Amplatzer™ Vascular Plug 4 (REF 9-AVP038-004)Recalls & reported problems
Aga Medical Corporation · Vascular Plug 4 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806012346), received between Oct 12, 2021 and Nov 8, 2023 — classified as 2 injuries, 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
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Fold, Unfold or Collapse1
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Renal Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT A 4MM AMPLATZER VASCULAR PLUG IV WAS SELECTED FOR IMPLANT ON 05 (B)(6) 2023 TO TREAT CARDIAC MALFORMATION. DURING IMPLANT, THE DEVICE TOOK ON A DEFORMED SHAPE, WITH THE DISTAL PART OF THE PLUG WIDER THAN THE PROXIMAL PART. IT WAS OBSERVED THE SECOND LOBE WAS UNABLE TO DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY SYSTEM. IT WAS NOTED THAT THE DEVICE WAS REPLACED WITH A NEW UNKNOWN DEVICE. THE INTERVENTION TIME WAS REPORTED TO BE LESS THAN 30 MINUTES. THERE WAS NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093357 ↗InjuryJun 26, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT ON (B)(6) 2023, A 4MM AMPLATZER VASCULAR PLUG IV WAS IMPLANTED. AFTER THE PROCEDURE, THE 4MM AMPLATZER VASCULAR PLUG IV HAD MIGRATED. THE VESSEL THEY TRIED TO EMBOLIZE WAS MEASURED AS 3.59MM. THE INSTRUCTIONS INSIDE THE PACKET SAID TO USE A 4MM PLUG. WHEN THEY CHECKED ONLINE, IT SAID TO USE A 5MM PLUG. THE DEVICE WAS SNARED TO RESOLVE THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17204343 ↗InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, A 4MM AMPLATZER VASCULAR PLUG 4 AND A 6MM AMPLATZER VASCULAR PLUG 4 WERE IMPLANTED IN THE LEFT RENAL ARTERY. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ACUTE STOMACH PAIN. COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED, WHICH SHOWED NEW ONSET RENAL INFARCTION. NO TREATMENT WAS REQUIRED AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.
Patient problems: Renal Impairment
MAUDE report 12619049 ↗
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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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