Axium QC-16-40-HELIXRecalls & reported problems
Micro Therapeutics, Inc. · QC-16-40-HELIX BARE AXIUM HELIX COIL · Class 2 · Implant
All models of Axium (28)
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 00836462010246), received between Dec 13, 2018 and Dec 13, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED REPORT THAT THE COIL ENCOUNTERED RESISTANCE WITHIN MEDTRONIC CATHETER HUB. THE COIL WAS ABLE TO EXIT THE SHEATH SMOOTHLY. A NEW SAME SIZE COIL WAS USED TO TREAT THE PATIENT WITH THE SAME CATHETER. NO PATIENT INJURY WAS REPORTED. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE IMPLANT COIL WAS DETACHED AND MISSING FROM THE PUSHWIRE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8161943 ↗
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
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
- 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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