Axium Detachable Coil System QC-2-6-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536037298), received between Jun 9, 2023 and Jan 14, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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.

• MalfunctionJan 14, 2026Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE COIL RESISTANCE/STUCK IN CATHETER WAS NOT DETERMINED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068398 ↗
• MalfunctionNov 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE PUSHED INTO THE CATHETER, AND EXPERIENCED RESISTANCE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN ECHELON MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560177 ↗
• MalfunctionMar 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) CLINOID SEGMENT, THE BARE AXIUM HELIX COIL WAS USED. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 4 MM AND A NECK DIAMETER OF 3.8 MM. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THERE WAS NO COIL ALIGNMENT MARK ON THE COIL PUSH ROD, MAKING IT IMPOSSIBLE TO DETERMINE WHETHER THE COIL COULD BE DETACHED. AS A RESULT, THE COIL WAS WITHDRAWN. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE REPORTED AS NORMAL. THE PRODUCT WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682706 ↗
• MalfunctionJan 2, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE TREATMENT OF A RUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY, A COIL-RELATED ISSUE OCCURRED WITH THE AXIUM HELIX COIL AND AXIUM 3D COIL, WHERE THE COIL BECAME STUCK IN THE SHEATH THREE TIMES. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 5 MILLIMETERS AND A NECK DIAMETER OF 2 MILLIMETERS, WITH MODERATE VESSEL TORTUOSITY AND NORMAL BLOOD FLOW. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE ISSUE INVOLVED COIL RESISTANCE AND THE COIL BEING STUCK IN THE SHEATH. THE RESOLUTION OR OUTCOME OF THE EVENT WAS NOT SPECIFIED. 2024-12-09 E1 (FOR, DIS, HCP): ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL ACCIDENTALLY BROKE DURING THE PROCEDURE, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063995 ↗
• MalfunctionJun 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT TO CLARIFY THE COILS REMAIN IN THE PATIENT. IT IS UNKNOWN IF THERE ARE FUTURE MEDICINAL/SURGICAL INTERVENTION PLANNED TO REMOVE THE COILS. THE ANATOMICAL LOCATION OF THE COILS IS THE INTERNAL CAROTID ARTERY. THERE ARE NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT, ANGIO, ETC.) AVAILABLE. FOR AXIUM COIL (LOT # 225113020) THE RESISTANCE LOCATION IS UNKNOWN. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE ECHELON CATHETER LOT NUMBER WAS B476715.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097733 ↗

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