AxiumTM NC-3-4-HELIXRecalls & reported problems
Micro Therapeutics, Inc. · NC-3-4-HELIX NYLON AXIUM 3MM X 4CM · 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536013162), received between Apr 4, 2019 and Apr 4, 2019 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER COILING. THE PATIENT PRESENTED WITH HEMORRHAGE. THE PATIENT HAD A RUPTURED, SACCULAR ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT COILING IN ORDER TO IMPROVE THE SITUATION. THE PATIENT UNDERWENT IMPLANTATION OF 13 COILS INCLUDING 9 MEDTRONIC COILS. THE PATIENT REPORTEDLY PASSED AWAY POST-PROCEDURE DUE TO THE MASSIVE HEMORRHAGE.
Patient problems: Death
MAUDE report 8483673 ↗
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-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
- 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
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 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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