Axium Prime Detachable Coil System APB-4-10-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536038547), received between Aug 16, 2022 and Dec 2, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE NON-DETACHMENT WAS UNKNOWN. PRIOR TO NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20822445 ↗
• MalfunctionApr 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON COIL WAS IMPLANTED BEFORE AND AFTER THE MALFUNCTIONED COIL. THE DISTAL PART OF THE COIL WAS IN THE ANEURYSM, THE PROXIMAL PART WAS IN THE PARENT VESSEL. NO SURGICAL OR ADDITIONAL DEVICE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832272 ↗
• MalfunctionSep 24, 2022Separation Failure; Material Deformation; Separation Failure; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ANOMALIES WERE NOTED NEITHER DURING THE INSERTION NOR DELIVERY OF THE COIL. IT WAS OBSERVED THAT THERE WAS DAMAGE TO THE PUSHWIRE NEAR TO THE MANUAL MARKER DETACHMENT POINT. THE PATIENT WAS UNDERGOING TREATMENT FOR AN APEX LEFT OBLONG ANEURYSM LOCATED IN THE A1 SEGMENT. THE ANEURYSM SIZE WAS 5MM X 2MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480225 ↗
• MalfunctionAug 16, 2022Break; Material Deformation; Break; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PUSHER WAS KINKED/BROKEN. AFTER THE INTRAOPERATIVE CORDIS8F GUIDE CATHETER WAS IN PLACE, AND AFTER CHOOSING STRYKER SYNCHRO-14 GUIDE WIRE WITH THE ECHELON 10 MICROCATHETER IN PLACE. THE FIRST COIL WAS PUSHED THROUGH SMOOTHLY TO THE MICROCATHETER UNTIL THE ANEURYSM WAS DETACHED NORMALLY. THE SECOND COIL WAS SMOOTHLY PUSHED TO THE MICROCATHETER UNTIL THE ANEURYSM WAS DETACHED NORMALLY. WHEN THE PEIME APB-4-10-HX-SS WAS SELECTED, IT WAS SMOOTHLY PUSHED TO THE MICROCATHETER UNTIL THE ANEURYSM BUT WHEN THE PROXIMAL DETACHMENT POINT WAS DETACHED AND THE PUSH ROD WAS DIRECTLY BROKEN. WHEN DETACHING THE SECOND DETACHMENT POINT, THE PUSH ROD WAS ALSO DIRECTLY BROKEN. FINALLY, THE WIRE WAS PULLED OUT OF THE COIL BY A HEMOSTATIC FORCEPS, WHICH COULD BE DETACHED. THE COIL WAS REPLACED AND THE NEW COIL WAS SMOOTHLY PUSHED TO THE MICROCATHETER UNTIL THE ANEURYSM WAS DETACHED NORMALLY. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE LOCATION WAS AT THE PUSHWIRE PROXIMAL SEGMENT. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY. THE ANEURYSM WAS RUPTURED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234721 ↗

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 · 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
• 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