Axium Detachable Coil System NC-3-4-HELIXRecalls & reported problems
Micro Therapeutics, Inc. · COIL NC-3-4-HELIX V05 · Class 2 · Implant
All models of Axium Detachable Coil System (69)
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 00847536044265), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS BEING IMPLANTED WHEN IT PREMATURELY DETACHED IN THE WRONG AREA OF THE VESSEL. THE HEALTHCARE PROVIDER (HCP) USED A STENT RETRIEVER TO THEN REMOVE THE COIL WITHOUT COMPLICATIONS WITH THE PATIENT. THERE WAS COIL SEPARATI ON/BREAK/PREMATURE DETACHMENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: Failure of Implant
MAUDE report 22853463 ↗
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
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- 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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