Amplatzer™ 9-ASD-018Recalls & 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 05415067019264), received between Jun 13, 2019 and Jun 13, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
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.
InjuryJun 13, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ON (B)(6) 2019, AN 18MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE DEVICE WAS REPORTED TO HAVE EMBOLIZED. ON (B)(6) 2019, THE DEVICE WAS REMOVED FROM THE PATIENT PERCUTANEOUSLY BY SNARING AND RE-SHEATHING. THE DEFECT WAS BALLOON-SIZED TO 18MM USING A 30MM PTS SIZING BALLOON (LOT NUMBER: UNKNOWN) AND THE PHYSICIAN ATTEMPTED CLOSURE WITH A 22MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6821072) AND 26MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 5562243). BOTH DEVICES WERE REPORTED TO BE MIS-SIZED. OF NOTE, THE 26MM AMPLATZER SEPTAL OCCLUDER WAS IMPINGING ON THE MITRAL VALVE. ADDITIONALLY, THE PATIENT HAD MULTIPLS ASDS AND CHALLENGING ANATOMICAL FEATURES WHICH CAUSED THE MIS-SIZING. THE PHYSICIAN ELECTED TO ABANDONED THE PROCEDURE AND SURGICAL CLOSURE IS PLANNED FOR A FUTURE TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8697322 ↗
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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