AMPLATZER™ 9-ITV09F180/80Recalls & reported problems
Aga Medical Corporation · Delivery System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811806010854), received between Mar 6, 2026 and Mar 6, 2026 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Arrest1
- Cardiac Tamponade1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2026, AN UNKNOWN AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM DURING A HIGH-RISK POST-INFARCTION VENTRICULAR SEPTAL DEFECT (PIVSD) CLOSURE PROCEDURE IN A PATIENT WHO WAS IN CARDIOGENIC SHOCK SECONDARY TO POST-MI VSD. THE PATIENT HAD BEEN ON THERAPEUTIC LMWH PRIOR TO THE PROCEDURE, AND DURING THE PROCEDURE WAS RECEIVING IV HEPARIN, WITH AN ACTIVATED CLOTTING TIME OF 300 SECONDS. THE PATIENT WAS IN SINUS RHYTHM AT THE TIME OF THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR THE INTERVENTION. AS THE DELIVERY SHEATH WAS ADVANCED ACROSS THE APICAL VSD, THE SEPTAL TISSUE APPEARED EXTREMELY FRAGILE, CONSISTENT WITH FRIABLE MYOCARDIUM FOLLOWING MYOCARDIAL INFARCTION. THE PROCEDURE TEAM REPORTED NO DIFFICULTY WITH DEVICE MANIPULATION, AND THERE WERE NO ALLEGATIONS OF DEVICE MALFUNCTION AGAINST THE TORQVUE SYSTEM OR THE AMPLATZER SEPTAL OCCLUDER. THE USER ALSO CONFIRMED THAT NO ABBOTT DEVICE WAS BELIEVED TO HAVE CAUSED THE PERICARDIAL EFFUSION. DURING ADVANCEMENT OF THE SHEATH, THE TOE IMAGING TEAM EXPERIENCED DIFFICULTY OBTAINING A CLEAR VISUALIZATION
Patient problems: Cardiac Arrest; Cardiac Tamponade; Pericardial Effusion
MAUDE report 24536560 ↗
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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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