AxiumTM PC-9-30-HELIXRecalls & reported problems
Micro Therapeutics, Inc. · COIL PC-9-30-HELIX V04 · Class 2 · Implant
All models of AxiumTM (139)
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 00847536033139), received between Apr 27, 2022 and Apr 27, 2022 — 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 16, 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.
MalfunctionApr 27, 2022Separation Failure; Separation Failure
MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL FAILED TO DETACH. THE PATIENT WAS BEING TREATED FOR NEUROVASCULAR ABNORMALITIES THAT WERE NOT IN A ELOQUENT REGION. VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COILS CANNOT DETACHED EVEN CHANGE NEW DETACHER SO CUSTOMER DECIDED TO REMOVE THE COIL AND REPLACE WITH NEW COIL INSTEAD. THE PHYSICIAN ATTEMPTED TO DETACH WITH THE INSTANT DETACHER 3 TIMES. THEY TRIED ANOTHER DETACHER TWO TIMES. NO MANUAL ATTEMPT TO DETACH WAS MADE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14221938 ↗
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page