Axium Prime Detachable Coil System APB-5-20-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536038585), received between Mar 24, 2022 and Sep 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionSep 19, 2025Break; Separation Failure; Physical Resistance/Sticking; Break; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT HEALTHCARE PROVIDER (HCP) COULD NOT DETACH THE COIL. THE COIL PUSHER WIRE WAS BROKEN AND STUCK INSIDE THE DETACHER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WERE 5 ATTEMPTS MADE TO DETACH THE COIL USING THE INSTANT DETACHER. THERE WAS ONE ATTEMPT TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THE PUSH WIRE OF THE COIL WAS STUCK INSIDE THE DETACHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100656 ↗
• MalfunctionNov 21, 2022Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM (C6) WITH A MAX DIAMETER OF 5.5MM AND A 4.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THERE WAS ACCIDENTAL STRETCHING DURING STUFF OF THE SPRING COIL. COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. 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 AND DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. IT WAS UNKNOWN IF CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834176 ↗
• MalfunctionMar 24, 2022Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AN AXIUM PRIME COIL BECAME STRETCHED AND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS REPORTED THAT IN THE PROCESS OF PUSHING THE COIL, WHEN ADJUSTING THE POSITION OF THE COIL, THE COIL WAS STRETCHED AND BROKE/PREMATURELY DETACHED. A SOLITAIRE STENT WAS USED TO GRAB THE SPRING WIRE. THE COIL AND THE MICROCATHETER WERE REPLACED. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE HAD BEEN NO FRICTION/DIFFICULTY DURING DELIVERY. THE COIL HAD BEEN REPOSITIONED 3 TIMES. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. WHEN GRASPING FOR THE STRETCHED SPRING COIL, THE INTERNAL CAROTID ARTERY APPEARED DISSECTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY

  Patient problems: Vascular Dissection

  MAUDE report 13891652 ↗

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