IMPEDE-FX Embolization Plug IMP-FX-08Recalls & reported problems
Shape Memory Medical Inc. · IMPEDE-FX Embolization Plug, 8mm · Class 2
All models of IMPEDE-FX Embolization Plug (3)
Data updated Oct 16, 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 00810041650047), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2021Positioning Failure; Positioning Failure
A COMBINATION OF IMPEDE AND IMPEDE-FX DEVICES WERE USED TO TREAT A PAVM. AFTER THE PHYSICIAN DELIVERED AN IMPEDE AND AN IMPEDE-FX DEVICE TO THE FIRST FEEDER VESSEL (5.7 MM DIAMETER), RESIDUAL SAC FLOW COMING FROM A SECOND FEEDER VESSEL WAS OBSERVED. THE PHYSICIAN THEN TRIED DEPLOYING AN IMP-FX-08 TO OCCLUDE THIS VESSEL, HOWEVER, POSSIBLY DUE TO HIGH FLOW IN THE VICINITY, THE DEVICE MIGRATED TO ANOTHER VESSEL. THEREAFTER, HAVING FOUND NO PLUG IN THE PATIENT'S CAROTID, THE CASE WAS COMPLETED USING ANOTHER IMPEDE DEVICE AND A CT SCAN PERFORMED AFTERWARDS LOCATED THE MISSING IMP-FX-08 DEVICE IN THE PATIENT'S HAND. AS OF (B)(6) 2021, ALTHOUGH THE PATIENT REPORTED NO COMPLAINTS, IT WAS DECIDED THAT THE PLUG WOULD BE REMOVED VIA PLASTIC SURGERY DUE TO THE APPEARANCE OF A RED SPOT ON THE SKIN OF THE PATIENT'S PALM.
Patient problems: Skin Discoloration
MAUDE report 12783717 ↗
Other Device, Vascular, For Promoting Embolization devices
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- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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