Micro Plug Set 90002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00867966000129), received between Jan 19, 2022 and May 8, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Premature Separation

  THE ACCOUNT ALLEGES THAT WHILE USING A 5 MM MICRO PLUG SET TO CLOSE A PDA IN A 2 KG BABY VIA FEMORAL VENOUS APPROACH, THE DEVICE PREMATURELY DISCONNECTED DURING DEPLOYMENT FROM THE DISTAL END OF THE DELIVERY CATHETER AND EMBOLIZED INTO THE DESCENDING AORTA. AN INTRODUCER SHEATH WAS PLACED IN THE FEMORAL ARTERY AND THE DEVICE WAS RETRIEVED WITH A SNARE. A NEW 5 MM MICRO PLUG SET WAS USED TO CLOSE THE PDA. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126299 ↗
• InjuryJan 19, 2022Off-Label Use; Off-Label Use

  THE ACCOUNT ALLEGES THAT DURING AN OFF LABEL MICRO PLUG IMPLANT PROCEDURE ON A (B)(6) CHILD DIAGNOSED WITH PATIENT DUCTUS ARTERIOSUS (PDA), A 5MM MICRO PLUG WAS FIRST SUCCESSFULLY DEPLOYED, MIGRATED, AND EMBOLIZED WITHIN THE PATIENT'S PULMONARY ARTERY. THE PHYSICIAN THEN SUCCESSFULLY EXTERNALIZED THE DEVICE USING A SNARE. A DIFFERENT MANUFACTURER'S DEVICE WAS THEN SUCCESSFULLY DEPLOYED IN THIS PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT. PATIENT WAS DISCHARGED AS EXPECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13290623 ↗
• InjuryJan 19, 2022Off-Label Use; Off-Label Use

  THE ACCOUNT ALLEGES THAT DURING AN OFF LABEL MICRO PLUG IMPLANT PROCEDURE ON A (B)(6) CHILD DIAGNOSED WITH PATIENT DUCTUS ARTERIOSUS (PDA), A 5MM MICRO PLUG WAS FIRST SUCCESSFULLY DEPLOYED, MIGRATED, AND EMBOLIZED WITHIN THE PATIENT'S PULMONARY ARTERY. THE PHYSICIAN THEN SUCCESSFULLY EXTERNALIZED THE DEVICE USING A SNARE. A 6 MM MICRO PLUG DEVICE WAS THEN DEPLOYED AND APPEARED TO BE STABLE. APPROXIMATELY THREE HOURS POST PROCEDURE, THE MICRO PLUG MIGRATED AND EMBOLIZED INTO THE PATIENT'S PULMONARY ARTERY. THE PHYSICIAN ATTEMPTED TO EXTERNALIZE THE DEVICE FROM THE PATIENT USING A SNARE UNSUCCESSFULLY. THE DECISION WAS MADE TO LEAVE THE DEVICE WITHIN THE PATIENT DUE TO THE FACT IT WAS NOT OBSTRUCTIVE TO BLOOD FLOW. THE PATIENT WAS THEN REFERRED TO SURGERY FOR SUCCESSFUL PDA LIGATION. THE PATIENT TOLERATED ALL PROCEDURES VERY WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT. PATIENT WAS DISCHARGED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13290622 ↗