Amplatzer™ 9-VSD-MUSC-004Recalls & reported problems
St. Jude Medical, Inc. · Muscular VSD Occluder · Class 3 · Implant
All models of Amplatzer (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811806011783), received between Feb 13, 2019 and May 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Separation1
- Difficult to Fold, Unfold or Collapse1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT ON 23 APRIL 2025, A 4MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F NON-ABBOTT DELIVERY SHEATH. DURING PROCEDURE, ONE OF THE DISCS DID NOT TAKE PROPER SHAPE AND DEFORMED WITH A COBRA SHAPE. THE SHAPE WAS ATTEMPTED TO BE CORRECTED MULTIPLE TIMES, BUT THE DEFORMATION PERSISTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND NO DEVICE WAS ULTIMATELY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22038214 ↗MalfunctionFeb 13, 2019Difficult or Delayed Separation; Difficult or Delayed Separation
A 4 MM AMPLATZER MUSCULAR VSD OCCLUDER (MUSCVSD) WAS DEPLOYED THROUGH A 5F AMPLATZER TORQVUE 180 DELIVERY SYSTEM (DTV180) BUT WOULD NOT RELEASE FROM THE DELIVERY CABLE. THE MUSCVSD WAS RETRACTED BACK IN THE SHEATH AND REMOVED FROM THE PATIENT. A SECOND 4 MM MUSCVSD (LOT: 5414451) WAS SUCCESSFULLY IMPLANTED USING A SECOND 5F DTV180 (LOT: 5984524). PATIENT WEIGHT WAS NOT PROVIDED BY THE HEALTHCARE PROVIDER AND WILL NOT BE MADE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8336868 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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