Axium PrimeTM APB-4-6-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536031982), received between Oct 7, 2020 and Dec 7, 2022 — classified as 3 malfunctions.

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

• MalfunctionDec 7, 2022Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT REGARDING PHENOM CATHETER RESISTANCE AND AXIUM COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING INTRACRANIAL ANEURYSM TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT SIDE OF THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE ANEURYSM EMBOLIZATION SURGERY WAS PERFORMED AND THE SHAPEABLE MICROCATHETER PHENOM PLUS WAS SELECTED TO ESTABLISH THE PATHWAY. THE MICROCATHETER COULD NOT BE PUSHED OUT. IT WAS REPORTED THE CATHETER RESISTANCE OCCURRED IN THE DISTAL END. IT WAS ALSO REPORTED THE AXIUM COIL WAS SELECTED AND USED TO FORM A HOOP. THE SPRING COIL WAS STRETCHED. IT IS NOTED THAT COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL WAS REMOVED FROM THE PATIENT. THE COIL WAS STRETCH AND WAS IMMEDIATELY TAKEN OUT. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OBSERVED. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936168 ↗
• MalfunctionNov 7, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT. THERE WERE TWO MANUAL DETACHMENTS THAT WERE UNSUCCESSFUL AND IT WAS DETACHED WHEN IT WAS WITHDRAWN AS A WHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759883 ↗
• MalfunctionOct 7, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  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 PULLTHE 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 10640098 ↗

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