IMPEDE-FX Embolization Plug IMP-FX-06Recalls & reported problems
Shape Memory Medical Inc. · IMPEDE-FX Embolization Plug, 6mm · Class 2
All models of IMPEDE-FX Embolization Plug (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810041650030), received between Nov 19, 2021 and Nov 10, 2023 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
- Insufficient Device Problem Information1
- Positioning Failure1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Dyspnea1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2023Insufficient Device Problem Information; Activation Failure; Insufficient Device Problem Information; Activation Failure
AN IMP-07 AND IMP-FX-06 DEVICE WERE USED IN A CASE IN (B)(6) TO TREAT AN AVM ON (B)(6) 2023. EMBOLIZATION WAS CONFIRMED AT THE END OF THE PROCEDURE. DURING A FOLLOW-UP VISIT ON (B)(6) 2024, IT WAS FOUND THAT THE VESSEL HAD RECANALIZED WHICH REQUIRED RE-INTERVENTION TO DELIVER ADDITIONAL EMBOLIC DEVICES (I.E., COOK NESTER COILS). THE PATIENT STATUS WAS REPORT STABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 18116437 ↗MalfunctionNov 19, 2021Positioning Failure; Positioning Failure
A PATIENT PRESENTED WITH A PAVM (2.6 MM IN DIAMETER) WHICH HAD RECANALIZED AFTER PREVIOUSLY BEING EMBOLIZED USING COILS (NOT MANUFACTURED BY SMM). AN IMP-FX-06 DEVICE WAS CHOSEN FOR DELIVERY TO A SITE PROXIMAL TO THE PREVIOUSLY IMPLANTED COILS WITH NO SIDE BRANCHES IN THE VICINITY. DURING 4F MP CATHETER WITHDRAWAL, THE IMP-FX PLUG MIGRATED FROM THE SUB-SEGMENTAL BRANCH WHERE IT WAS DEPLOYED TO ANOTHER SUB-SUBSEGMENTAL BRANCH. IT WAS REPORTED THE PATIENT HAD EXPERIENCED DYSPNEA ONCE A DAY OR TWO AFTER THE PROCEDURE, BUT NOW HAS A STABLE STATUS.
Patient problems: Dyspnea
MAUDE report 12844887 ↗
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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