Micro Plug Set 90001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00867966000112), received between Mar 13, 2024 and May 26, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Migration

  THE CUSTOMER REPORTS THAT WHILE IN USE IN AN ANIMAL LAB, THE SIEGE PLUG WAS DELIVERED TO THE EMBOLIZATION LOCATION BUT WAS NOTED TO MIGRATE A FEW CENTIMETERS DISTALLY AFTER DETACHMENT. PACKED COILS WERE THEN EMBOLIZED AND ALSO MIGRATED DISTALLY AFTER DETACHMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280139 ↗
• InjuryApr 16, 2026Gradient Increase

  THE CUSTOMER REPORTS THAT WHEN ATTEMPTING TO CLOSE THE PATENT DUCTUS ARTERIOSUS (PDA) WITH A 5 MILLIMETER DEVICE, IT SEEMED OVERSIZED AND WAS RECAPTURED AND REPLACED WITH A 4 MILLIMETER DEVICE. LATER FOLLOW-UP IMAGING SHOWED A GRADIENT WAS IN THE AORTA. THE DECISION WAS MADE TO SURGICALLY REMOVE THE DEVICE. THE PATIENT IS DOING FINE. NO ADDITIONAL DETAILS WERE PROVIDED. PER DR. (B)(6): LATE AORTIC PROTRUSION REQUIRING REMOVAL OF THE DEVICE SURGICALLY. DEVICE WAS IMPLANTED BY DR. (B)(6). BASED ON A BRIEF CONVERSATION WITH DR. (B)(6) ON 2/16/24, DR. (B)(6) WAS USING THE MICRO PLUG SET TO TREAT A PATIENT WITH PDA. HE INITIALLY ATTEMPTED TO CLOSE THE PDA WITH A 5 MM (KA90002) DEVICE - IT SEEMED OVERSIZED AND WAS RECAPTURED AND REPLACED WITH A 4 MM (KA90001) DEVICE. AT LATER FOLLOW-UP IMAGING, A GRADIENT WAS NOTED IN THE AORTA. THE DECISION WAS MADE TO SURGICALLY REMOVE THE DEVICE. THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901269 ↗
• MalfunctionApr 15, 2026Migration

  THE CUSTOMER REPORTS THAT THE SIEGE PLUG WAS DELIVERED TO THE EMBOLIZATION LOCATION BUT WAS NOTED TO MIGRATE A FEW CENTIMETERS DISTALLY AFTER DETACHMENT. PACKED COILS WERE THEN EMBOLIZED AND ALSO MIGRATED DISTALLY AFTER DETACHMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO REPORTED HARM TO THE PATIENT. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887011 ↗
• InjuryMar 13, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN ALLEGES THAT A PREEMIE PATIENT DIAGNOSED WITH A PATENT DUCTUS ARTERIOSUS (PDA) UNDERWENT A [OFF-LABEL USE] PDA CLOSURE PROCEDURE ON (B)(6) 2022. A 5MM CLOSURE DEVICE WAS INITIALLY PLACED BUT HAD NOT BEEN FULLY DEPLOYED BECAUSE THE 5MM DEVICE WAS CAUSING LEFT PULMONARY ARTERY [LPA] NARROWING. THE 5MM DEVICE WAS EXCHANGED FOR A 4MM CLOSURE DEVICE THAT WAS SUCCESSFULLY DEPLOYED WITHIN THE PATIENT. THE FOLLOW-UP ECHO STUDIES LOOKED GOOD INITIALLY AND THEN 48 HOURS AFTER THE PROCEDURE NO RESIDUAL SHUNT, ARCH OBSTRUCTION, OR LPA OBSTRUCTION WAS NOTED. DURING A FOLLOW-UP APPOINTMENT POST-PDA CLOSURE PROCEDURE, A NARROWING WITHIN THE PATIENT'S ARCH HAD BEEN IDENTIFIED. AFTER OBSERVING THE PATIENT FOR A FEW MONTHS, THE DECISION WAS MADE TO SURGICALLY REMOVE THE DEVICE DUE TO AN AORTIC ARCH GRADIANT, IN (B)(6) 2023. SURGICAL REMOVAL WAS SUCCESSFUL, AND 16 MONTHS POST INITIAL PDA CLOSURE THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895021 ↗