Axium Detachable Coil System QC-4-12-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536037403), received between May 19, 2022 and Dec 16, 2025 — classified as 1 injury, 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 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.

• InjuryDec 16, 2025Break; Therapy Delivered to Incorrect Body Area; Stretched; Separation Failure; Detachment of Device or Device Component; Break; Therapy Delivered to Incorrect Body Area; Stretched; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS COIL BREAK/SEPARATION AS WELL AS PREMATURE DETACHMENT. THE COIL PREMATURELY DETACHED FROM NON-DETACHMENT. THERE WERE NO ISSUES WITH THE ECHELON. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. IT WAS NOTED THERE WERE NO ISSUES WITH THE INSTANT DETACHER.

  Patient problems: Foreign Body In Patient

  MAUDE report 23824538 ↗
• MalfunctionNov 5, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS AN OCCLUSION OF BLOOD VESSELS MEASURING ABOUT 3 MM. THE PATIENT IS RECOVERING NORMALLY AND DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO COIL PREMATURE DETACHMENT OR DAMAGE. AN ABNORMALITY WAS FELT DURING THE PROCESS OF DELIVERING THE COIL INTO THE MICROCATHETER THROUGH THE INTRODUCER SHEATH, AND IT WAS SUBSEQUENTLY DISCOVERED THAT THE COIL HAD BEEN PREMATURELY DETACHED. THE DAMAGE OR FRACTURE WAS NOT IN ADDITION TO THE DETACHMENT. ALL DEVICES AND ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CAUSES OF THE PREMATURE DETACHMENT AND COIL DAMAGE WERE NOT DETERMINED, AND NO ISSUES WERE IDENTIFIED THAT RESULTED IN THE OBSERVED DAMAGE. NO DETACHMENT ATTEMPTS WERE MADE USING AN INSTANT DETACHER OR MANUAL METHOD. IT WAS UNKNOWN IF ANY KINK OR DAMAGE OBSERVED ON THE PUSHWIRE SINCE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479348 ↗
• MalfunctionJan 18, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE, THE AXIUM SPRING COIL HYDRATION DELIVERY MICROCATHETER WAS FOUND TO BE UNABLE TO BE DEPLOYED AFTER IT WAS IN PLACE. THE COIL WAS WITHDRAWN. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS CLARIFIED THAT THE COIL DID NOT EXPERIENCE ANY RESISTANCE IN THE MICROCATHETER, AND THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL. THE CATHETER USED WAS A MEDTRONIC PRODUCT, BUT THE MODEL/LOT # WERE NOT RECORDED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY IN THE C4 SEGMENT 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 NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536371 ↗
• MalfunctionDec 8, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE RESISTANCE WAS LOCATED IN THE PROXIMAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS A MEDTRONIC PRODUCT BUT THE LOT AND MODEL NUMBER ARE UNKNOWN. THERE WERE NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18296763 ↗
• MalfunctionMay 19, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD RESISTANCE IN THE CATHETER AND PREMATURELY DETACHED. IN THE PROCESS OF PUSHING THE COIL, THE SURGEON FOUND THAT IT HAD ABNORMAL RESISTANCE. AFTER WITHDRAWING AND CHECKING THE SPRING COIL, AND FOUND THAT IT WAS AUTOMATICALLY DETACHED. AT THE SAME TIME, THERE WAS NO VIOLENT OPERATION BY THE SURGEON. IT WAS NOT IMPLANTED IN THE BODY, AND IT WAS RETURNED WHEN THE RESISTANCE WAS ABNORMAL AT THE Y VALVE. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO OTHER FRICTION OR DIFFICULTY DURING DELIVERY/ THE PHYSICIAN DID NOT REPOSITION THE COIL OR ATTEMPT TO DETACH THE COIL. THEY DID NOT ATTEMPT TO ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE OPHTHALMIC ARTERY. THE MAX DIAMETER WAS 5.67MM AND THE NECK DIAMETER WAS 3.32MM. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437776 ↗

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