Axium Prime Detachable Coil System APB-6-20-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536038301), received between Jan 19, 2022 and Aug 25, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891782 ↗
• MalfunctionJan 8, 2025Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL BECAME STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR VERTEBRAL ANEURYSM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE FOURTH 4TH COIL THE DOCTOR TRIED TO INSERT WAS NOT PROPER, SO THEY WANTED TO REPOSITION. THEY RETRIEVED THE COIL TO INSERT AGAIN, BUT THAT COIL DIDN'T GO BACK WHILE THEY PULLED THE PUSHWIRE. AT THAT TIME THE DOCTOR THOUGHT THE COIL HAD AUTO DETACHED, SO THEY DECIDE TO PULL IT OUT OF THE PATIENT. FINALLY THE COIL WAS ABLE TO GO OUT FROM THE PATIENT, AT WHICH TIME IT WAS SEEN TO BE STRETCHED VERY LONG. THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE COIL HAD BEEN REPOSITIONED 1-2 TIMES. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A NON-MEDTRONIC GUIDE CATHETER AND MICROCATHETER. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE DOCTOR WAS CONCERNED HOW MUCH THE POWER LIMIT TO PUSH OR PULL COIL TO AVOID THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108259 ↗
• MalfunctionMar 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY. A PRE-DETACH OCCURED BEFORE THE COIL WAS DETACHED. THE PROCEDURE WAS COMPLETED BY PUSHING IN THE WIRE. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 3MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: SOFIA 6F GUIDE CATHETER, HEADWAY 17 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007730 ↗
• MalfunctionMar 16, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL HAD COIL RESISTANCE/STUCK IN CATHETER AND THE DELIVERY WIRE WAS PREMATURELY DETACHED FROM THE COIL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE MIDDLE CEREBRAL ARTERY BIFURCATION WITH A MAX DIAMETER OF 5.32 MM AND A 4.26 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT LEFT MIDDLE ARTERY BIFURCATION ANEURYSM, LOBULATED, MODERATELY CURVED CAVERNOUS SINUS SEGMENT (TYPE III). CHOSE PRIME SS 6X20 3D FOR THE FIRST COIL. WHEN THE PROXIMAL END OF THE COIL WAS PUSHED TO THE ANTERIOR CURVATURE OF THE CAVERNOUS SINUS, THE RESISTANCE WAS RELATIVELY LARGE. UNDER THE RAY, IN A WAVY SHAPE. THE DELIVERY GUIDE WIRE WAS WITHDRAWN AND FOUND TO BE DETACHED. WITHDREW ECHELON, USED SOLITAIRE4-20 TO REMOVE THE COIL FROM THE BODY. AFTER REPLACED THE MICROCATHETER AND THE COIL, THE FILLING WAS SMOOTH, AND THE PATIENT HAD NO SPECIAL PROBLEMS AFTER THE SURGERY. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE DISTAL SECTION OF THE CATHETER. IT IS UNKNOWN IF THERE WAS CATHETER DAMAGE. THERE WAS DAMAGE OBSERVED TO THE COIL. THE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552327 ↗
• MalfunctionFeb 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE DISTAL PORTION OF THE CATHETER. THE INDUCER SHEATH CAME OUT SMOOTHLY. AFTER REMOVAL THE COIL/PUSHWIRE WAS A LITTLE KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359209 ↗
• MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE SURGERY, AFTER THE MICROCATHETER WAS IN PLACE, THE COIL FILLING WAS PERFORMED. THE FIRST COIL APB-6-20-3D-SS WAS CHOSEN TO BE USED. DURING THE DELIVERY OF THE SPRING COIL, THE SPRING COIL WAS DETACHED IN ADVANCE WHEN IT WAS NOT IN THE IDEAL STATE. LATER, THE MICRO-GUIDE WIRE WAS USED FOR AUXILIARY ADJUSTMENT, AND THE SURGERY WAS CONTINUED. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PUSHWIRE WILL BE RETURNED FOR EVALUATION. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COULD. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT SIDE CAVERNOUS SINUS ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725270 ↗
• MalfunctionSep 9, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN PUSHING THE SPRING COIL, THE RESISTANCE WAS VERY LARGE. THE SPRING COIL PUSH ROD WAS WITHDRAWN. ONLY THE PUSH ROD COULD BE WITHDRAWN AS THE COIL WAS STUCK IN THE MICROCATHETER. THE RESISTANCE WAS AT THE MIDDLE AND DISTAL END OF THE CATHETER. IT WAS UNKNOWN IF THE CATHETER WAS DAMAGED, HOWEVER, THE COIL WAS DAMAGED. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED POSTERIOR CEREBRAL ANEURYSM WITH A MAX DIAMETER OF 9MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE OCCURRED WITH THE COIL IN THE ECHELON CATHETER LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396455 ↗
• MalfunctionJan 19, 2022Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PREMATURELY DETACHED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 7MM NECK DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13295482 ↗

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