AxiumTM APB-4-6-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536008144), received between Jan 24, 2019 and Jun 17, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING COIL EMBOLIZATION OF A CEREBRAL ANEURYSM, WHEN THE PRODUCT WAS TAKEN OUT FROM THE OUTER BOX AND THE INNER BAG WAS OPENED, THE COIL WAS FOUND TO HAVE DETACHED FROM THE LOOP. CONSIDERING THE POSSIBILITY THAT THE TIP OF THE COIL HAD DETACHED, THE PHYSICIAN DETERMINED THAT THERE WAS A DEFECT AND DECIDED TO COLLECT IT. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22256900 ↗
• MalfunctionFeb 6, 2025Separation Failure; Migration; Separation Failure; Migration

  MEDTRONIC RECEIVED A REPORT THAT DURING COIL EMBOLIZATION OF ANEURYSM, AFTER THE COIL BODY WAS COMPLETELY FILLED, THE DETACHMENT WIRE WAS PULLED OUT TO DETACH THE COIL, AND THE PUSHER ROD WAS WITHDRAWN TO FIND THAT THE COIL BODY WAS PULLED OUT, AND IT WAS SUSPECTED THAT THE COIL WAS NOT SUCCESSFULLY DETACHED. AFTER REPEATED ADJUSTMENTS, THE COIL WAS FINALLY DETACHED, AND THE TAIL OF THE COIL BODY COULD ONLY REMAIN IN THE BLOOD VESSEL. LATER, A STENT WAS USED TO REMEDY THE SITUATION, PRESSING THE FREE COIL BODY AGAINST THE BLOOD VESSEL WALL. THERE WAS NON-DETACHMENT. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 3.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: Failure of Implant

  MAUDE report 21322187 ↗
• MalfunctionNov 7, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS BENT COMING OUT OF THE PACKAGING AT THE PROXIMAL END OF THE COIL. THE SECOND COIL WAS USED, HOWEVER, DID NOT DEPLOY. THE DEVICES WERE 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 AN ANEURYSM. ANCILLARY DEVICES INCLUDE A HEADWAY MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762458 ↗
• MalfunctionOct 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FIRST AXIUM COIL EXPERIENCED RESISTANCE DURING DELIVERY IN THE ECHELON MICROCATHETER. WHEN THE PHYSICIAN PULLED BACK ON THE COIL, THE COIL WAS DETACHED INSIDE THE CATHETER. IT WAS NOTED REPOSITIONING WAS PERFORMED 2-3 TIMES, NO DETACHMENT ATTEMPTS WERE MADE, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. SINCE THE COIL WAS INSIDE THE CATHETER, BOTH DEVICES WERE REMOVED TOGETHER. A SECOND COIL AXIUM COIL WAS THEN DELIVERED, BUT WHEN THE PHYSICIAN TRIED TO PULL THE COIL BACK OUT OF THE VESSEL, IT COMPLETELY DETACHED: PART IN THE A1 AND PART IN THE M1. THE COIL WAS FLUSHED IN THE M3 SEGMENT, AND A SOLITAIRE RETRIEVER WAS USED TO REMOVE THE COIL FROM THE PATIENT. IT WAS NOTED REPOSITIONING WITH THIS COIL WAS DONE 2-3 TIMES, ROTATION OF THE PUSHWIRE WAS DONE, AND A CONTINUOUS FLUSH WAS ALSO ADMINISTERED. REPLACEMENT DEVICES WERE USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL, AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10640101 ↗
• MalfunctionSep 3, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING THE EMBOLIZATION OF LEFT OPHTHALMIC ANEURYSM, AND A LEFT POSTERIOR COMMUNICATING ARTERY, THE A XIUM FAILED TO DETACH. THE INSTANT DETACHER AND MANUAL DETACHMENT WERE BOTH USED BUT BOTH METHODS FAILED. THE DEVICE WAS REMOVED AND REPLACED. THE NUMBER OF ATTEMPTS WAS NOT REPORTED BY THE USER. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8957153 ↗
• MalfunctionMar 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL PREMATURELY DETACHED. PRIOR TO THE EVENT, THE COIL WAS HANDLED AND WASHED ACCORDING THE TO THE INSTRUCTIONS FOR USE. THEN THE PUSHWIRE WAS ADVANCED INTO THE MICROCATHETER WHERE FRICTION WAS EXPERIENCED. AT THIS POINT, THE IMPLANT COIL WAS REMOVED FROM THE MICROCATHETER AND THE COIL WAS NOTICED TO BE DETACHED. ANOTHER COIL WAS USED TO COMPLETED THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE IMPLANT COIL AS DAMAGED; HOWEVER, THE MICROCATHETER WAS NOT DAMAGED. THE PUSHWIRE WAS NOT BENT OR BROKEN AND THERE WAS FRICTION DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION, ROTATE, OR ATTEMPT TO DETACH THE COIL. THERE WAS CONTINUOUS FLUSH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8424816 ↗
• InjuryJan 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE THIRD IMPLANT COIL PREMATURELY DETACHED AND FELL OUTSIDE THE ANEURYSM. IT WAS ATTEMPTED TO REMOVE THE COIL WITH A SNARE AS HE / SHE CONFIRMED THAT THERE WAS NO THROMBUS FORMATION 1 HOUR AFTER ADDITIONAL ADMINISTRATION OF CILOSTAZOL. THE PROCEDURE WAS COMPLETED. THE COIL WAS LEFT IN THE CEREBRAL BLOOD VESSEL. ONLY THE DELIVERY PUSHER WAS COLLECTED. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN ANEURYSM MEASURING 5 MM. THE PATIENT¿S VASCULATURE WAS MEDIUM IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8274059 ↗

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