Axium Prime Detachable Coil System APB-4-12-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536038554), received between Jan 13, 2023 and Sep 17, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT IT WAS A PARA OPHTHALMIC SEGMENT ANEURYSM. THE PHYSICIAN TOOK APB-4-12-HX-SS COIL AS THE THIRD COIL. WHEN THEY TOOK IT FROM THE HOOP, THEY FOUND THE COIL GOT DETACHED IN THE SLEEVE. SO THEY TOOK ANOTHER SAME SIZE COIL FROM ANOTHER MANUFACTURE AND COMPLETED THE CASE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. PREMATURE DETACHMENT HAPPENED WITHIN THE SLEEVE. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED PARA OPHTHALMIC SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075227 ↗
• MalfunctionJul 10, 2025Stretched; Stretched

  IT WAS REPORTED THAT DURING THE TREATMENT OF A RUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY USING THE AXIUM PRIME BARE HX 4MM X 12CM SUPER, A COIL STRETCH OCCURRED INSIDE THE MICROCATHETER. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 5MM AND A NECK DIAMETER OF 3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. THE COIL WAS RETRIEVED, AND ANOTHER COIL ( 4*15 SECOND COIL) WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NOT FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO ISSUE WITH THE CATHETER THAT WAS USED; THE CATHETER MODEL INFORMATION WAS NOT AVAILABLE. THE CAUSE WAS NOT DETERMINED, IT WAS ONLY INDICATED THAT THE COIL STRETCHED WITHIN THE CATHETER. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469308 ↗
• MalfunctionDec 2, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821137 ↗
• MalfunctionMay 31, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM PRIME COIL WAS STUCK IN THE CATHETER AND STRETCHED. WHEN THE COIL INSERTED TO MICROCATHETER THERE WERE RESISTANT. IT WAS THE 3RD COILS AFTER COSMOS 5X22 AND AXIUM 3D 4X12. THE DAMAGED COIL WAS PULLED OUT, AND REPLACED WITH AXIUM 4-10-3D-HX-SS. IT WAS STUCK IN THE PROXIMAL SECTION OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS OF USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED, AMORPHOUS ANEURYSM IN THE ACOM LOCATION. THE MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 5MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE PATIENT IS ALIVE WITH NO INJURY.  ANCILLARY DEVICES: CHAPERON 6F GUIDE CATHETER, HEADWAY 17 MICROCATHETER, AVIGO GUIDEWIRE, COIL MICROVENTION COSMOS 5X22 ADDITIONAL INFORMATION RECEIVED REPORTED NO PATIENT SYMPTOMS. THERE WAS RESISTANCE IN THE PROXIMAL END OF THE CATHETER. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029982 ↗
• MalfunctionJan 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED IN THE DISTAL PART OF THE MICROCATHETER DURING THE PROCEDURE. THE COIL WAS NOT REPOSITIONED, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PHYSICIAN HAD ROTATED THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED. THE PHYSICIAN CAREFULLY REMOVED THE ENTIRE SYSTEM, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE DISTAL ANTERIOR CEREBRAL ARTERY. THE MAX DI AMETER WAS 4.5MM, AND THE NECK DIAMETER WAS 2.00MM. THE PATIENT'S BLOOD FLOW WAS HIGH, AND THEIR VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A HEADWAY 17 MICROCATHETER AND AN AVIGO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159377 ↗

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