Amplatzer™ Septal Occluder (REF 9-ASD-005)Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811806010021), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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
- Difficult to Fold, Unfold or Collapse1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT A 5MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024. DURING THE PROCEDURE THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 5MM AMPLATZER SEPTAL OCCLUDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950519 ↗
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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