Axium PrimeTM APB-4-12-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536032019), received between Apr 5, 2022 and Jun 9, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AXIUM COIL DEPLOYMENT WAS UNAVAILABLE DUE TO STRONG RESISTANCE IN MICROCATHETER. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE MIDDLE OF THE CATHETER THAT OCCURRED. THE CATHETER AND COIL WERE NOT DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER . ADDITIONAL INFORMATION RECEIVED THATTHE PATIENT WAS UNDERGOING RIGHT INTERNAL CAROTID ARTERY ANEURYSM COIL EMBOLIZATION TREATMENT. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE ARE¿NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT,¿ANGIO, ETC.) AVAILABLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER PRODUCT. THE RESISTANCE WAS LOCATED IN THE MIDDLE PART OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098109 ↗
• MalfunctionJun 9, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AXIUM COIL DEPLOYMENT WAS UNAVAILABLE DUE TO STRONG RESISTANCE IN MICROCATHETER. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE MIDDLE OF THE CATHETER THAT OCCURRED. THE CATHETER AND COIL WERE NOT DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER . ADDITIONAL INFORMATION RECEIVED THATTHE PATIENT WAS UNDERGOING RIGHT INTERNAL CAROTID ARTERY ANEURYSM COIL EMBOLIZATION TREATMENT. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE ARE NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT,ANGIO, ETC.) AVAILABLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER PRODUCT. THE RESISTANCE WAS LOCATED IN THE MIDDLE PART OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098088 ↗
• MalfunctionAug 11, 2022Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED AND WAS STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT M1-M2 JUNCTION. THE MAX DIAMETER WAS 5.1MM, AND THE NECK DIAMETER WAS 3.9MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE OPERATOR PLACE THE MICROCATHETER WELL INSIDE THE ANEURYSM. THE AXIUM PRIME WAS THE FIRST COIL USED. THEY FLUSHED THE SLEEVE OF COIL AS PER THE INSTRUCTIONS FOR USE (IFU) BY PUTTING COIL SLEEVE HALF INSIDE INTO THE Y CONNECTOR AND ALLOWING SALINE FLUSH THROUGH THE COIL SLEEVE. THEY THEN INSERTED THE SLEEVE MORE INSIDE TOWARDS MICROCATHETER HUB, TIGHTENED THE RHV AS PER GUIDELINE, AND PLACED THE COIL INSIDE INTO THE ANEURYSM, SLOWLY PUSHING FORWARD WITH 80% INFLATION OF BALLOON. THE OPERATOR COULD NOT DETACH THE COIL WITH THE INSTANT DETACHER OR MANUAL DETACHMENT. THEY MADE 5-6 ATTEMPTS BUT IT WAS NOT SUCCESSFUL. WHILE PULLING THE COIL BACK INSIDE INTO MICROCATHETER THE OPERATOR NOTICED THE COMPLETE COIL WAS INSIDE BUT NOT GETTING FURTHER PULED INSIDE THE MICROCATHETER. THEY STOPPED PULLING THE COIL AND REMOVED THE ENTIRE M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210260 ↗
• MalfunctionApr 28, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT AN AXIUM COIL HAD A DEFECT OBSERVED PRIOR TO USE WITH A PATIENT. IT WAS NOTED THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). MEDTRONIC RECEIVED INFORMATION REGARDING THE AXIUM COIL HAVING A DEFECT OBSERVED WHICH LED TO THE DEVICE NOT BEING ABLE TO BE PASSED THROUGH THE CATHETER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14231925 ↗
• MalfunctionApr 5, 2022Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS STUCK IN THE DISTAL PORTION OF THE MICROCATHETER. THE DISTAL SEGMENT OF THE PUSHWIRE WAS DAMAGED, AND THE COIL DETACHED INSIDE THE MICROCATHETER. THE FULL SYSTEM WAS REMOVED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE BASILAR TIP. THE MAX DIAMETER WAS 4.8MM, AND THE NECK DIAMETER WAS 2.5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014892 ↗

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