AxiumTM APB-5-15-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536008229), received between Jan 24, 2019 and Aug 8, 2025 — classified as 1 death, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL WAS "SNAKING" INSIDE THE SHEATH WHICH WAS CONSIDERED TO BE THE CAUSE OF THE RESISTANCE. IT WAS NOTED THAT THE INTRODUCER SHEATH WAS HELP VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED PER THE IFU. MDR CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755208 ↗
• MalfunctionApr 2, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL STRETCHED UPON DEPLOYMENT AND DETACHED WHILE HALF OF IT WAS STILL IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED ANEURYSM LOCATED IN THE BASILAR TIP. IT WAS REPORTED THAT THE COIL STRETCHED UPON DEPLOYMENT. THE DOCTOR STARTED TO WITHDRAW THE MICROCATHETER AND NOTICED THE COIL HAD S TRETCHED. IT DETACHED HALF IN THE ANEURYSM AND HALF IN THE MICROCATHETER. ONCE IT WAS DETACHED WITHIN THE CATHETER, THE DOCTOR HAD TO PUSH IT OUT AND SEVERAL LOOPS FELL OUT OF THE ANEURYSM INTO THE PCA. THE DOCTOR HAD TO PUT A SECOND STENT WITHIN THE PCA TO TRAP THE COILS BETWEEN THE INITIAL STENT AND THE BAIL OUT STENT. THERE HAD BEEN NO FRICTION/DIFFICULTY DURING TESTING OR DELIVERY, AND A CONTINUOUS FLUSH HAD BEEN USED. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606763 ↗
• DeathApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER COILING. THE PATIENT PRESENTED WITH HEMORRHAGE. THE PATIENT HAD A RUPTURED, SACCULAR ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT COILING IN ORDER TO IMPROVE THE SITUATION. THE PATIENT UNDERWENT IMPLANTATION OF 13 COILS INCLUDING 9 MEDTRONIC COILS. THE PATIENT REPORTEDLY PASSED AWAY POST-PROCEDURE DUE TO THE MASSIVE HEMORRHAGE.

  Patient problems: Death

  MAUDE report 8483789 ↗
• MalfunctionJan 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL WAS FOUND TO BE RELEASED FROM INSIDE THE PROTECTIVE SHEATH. IT WAS NOT IMPLANTED IN THE PATIENT AND WILL BE RETURNED FOR EVALUATION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 4 MM X 2 MM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE PATIENT¿S VASCULATURE WAS MINIMAL IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. THE REPORTED DEVICE AND ANCILLARY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE PUSHWIRE WAS NOT BENT OR BROKEN AND THERE WAS NO FRICTION DURING DELIVERY. THE COIL WAS REPOSITIONED AND THE PUSHWIRE WAS NOT ROTATED DURING DELIVERY. A CONTINUOUS FLUSH WAS MAINTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273271 ↗

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