Axium Detachable Coil System QC-1.5-2-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00847536037229), received between Jul 13, 2022 and Oct 15, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT NO ISSUES WERE ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302971 ↗
• MalfunctionMay 8, 2025Migration; Migration

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A PIPELINE EMBOLIZATION DEVICE FOR A RIGHT C5 SEGMENT INTRACRANIAL ANEURYSM, SEVERAL PROCEDURAL ISSUES OCCURRED. THE ANEURYSM HAD AN AMORPHOUS MORPHOLOGY WITH A MAXIMUM DIAMETER OF 2.1 MM AND A NECK DIAMETER OF 2*1.6 MM. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7 MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. DURING THE PROCEDURE, INCREASED TENSION WAS NOTED IN THE SHAPABLE MICROCATHETER AFTER THE STENT DELIVERY, AND THE STENT COULD NOT BE PUSHED FORWARD DESPITE MULTIPLE ATTEMPTS. THEY WITHDREW THE STENT BACK TO THE SHEATH AND REMOVED THE MICROCATHETER TO CHECK AND FOUND THERE WAS THE ISSUE WITH THE CONTACT PORT PUSH. THE STENT WAS DEPLOYED IN VITRO IN A GOOD SHAPE, AND THE SHAPABLE MICROCATHETER WAS REPLACED TO DELIVER THE STENT, BUT AFTER HALF OF THE STENT WAS DELIVERED, IT COULD NOT BE PUSHED FORWARD. REPEATED ATTEMPTS FAILED TO PUSH IT FORWARD. CATHETER RESISTANCE WAS ENCOUNTERED IN THE MIDDLE SECTION, AND THE PUSH WIRE BROKE DURING THE OPERATOR'S PROCESS OF WITHDRAWING THE STENT IN THE MICROCATHETER. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE IFU. ON (B)(6) 2025 E1 (FOR, REP, HCP): ADDITION

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21989386 ↗
• MalfunctionMay 8, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT "THE HOSPITAL CANCELLED ACCORDING TO PROCEDURE" MEANT THAT THE USE OF THE COIL WAS STOPPED. THE PROCEDURE COMPLETED BY NEW ECHELON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986614 ↗
• MalfunctionMay 8, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE HOSPITAL CANCELLED ACCORDING TO PROCEDURE. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 4.5 MM AND A 1.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE RESISTANCE/DAMAGE WAS PREDICTED THAT DUE TO THE SMALL COIL BEING TOO SOFT GOING THROUGH THE HUB SECTION IT WAS FOLDED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986566 ↗
• MalfunctionMay 8, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY USING A BARE AXIUM HELIX COIL, THE COIL COULD NOT BE PUSHED INTO THE ECHELON CATHETER, AND THE COIL HEAD WAS DEFORMED. THE COIL EXPERIENCED RESISTANCE AND BECAME STUCK IN THE CATHETER, SPECIFICALLY AT THE CATHETER HUB AND DISTAL SEGMENT. THE COIL WAS DAMAGED AT THE PUSHWIRE DISTAL SEGMENT. THERE WAS NO DAMAGE TO THE CATHETER. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE COIL WAS REPLACED BY ANOTHER MEDTRONIC PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE ANEURYSM MAX DIAMETER WAS 3.2MM, AND THE NECK DIAMETER WAS 1.5MM. ADDITIONAL INFORMATION RECEIVED REPORTED 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 21986045 ↗
• MalfunctionMar 24, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE USE OF A BARE AXIUM HELIX COIL, THERE WERE ISSUES WITH COIL RESISTANCE AND THE COIL BECOMING STUCK IN THE CATHETER, SPECIFICALLY AT THE CATHETER HUB. THE COIL WAS ALSO REPORTED TO BE DAMAGED. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE COIL COULD NOT BE PUSHED INTO THE CATHETER. THE CUSTOMER WAS NOTIFIED THAT THE PRODUCT SHOULD BE RETURNED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684421 ↗
• MalfunctionDec 27, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE IN THE CATHETER AND WAS FOUND DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE C4 SEGMENT WITH A MAX DIAMETER OF 2 MM AND A 2.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE PATIENT HAS HAD A PAST MEDICAL HISTORY OF HYPERTENSION FOR SEVERAL YEARS. IT WAS REPORTED THAT THE AXIUM COIL COULD NOT BE PUSHED IN THE MICROCATHETER AND WAS THEN WITHDRAWN FROM THE BODY. THE COIL WAS FOUND TO BE DAMAGED. A NEW COIL WAS REPLACED AND THE OPERATION WAS CONTINUED. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE COIL DAMAGE AND RESISTANCE WAS NOT DETERMINED. CATHETER RESISTANCE OCCURRED IN THE PROXIMAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER USED WAS AN ECHELON. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028161 ↗
• MalfunctionNov 7, 2024Break; Break

