Amplatzer™ 9-AVP2-003Recalls & reported problems
St. Jude Medical, Inc. · Vascular Plug II · Class 2 · Implant
All models of Amplatzer (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806010342), received between Feb 20, 2024 and Jan 19, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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 Advance1
- Difficult to Fold, Unfold or Collapse1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2026Premature Separation
MalfunctionSep 11, 2024Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT ON 24 JUNE 2024, A 3MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE PLUG COULD NOT PASS THROUGH. A NEW 3MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191595 ↗MalfunctionFeb 20, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT ON (B)(6) 2024, A 3MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN FOR IMPLANT. THE PLUG WAS PUSHED OUT OF THE DELIVERY SYSTEM AND THE END WAS FOUND TO BE DEFORMED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. A REPLACEMENT 3MM AMPLATZER VASCULAR PLUG 2 WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743576 ↗
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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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