Axium Detachable Coil System QC-1.5-3-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037236), received between Jul 26, 2024 and May 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ECHELON 14 MICRO CATHETER AND BARE AXIUM HELICAL COIL, RESISTANCE WAS ENCOUNTERED AT THE CATHETER HUB, AND THE COIL COULD NOT BE ADVANCED INTO THE CATHETER. THE COIL BECAME STUCK AT THE CATHETER HUB AND WAS NOTED TO BE BENT. ADDITIONALLY, DAMAGE WAS OBSERVED AT THE PROXIMAL CATHETER, AND THE COIL ITSELF WAS ALSO REPORTED TO BE DAMAGED, THOUGH THE SPECIFIC LOCATION OF THE COIL DAMAGE WAS NOT IDENTIFIED. THE CATHETER AND COIL WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB, BUT THE IMPLANT COIL DID NOT PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE ARE 2 POTENTIAL CAUSES: ECHELON ERROR IS MAIN CAUSE (EX: THERE IS A QUITE LONG DISTANCE BETWEEN INTRODUCER SHEATH AND MICROCATHETER); THE TIP OF THE COIL IS CURVE (NOT STRAIGHT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963574 ↗
• MalfunctionJul 26, 2024Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL WAS AUTOMATICALLY STRETCHED AND THE COIL BODY WIRE DRAWN. LATER, AFTER IT WAS DETACHED, PART OF IT REMAINED IN THE PATIENT'S BODY, AND PART OF IT WAS REMOVED FROM THE BODY (PARTIAL REMOVAL) ALONG WITH THE PUSHER. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS BENT OR BROKEN (NOT ON PURPOSE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE MANUAL METHOD ONE TIME. NO INSTANT DETACHERS WERE USED. THE PHYSICIAN DID NOT  ROTATE THE DELIVERY PUSHER DURING PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 5.3MM AND A 4.7MM NECK DIAMETER. I

  Patient problems: Foreign Body In Patient

  MAUDE report 19839610 ↗

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