AMPLATZER™ 9-PLUG-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811806011479), received between Mar 2, 2023 and Mar 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 10MM AMPLATZER VASCULAR PLUG WAS CHOSEN FOR A ENDOVASCULAR AORTIC REPAIR (EVAR) CASE FOR INTERNAL ILIAC ARTERY EMBOLIZATION USING A 6F NON-ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, THE DELIVERY SHEATH WAS ENGAGED IN THE CONTRALATERAL INTERNAL ILIAC ARTERY VIA THE LEFT FEMORAL APPROACH. WHILE DELIVERING THE DEVICE, THERE WAS SOME RESISTANCE DUE TO SEVERE TORTUOSITY. ALTHOUGH IT SEEMED POSSIBLE TO DELIVER, THE PUSHER WIRE WAS UNINTENTIONALLY ROTATED COUNTERCLOCKWISE DURING DELIVERY, CAUSING IT TO DETACH INSIDE THE CATHETER. THE CATHETER WAS REMOVED AND RETRIEVED. ANOTHER ATTEMPT TO MOUNT IT WAS UNSUCCESSFUL AND IT BECAME CONTAMINATED, A NEW 10MM AMPLATZER VASCULAR PLUG WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21506435 ↗
• MalfunctionMar 2, 2023Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 10MM AMPLATZER VASCULAR PLUG WAS SELECTED FOR IMPLANT USING A 6F NON-ABBOTT DELIVERY SYSTEM, WITH AN INNER DIAMETER OF 0.07 INCHES. IT WAS NOTED DURING PROCEDURE THAT THE PLUG WAS UNABLE TO BE ADVANCED. THE DECISION WAS MADE TO REMOVE THE PLUG FROM THE PATIENT'S ANATOMY. IT WAS NOTED AFTER SUCCESSFUL REMOVAL OF THE PLUG, THAT THE PLUG BECAME PREMATURELY DETACHED FROM THE DELIVERY CABLE. THE 10MM AMPLATZER VASCULAR PLUG HAD BEEN SIZED SELECTING A PLUG THAT IS 30 TO 50% LARGER THAN THE BLOOD VESSEL DIAMETER. THE PATIENT DOES NOT HAVE A TORTUOUS ANATOMY AND THE PLUG WAS NOT MISHANDLED OR DAMAGE AT ANY POINT DURING DEVICE PREPARATION. THE DECISION WAS MADE TO REPLACE THE 10MM AMPLATZER VASCULAR PLUG WITH AN UNKNOWN NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474422 ↗