AxiumTM APB-5-8-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536008243), received between Dec 13, 2018 and Sep 8, 2022 — classified as 1 death, 4 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 16, 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.

• MalfunctionSep 8, 2022Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO KINK/DAMAGE¿OBSERVED¿ON THEPUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380927 ↗
• MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT WHEN INSERTING THE COIL INTO THE ANEURYSM, WHEN ABOUT 3 CM WAS REMAINING, THE DELIVERY PUSHWIRE OF THE COIL PULLED, AND IT WAS CONFIRMED THE COIL DID NOT MOVE WITH IT: THE COIL DETACHED EARLY. AS TROUBLESHOOTING, THE PUSHWIRE WAS USED TO PUSH THE COIL AND IMPLANT THE COIL INTO THE ANEURYSM AT THE EXPECTED POSITION. IT WAS NOTED THERE WAS NO DAMAGE TO THE PUSHWIRE, NO REPOSITIONING OF THE COIL WAS PERFORMED, NO ROTATION OF THE PUSHWIRE WAS PERFORMED, AND NO DETACHMENT ATTEMPTS WERE MADE. IT WAS UNKNOWN IF THERE WAS ANY RESISTANCE DURING DELIVERY, AND UNKNOWN IF A CONTINUOUS FLUSH HAD BEEN USED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND 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 ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 5 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. ANCILLARY DEVICES INCLUDE A PHENOM 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244073 ↗
• MalfunctionAug 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT COILS DETACHED PREMATURELY DURING TREATMENT FOR AN ANEURYSM. NO PATIENT INJURY WAS REPORTED. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. VESSEL TORTUOSITY WAS REPORTEDLY SEVERE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8886267 ↗
• DeathJul 30, 2019Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED ADDITIONAL EVENT INFORMATION: MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER AXIUM PRIME PLACEMENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION OF A BIFURCATING ANEURYSM IN THE LEFT MIDDLE CEREBRAL ARTERY. THE ANEURYSM WAS DESCRIBED AS SMALL WITH A 5MM DOME. THE ANATOMY WAS REPORTED TO HAVE BEEN SEVERE IN TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. AT BASELINE, THE PATIENT HAD WFNS OF 1. IT WAS REPORTED THAT DURING THE PROCEDURE, THE AXIUM WAS ADVANCED THROUGH THE CATHETER (MODEL/LOT UNKNOWN) WITH RESISTANCE. THE COIL WAS REPOSITIONED THREE TIMES AND REPORTEDLY BECAME STRETCHED. THE COIL BECAME DETACHED AND WAS IMPLANTED IN AN UNINTENDED LOCATION ("INCORRECT POSTING"). THERE WERE REPORTEDLY NO DETACHMENT ATTEMPTS MADE. MEDICAL / SURGICAL INTERVENTION WAS REQUIRED, AND THE HOSPITALIZATION WAS EXTENDED. THE PATIENT REPORTEDLY PASSED AWAY DUE TO "INCORRECT POSTING AFTER EV3 DETACHMENT USE."

  Patient problems: Death; Foreign Body In Patient

  MAUDE report 8841528 ↗
• MalfunctionDec 13, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 AXIUM PRIME COILS AND 1 CONCERTO COIL FAILED TO DETACH. IT WAS REPORTED THAT UPON DELIVERY OF THE COIL, DETACHMENT WAS ATTEMPTED USING THE INSTANT DETACHER (ID), BUT THE COIL DID NOT DETACH. THEN DETACHMENT WAS ATTEMPTED WITH THE HYPOTUBE BREAK METHOD, BUT THE COIL DID NOT DETACH. 2 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND ONE ATTEMPT WAS MADE VIA THE SECOND DETACHMENT METHOD. THE PUSHWIRE WAS SEATED DEEP INTO THE ID WHEN THE DETACHMENT ATTEMPTS WERE MADE. THE DEVICES WERE RETRIEVED AND REMOVED FROM THE ANATOMY. THE COILS WERE REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED, AND COILS WERE HYDRATED PER THE IFU. CONTINUOUS FLUSH WAS NOT USED DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED. THE ID AND THE COILS WILL BE RETURNED FOR ANALYSIS. NO ISSUES WERE REPORTED WITH THE ID. THE ANATOMY WAS MODERATE IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161069 ↗

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