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Amplatzer™ 9-ASD-014Recalls & reported problems

Aga Medical Corporation · Septal Occluder · Class 3 · 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 05415067019226), received between Dec 6, 2018 and Dec 6, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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

  • Unintended Movement1

Patient problems

  • Blood Loss1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 6, 2018Unintended Movement; Unintended Movement

    ON (B)(6) 2018, A 14MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. AT THE END OF PROCEDURE, BLOOD WAS NOTICED IN THE ENDOTRACHEAL BREATHING TUBE; HOWEVER, ONCE THE BLEEDING RESOLVED THE PATIENT WAS EXTUBATED SUCCESSFULLY. POST-PROCEDURE CT SCAN SHOWED THE DEVICE HAD EMBOLIZED TO THE ABDOMINAL AORTA. ON (B)(6) 2018, THE OCCLUDER WAS SNARED THROUGH THE FEMORAL ARTERY WITHOUT ANY COMPLICATIONS. THE PATIENT IS SCHEDULED FOR PERCUTANEOUS CLOSURE OF THE ASD ON (B)(6) 2018. THE PATIENT IS REPORTED TO BE STABLE.

    Patient problems: Blood Loss

    MAUDE report 8139108 ↗

Other Transcatheter septal occluder devices

All Transcatheter septal occluder devices →

Sources and updates

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