING WAS PERFORMED WHEN THE PATIENT WAS (B)(6). TAPVC REPAIR WAS CONDUCTED AT 3 MONTH AFTER THE BIRTH. TWO WEEK AFTER, NORWOOD SURGERY AND GLENN SURGERY WERE PERFORMED. RESIDUAL BLOOD FLOW WAS CONFIRMED WITHIN THE STENT. DECREASING SATURATION OF OXYGEN WAS OBSERVED DUE TO HEPATOPULMONARY SYNDROME. PRIOR TO FONTAN SURGERY, IT WAS DECIDED TO EMBOLIZE THE BLOOD FLOW INSIDE THE STENT BY AMPLATZER VASCULAR PLUG (AVP)WHEN THE PATIENT WAS (B)(6). A 6MM AMPLATZER VASCULAR PLUG WAS IMPLANTED, ONE MINUTE AFTER, THE DEVICE MIGRATED INTO THE DESCENDING ARTERY WAS REMOVED BY A NON -ABBOTT DEVICE. THE VENOUS DUCT WAS SURGICALLY SEMI-SUTURED AND ACHIEVED COMPLETE CLOSURE SPONTANEOUSLY. AFTER THAT, FONTAN SURGERY WAS U
Patient problems: Aortic Valve Stenosis
MAUDE report 14493544 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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