Amplatzer™ 9-ASD-034Recalls & reported problems
Aga Medical Corporation · Septal Occluder · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067019356), received between Mar 29, 2019 and Jun 30, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
- Positioning Problem1
Patient problems
- Arrhythmia1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
ON (B)(6) 2020 A HEALTHCARE PROVIDER EMAILED STATING THAT HE HAD A 34MMASO OCCLUDER THAT WAS DEFECTIVE. THE USER REPORTS THE OCCLUDE CAME OFF OF THE CABLE WITHOUT ANY MANIPULATION. ADDITIONAL INFORMATION WAS REQUESTED ASKING FURTHER QUESTIONS REGARDING THE STATEMENT, THE FOLLOWING RESPONSE WAS RECEIVED: PER DR. (B)(6), THE PHYSICIAN PERFORMING THE PROCEDURE REPORTS. A 34 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND DETERMINED TO BE DEFECTIVE AND IT WAS DEEMED TO BE TOO LARGE (SO WE USED A SMALLER ONE). A REPLACEMENT WAS CHOSEN, A 30MM AMPLATZER SEPTAL OCCLUDER. ACCORDING TO THE IMPLANTING PHYSICIAN, THE PATIENT DEVELOPED SOME BRIEF RUNS OF VT. THE SITE REPORTS THE PATIENT TO BE IN STABLE CONDITION. WHAT HAPPENED THAT THE DEVICE IS BEING CONSIDERED AS DEFECTIVE? CAME OFF THE CABLE W/O ANY MANIPULATION.
Patient problems: Arrhythmia
MAUDE report 10213635 ↗InjuryMar 29, 2019Positioning Problem; Positioning Problem
ON (B)(6) 2019, A 34MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. AFTER RELEASE, THE DEVICE DID NOT APPEAR POSITIONED CORRECTLY IN THE SEPTUM. THE USER ATTEMPTED TO SNARE AND REMOVE THE DEVICE TO NO SUCCESS. AS THE ATTEMPT WAS UNSUCCESSFUL, THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TAKEN TO SURGERY WHERE THE DEVICE WAS REMOVED AND THE SEPTAL DEFECT WAS CLOSED. POST-OPERATIVELY, THE PATIENT IS REPORTED TO BE STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8465844 ↗
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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