AMPLATZER™ 9-AVP2-004Recalls & reported problems
Aga Medical Corporation · Vascular Plug II · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806010359), received between Jun 11, 2018 and Dec 13, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Migration1
- Patient Device Interaction Problem1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT ON (B)(6) 2023, A 4MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, A NON-ABBOTT DELIVERY CATHETER WERE IN PLACE. THE PLUG WAS IMPLANTED, AND THE LEAK WAS OBSERVED 3 MINUTES LATER. THE CONTRAST AGENT STILL PASSES THROUGH THE TARGET VESSEL DUE TO POOR ADHERENCE. THE SIZE OF THE VESSEL PLUG IS NOT SUITABLE FOR THE SHAPE OF THE ARTERIAL DUCT. SO THE PHYSICIAN REPLACED WITH A NON-ABBOTT DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE, NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18322634 ↗InjuryMar 6, 2019Migration; Migration
RELATED MANUFACTURER NUMBER: 2135147-2019-00064. ON AN UNKNOWN DATE, AN 4 AMPLATZER VASCULAR PLUG II SELECTED FOR IMPLANT. THE DEVICE WAS DEPLOYED, BUT MIGRATED AFTER DEPLOYMENT. AN 6MM AMPLATZER VASCULAR PLUG II WAS THEN SELECTED BUT THAT DEVICE ALSO MIGRATED. AN 8MM AMPLATZER VASCULAR PLUG II WAS THEN SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8397525 ↗InjuryJun 11, 2018Unintended Movement; Unintended Movement
IN (B)(6) 2018, 4 MM AMPLATZER VASCULAR PLUG II WAS IMPLANTED IN THE PATIENT DUCTUS ARTERIOUS. THE DAY AFTER IMPLANT, THE PATIENT PRESENTED WITH SYMPTOMS OF DEVICE EMBOLIZATION. ON (B)(6) 2018, PERCUTANEOUS RETRIEVAL OF THE DEVICE WAS PERFORMED AND REPLACED WITH A 6 MM AMPLATZER DUCT OCCLUDER II (LOT NUMBER: 6277108). THE PATIENT IS REPORTED TO BE STABLE. THE USER BELIEVES THEY UNDERSIZED THE DEVICE.
Patient problems: No Information
MAUDE report 7586952 ↗
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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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