Micro Plug Set 90003Recalls & reported problems
Ka Medical LLC · Micro Plug Set - 6mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00867966000136), received between Jan 19, 2022 and Jan 19, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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.
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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: Foreign Body In Patient
MAUDE report 13290627 ↗
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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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