Axium Detachable Coil System QC-2-3-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536037274), received between Aug 10, 2022 and Jan 31, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionJan 31, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN PASSING THE AXIUM COIL THROUGH THE ECHELON MICROCATHETER, A STRONG RESISTANCE FELT. AFTER THE ECHELON MICROCATHETER AND THE AXIUM WERE REPLACED, THE SAME ISSUE OCCURRED. A NEW MICROCATHETER WAS USED BUT STILL WAS NOT ABLE TO DELIVER THE 2 AXIUM COILS FROM BEFORE. THE AXIUM COILS AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE ECHELON WERE FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED POSTERIOR COMMUNICATING (PCOM) ARTERY LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 2.1MM AND A 1.5MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE MIDDLE SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614935 ↗
• MalfunctionNov 21, 2023Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION WAS REPORTED THAT THERE WAS JUST A BREAK, NOT PREMATURE DETACHMENT. THERE WERE NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) MADE. THERE WAS NO THERE ANY KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL DID NOT PREMATURELY DETACH IN THE CATHETER. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185938 ↗
• MalfunctionAug 10, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT 2 AXIUM COIL HAD RESISTANCE IN THE CATHETER AND DETACHED PREMATURELY. THE POSITION OF THE QC-2-3-HELIX DETACHABLE COIL WAS NOT IDEAL WHEN THE MICROCATHETER WAS PUSHED INTO THE ANEURYSM. WHEN READJUSTING, IT WAS FOUND THAT THE SPRING COIL COULD NOT BE PUSHED OUT. THE MICROCATHETER WAS PUSHED OUT FOR IN VITRO INSPECTION, FOUND THAT THE COIL HAD BEEN DETACHED ON ITS OWN IN ADVANCE. AFTER THE MICROCATHETER WAS IN PLACE AGAIN, SELECTED APB-2-3-HX-ES FOR FILLING. THE COIL WAS PUSHED INTO THE ANEURYSM. WHEN ADJUSTING THE FILLING, IT WAS FOUND THAT THE COIL COULD NOT BE PUSHED OUT AGAIN. BUT THE PUSH ROD COULD BE WITHDREW. WHEN WITHDRAWING, IT WAS FOUND THAT THE SPRING COIL HAD ALSO DETACHED IN ADVANCE. AFTER THE MICROCATHETER WAS IN PLACE AGAIN, CHOSE APB-1.5-3-HX-ES FOR EMBOLIZATION. THE SURGERY ENDED SUCCESSFULLY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE ANTERIOR  COMMUNICATING ARTERY ANEURYSM. THE MAX DIAMETER WAS 2.3MM AND THE NECK DIAMETER WAS 1.6MM. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202468 ↗

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