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AxiumTM APB-5-10-HX-SSRecalls & reported problems

Micro Therapeutics, Inc. · APB-5-10-HX-SS PRIME BARE AXIUM · Class 2 · Implant

All models of AxiumTM (139)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536008205), received between Apr 4, 2019 and Aug 12, 2019 — classified as 1 death, 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

  • Adverse Event Without Identified Device or Use Problem1
  • Detachment of Device or Device Component1

Patient problems

  • Death1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THE COILS WERE REMOVED FROM THE PATIENT ANATOMY. THE COILS WERE REPOSITIONED. THERE WAS NO FICTION OR DIFFICULTY. THE COILS WERE NOT ATTEMPTED TO BE DETACHED. THE PUSHWIRES WERE NOT ROTATED. A SENT WAS USED TO COMPLETE THE PROCEDURE. THIS EVENT OCCURRED DURING THE TREATMENT OF A RUPTURED SACCULAR ACME 4MM. YOUNG ADULT (OVER 18 AND UNDER 60).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8886265 ↗
  • 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 8483814 ↗

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 · Terminated
    Axium 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 · Terminated
    Axium 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

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page