AMPLATZER™ 9-ASD-010Recalls & 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 05415067019189), received between Mar 29, 2019 and Mar 29, 2019 — 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
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2019Unintended Movement; Unintended Movement
ON (B)(6) 2019, A 7MM AMPLATZER SEPTAL OCCLUDERS (ASO) AND A 9MM ASO WERE NOT IMPLANTED DUE TO MIS-SIZING. A THIRD 10MM ASO WAS SELECTED FOR IMPLANT. AFTER RELEASING THE DEVICE, THE ASO EMBOLIZED FROM THE DELIVERY CABLE TO THE PULMONARY ARTERY. THE DEVICE WAS RETRIEVED BY A SNARE AND THE PATIENT WAS DISCHARGED AND IS REPORTED TO BE STABLE. AN ADDITIONAL PROCEDURE IS PLANNED TO CLOSE THE ASD IN THE FUTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8463901 ↗
Other Transcatheter septal occluder devices
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder294 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death213 reports
- Amplatzer™ Talisman™ 9-PFO-3025St. Jude Medical, Inc. · Transcatheter septal occluder1 death193 reports
- GORE CARDIOFORM Septal Occluder GSX0030AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder1 recall143 reports
- Amplatzer™ 9-ASD-MF-025St. Jude Medical, Inc. · Transcatheter septal occluder1 death183 reports
- Amplatzer™ PFO OccluderSt. Jude Medical, Inc. · Transcatheter septal occluder1 death153 reports
- Amplatzer™ 9-ASD-MF-030St. Jude Medical, Inc. · Transcatheter septal occluder149 reports
- Amplatzer™ Talisman™ 9-PFO-2518St. Jude Medical, Inc. · Transcatheter septal occluder139 reports
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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