Axium Detachable Coil System QC-7-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536037878), received between Jul 20, 2022 and Mar 12, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Difficult or Delayed Positioning; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A BARE AXIUM 3D COIL (QC-8-30-3D) ENCOUNTERED RESISTANCE AND BECAME STUCK IN THE MIDDLE OF AN ECHELON 10 MICROCATHETER DURING DELIVERY, AND THE MIDDLE SEGMENT OF THE PUSHWIRE WAS FOUND TO BE KINKED. SINCE THE SAME MODEL COIL WAS UNAVAILABLE, THE COIL WAS REPLACED WITH A MEDTRONIC BARE AXIUM 3D COIL (QC-7-30-3D), HOWEVER, DELIVERY WAS STILL DIFFICULT, AND THE TIP OF THE COIL (PUSHWIRE DISTAL SEGMENT) WAS FOUND TO BE DAMAGED WHEN REMOVED. THE COIL WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, HEPATIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 8 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY AND CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE RESISTANCE AND THE PUSHWIRE KINK WAS NOT DETERMINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586774 ↗
• MalfunctionNov 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE CAUSE OF THE RESISTANCE DURING DELIVERY AND RETRACTION WAS UNCERTAIN, BUT IT WAS SPECULATED THAT THE GUIDEWIRE MIGHT HAVE KINKED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS A KINK TO THE COIL OBSERVED AFTER REMOVAL. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512759 ↗
• MalfunctionJan 6, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE CATHETER WAS POSITIONED 2-3 CM FROM THE HEAT SOURCE DURING SHAPING. THE CATHETER WAS SHAPED WITH THE HEAT SOURCE FOE 5 SECONDS. THERE WERE 0 ATTEMPTS MADE TO DETACH THE COIL USING THE INSTANT DETACHER. THERE WERE 2 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078591 ↗
• MalfunctionJun 14, 2024Stretched; Migration; Stretched; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED SINCE THE COIL WAS INSIDE THE BODY, IT WAS IMPOSSIBLE TO JUDGE THE DETACHMENT ISSUE. THE PATIENT WAS ADMINISTERED CONVENTIONAL PREOPERATIVE ANTIPLATELET THERAPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19538931 ↗
• MalfunctionMar 12, 2024Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL HAD ALREADY DETACHED. AFTER TEARING OPEN THE PACKAGE, THE COIL COULD NOT BE PUSHED INTO THE MICROCATHETER FOR EMBOLIZATION. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED RIGHT INTERNAL CAROTID M3 SEGMENT ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 8.2 MM, NECK DIAMETER 3.7 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL AND BLOOD FLOW WAS NORMAL. AFTER PUSHING THE MICROCATHETER IN PLACE, THE DETACHABLE SPRING COIL WAS FIRSTLY SELECTED FOR FORMING HOOP. AFTER TEARING OPEN THE PACKAGE, IT WAS FOUND THAT THE SPRING COIL HAD ALREADY DETACHED AND COULD NOT BE PUSHED INTO THE MICROCATHETER FOR EMBOLIZATION. THE DEVICE WAS REPLACED AND THE SUBSEQUENT SURGERY WENT SMOOTHLY. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887585 ↗
• MalfunctionMar 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT PREMATURE DETACHMENT WAS OBSERVED INTRA-OP. TO CLARIFY THE "COIL WAS OFF WIRE," PREMATURE DETACHMENT OCCURRED WHEN DETACHING. THERE WAS ONE DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) MADE USING THE MANUAL METHOD. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS IMPLANTED. THE CATHETER MODEL AND LOT NUMBER ARE UNKNOWN. THERE WERE FIVE COILS IMPLANTED BEFORE AND AFTER THIS MALFUNCTIONED COIL. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION BUT THE COIL WAS PUSHED INTO THE ANEURYSM WITH A STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512372 ↗
• MalfunctionNov 17, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO DAMAGE TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819299 ↗
• MalfunctionJul 20, 2022Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN ECHELON-10 MICROCATHETER WAS IN PLACE AND A QC-8-30-3D WAS CHOSEN FOR THE FIRST HOOP. AFTER BEING PUSHED OUT IN VITRO, IT WAS FOUND THAT IT COULD NOT BE FORMED A HOOP, AND THEN QC-7-30-3D WAS REPLACED TO FORM A HOOP, AND IT WAS AUTOMATICALLY DETACHED IN THE MICROCATHETER, SO IT WAS COMPLETELY WITHDRAWN. THEY RE-USED THE MICROCATHETER ECHELON-10 ((B)(4)) IN PLACE, SELECTED QC-8-20-3D FOR FORMING A HOOP, AND FILLED IN APB-6-20-3D-SS, APB-3-8--3D-ES, TWO APB-2-4-3D-ES, APB-1.5-4-HX-ES, THE CATHETER TIP WAS WITHDRAWN FROM THE NECK OF THE TUMOR, AND THERE WAS NO MORE FILLING. AFTER ANGIOGRAPHY, THE TUMOR DID NOT DEVELOP, AND THE OPERATION WAS FINISHED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY SEGMENT WITH A MAX DIAMETER OF 8MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070409 ↗

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