IMPEDE Embolization Plug IMP-10 (UDI B054IMP101)Recalls & reported problems
Shape Memory Medical Inc. · IMPEDE Embolization Plug 10mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B054IMP101), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Activation Failure1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2021Activation Failure; Activation Failure
THE REPORTED DATE OF THE INCIDENT IS 16-SEP-2021, ALTHOUGH THE INITIAL PROCEDURE TOOK PLACE ON (B)(6) 2021. (B)(6) 2021: A 2-DEBRANCH TEVAR WAS BEING PERFORMED USING A VALIANT CAPTIVIA STENT GRAFT FROM MEDTRONIC, AND AN IMP-10 WAS USED TO EMBOLIZE THE LEFT SUBCLAVIAN ARTERY AT THE SAME TIME. THE LEFT SUBCLAVIAN ARTERY WAS MEASURED TO BE 8-9 MM DIAMETER. THE IMP-10 WAS INTRODUCED INTO THE BODY FROM THE LEFT UPPER ARM USING AN OPTIMO GUIDING CATHETER FROM TOKAI MEDICAL PRODUCTS AND DELIVERED INTO THE TARGET SITE USING AN IMPRESS DIAGNOSTIC CATHETER FROM MERIT MEDICAL. DURING THE SURGERY IT WAS REPORTED THAT THE ANCHOR COIL WAS NOT COILED AND WAS AN IRREGULAR SHAPE WHEN THE EMBOLIZATION PLUG WAS DELIVERED. CONTRAST ENHANCED CT WAS PERFORMED AND THE SURGERY WAS COMPLETED, ALTHOUGH IT WAS NOT CONFIRMED AT THAT TIME THAT EMBOLIZATION OF THE SUBCLAVIAN WAS ACHIEVED WITH THE IMP-10 DEVICE. (B)(6) 2021: DURING THE POST-OPERATIVE EXAMINATION USING CONTRAST ENHANCED CT A TYPE II ENDOLEAK WAS FOUND FROM THE LEFT SUBCLAVIAN ARTERY (LSCA). (B)(6) 2021: IN ORDER TO TREAT THE TYPE II ENDOLEAK FOUND DURING POST-OPERATIVE FOLLOW UP, ADDITIONAL EMBOKIC COIL DEVICES (I.E. 5 INTERLOCK COILS FROM BOSTON
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12666698 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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