AxiumTM QC-7-20-HELIXRecalls & reported problems
Micro Therapeutics, Inc. · COIL QC-7-20-HELIX V04 AXIUM · Class 2 · Implant
All models of AxiumTM (139)
Data updated Oct 18, 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 00847536029637), received between May 22, 2023 and May 22, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.
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 18, 2026.
Most reported problems
Device problems
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2023Separation Failure; Separation Failure
ADDITIONAL INFORMATION RECEIVED THAT THE LESION WAS A CAROTID CAVERNOUS FISTULA; THE DIMENSIONS ARE UNKNOWN. THE MODEL/LOT # OF THE ECHELON 10 CATHETER ARE 105-5091-150 (ECHELON-10 STRAIGHT). THERE ARE NO IMAGES OF THE DEVICE(S) AVAILABLE. THE INSTANT DETACHER LOT NUMBER IS UNKNOWN. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. THE (NON-DETACHED) COIL WAS PULLED BACK INTO THE MICROCATHETER AND SAFELY REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973889 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.
- Z-0874-2012 · Mar 1, 2010 · TerminatedAxium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
- Z-0873-2012 · Mar 1, 2010 · TerminatedAxium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab
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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
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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