AxiumTM APB-4-12-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536008137), received between Jul 9, 2018 and Apr 8, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A KINK WAS OBSERVED IN THE PROXIMAL REGION OF THE AXIUM PRIME BARE PUSHWIRE. IN REGARDS TO WHEN THE KINK WAS OBSERVED, IT WAS REPORTED THAT IT WAS ALREADY "BROKEN" WHEN IT WAS OPENED FROM THE PACKAGE. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. THE PRODUCT WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR VA PAO (VERTEBRAL ARTERY PARENT ARTERY OCCLUSION). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS FLUSHING WAS PERFORMED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817875 ↗
• MalfunctionMar 18, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING ANOTHER INSTANT DETACHER. THE PH YSICIAN ATTEMPTED TO DETACH THE COIL MANUALLY VIA THE HYPOTUBE. THE "DETACHER ERROR" STATED MEANS THEY WERE UNABLE TO DETACH THE COIL. THE "POOR DISLODGEMENT" MEANS DETACHMENT FAILURE. THE COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631148 ↗
• MalfunctionJan 31, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THE CAUSE OF THE NON-DETACHMENT WAS NOT IDENTIFIED. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPO TUBE. THERE WAS NO ISSUE REPORTED WITH THE INSTANT DETACHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618931 ↗
• MalfunctionNov 27, 2023Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT IN THE MIDDLE OF THE ECHELON, THE PHYSICIAN STARTED GETTING RESISTANCE WHILE ADVANCING THE AXIUM COIL PUSHER WIRE. NO FORWARD MOVEMENT OF THE AXIUM PUSHER WIRE. WHILE RETRIEVING THE AXIUM COIL BACK, IT GOT DAMAGED. ANOTHER COIL WAS REPLACED AND IMPLANTED. THE ECHELON WAS NOT DAMAGED BUT THE AXIUM COIL WAS DAMAGED ON RETRIEVAL. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.9MM AND A 3.2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.   ANCILLARY DEVICES INCLUDE A NEURONMAX SHEATH, NAVIEN 6F GUIDE CATHETER, AVIGO GUIDEWIRE, AND A HYPERFORM. 2023-09-16 EMAIL (FOR, REP, HCP): ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE MIDDLE SECTION OF THE CATHETER. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. COIL DAMAGE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211338 ↗
• MalfunctionNov 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS IMPLANTED IN THE BODY. THE STENT DEPLOYED WAS TO SECURE THE COIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 15743861 ↗
• MalfunctionJun 1, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE FIRST LOOP OF THE COIL COULD NOT ENTER THE CATHETER. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14568622 ↗
• MalfunctionDec 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION RECEIVED REPORTING THAT AN AXIUM COIL DETACHED PREMATURELY. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT. NO OTHER INFORMATION WAS KNOWN AND THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011172 ↗
• MalfunctionNov 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING A COIL EMBOLIZATION PROCEDURE, AN AXIUM COIL DETACHED PREMATURELY. IT WAS NOTED THE EVENT WAS ASSOCIATED WITH A PATIENT BUT ALSO THAT THE COIL WAS "UNCHARGED WITHOUT A PATIENT LOAD." NO OTHER INFORMATION WAS KNOWN OR AVAILABLE. IT WAS UNKNOWN IF THERE WAS ANY IMPACT TO THE PATIENT. IT WAS UNKNOWN IF THE COIL WAS IMPLANTED OR REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 12887375 ↗
• MalfunctionJul 9, 2018Loss of or Failure to Bond; Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING PROCEDURE THE AXIUM COIL WOULD NOT DETACH WITH AN INSTANT DETACHER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR CEREBRAL ARTERIOVENOUS FISTULA/EMBOLIZATION. THE TORTUOSITY WAS MEDIUM LEVEL AND SMALL IN VESSEL DIAMETER. IT WAS NOTED THAT IN ORDER TO PREVENT THE MICROCATHETER MOVING FROM THE TARGET LOCATION THE HEALTHCARE PROFESSIONAL (HCP) REMOVED THE AXIUM WITHOUT ATTEMPTING MANUAL DETACHMENT. AS A RESULT A NEW AXIUM WAS OPENED WITH THE COIL ABLE TO BE DETACHED FROM THE SAME INSTANT DETACHER SUCCESSFULLY. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7670616 ↗

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