  THERE WAS NO REPORTED ISSUE WITH THE DEVICE HOWEVER, ANALYSIS FOUND A NON-CONFORMANCE. MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE ECHELON 14 AND ECHELON 10 MICROCATHETERS. THE COIL WAS STUCK IN THE PROXIMAL PART OF THE MICROCATHETER. THE COIL HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634246 ↗
• InjuryAug 12, 2024Break; Unintended Movement; Break; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT DURING DEPLOYMENT OF THE LAST AXIUM COIL IN ANEURYSM, COIL ACCIDENTALLY BROKE AND A PART OF COIL IS OUTSIDE ANEURYSM (IN CARRYING VESSEL). THE DOCTOR USED A SNARE TO TAKE THAT PART OF COIL OUTSIDE BUT CAN NOT DO IT. LUCKILY, THAT PART OF THE COIL IS CLOSE TO WALL OF VESSEL. THEY HAD TO USE ANTIPLATELET AND CLOSELY FOLLOW UP, THE DEVICE REMAINED IN THE PATIENT. A PART OF COIL IS GOING OUT OF ANEURYSM AND PATIENT IS USING ANTIPLATELET. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN HAD REPOSITIONED THE COIL "SEVERAL TIMES." THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL.   ANCILLARY DEVICES INCLUDED AN ECHELON MICROCATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 19961046 ↗
• MalfunctionAug 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO COILS ENCOUNTERED RESISTANCE IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED C7 ANEURYSM WITH A MAX DIAMETER OF 4.3MM AND A 2.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT DURING THE ANEURYSM SURGERY, THE COILS COULD NOT ENTER THE MICROCATHETER. THE DEVICES WERE REPLACED, AND THE SURGERY WENT SMOOTHLY. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949987 ↗
• MalfunctionMar 14, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2024 DURING THE ANEURYSM EMBOLIZATION OPERATION, THE SURGEON FIRST INSERTED THE ECHELON MI CROCATHETER INTO THE DISEASED TUMOR. HOWEVER, THE MICROCATHETER HAD INSUFFICIENT SUPPORT AND WAS DIFFICULT TO PLACE, AND THEN NAVIEN WAS SELECTED FOR MICROCATHETER RELEASE. DURING THE RELEASE PROCESS, THE RESISTANCE OF THE SUPPORT CATHETER SUDDENLY INCREASED. THE SURGEON ROTATED THE ANGLE AND TRIED SEVERAL TIMES. THE RESISTANCE OF THE SUPPORT CATHETER WAS STILL HIGH. THE SUPPORT CATHETER WAS THEN TAKEN OUT, FLUSHED AND INSPECTED. IT WAS FOUND THAT THE CATHETER BODY WAS KINKED IN THE MIDDLE. THEN THE SUPPORT CATHETER WAS ABANDONED TO ASSIST IN POSITIONING IT, AND THE MICROCATHETER WAS FINALLY IN POSITION SUCCESSFULLY AFTER MULTIPLE ADJUSTMENT ATTEMPTS. AFTER THE MICROCATHETER WAS IN PLACE, THE EARLY PACKING COILS WERE RELEASED SMOOTHLY, AND THERE WAS NO ABNORMALITY. WHEN THE COIL WAS SELECTED FOR RELEASE, THE COIL RELEASE ROD (PUSHER) BROKE. THE SURGEON TRIED TO BRIDGE THE RELEASE ROD AND FAILED TO RELEASE AGAIN, AND FINALLY RETRIEVED THE SPRING COIL AND EXITED THE BODY. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907356 ↗
• MalfunctionOct 9, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHER WIRE. IT WAS NOTED THAT 1 COIL HAD BEEN SUC CESSFULLY DELIVERED PRIOR TO THE FAULTY COIL AND 2-3 MORE COILS WERE DELIVERED AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901839 ↗
• MalfunctionAug 21, 2023Break; Detachment of Device or Device Component; Packaging Problem; Break; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE AXIUM COIL WAS TAKEN OUT OF THE PACKAGE FOR INSPECTION, THE AXIUM COIL WAS DETACHED ALREADY, AND THE SURGEON RETURNED IT FOR IDENTIFICATION. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A ECHELON MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592462 ↗
• MalfunctionFeb 20, 2023Stretched; Packaging Problem; Stretched; Packaging Problem

  MEDTRONIC RECEIVED A REPORT REGARDING AN AXIUM COIL FOUND TO BE STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER OPENING THE SPRING COIL PACKAGE, IT WAS FOUND THAT THE COIL BODY WAS STRETCHED. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. IT WAS UNKNOWN IF THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405065 ↗
• MalfunctionJul 18, 2022Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STUCK IN THE DISTAL PART OF THE MICROCATHETER AND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3.0MM, AND THE NECK DIAMETER WAS 2.3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT IN THE PROCESS OF CONTINUOUSLY FILLING, THE COIL WAS ADJUSTED AND IT WAS FOUND TO HAVE DETACHED BEFORE IT REACHED THE TUBE. WHEN IT WAS WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE COIL WAS STRETCHED. THE COIL WAS RETAINED IN THE MICROCATHETER, AND THERE WAS A STRETCHED WIRE AT THE TIP END OF THE SUPPORT GUIDE WIRE. THE MICROCATHETER AND THE COIL WERE REPLACED TO CONTINUE FILLING, AND THE OPERATION ENDED SMOOTHLY. THERE WAS NO DAMAGE TO THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047512 ↗
• MalfunctionJul 13, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A ECHELON10 CATHETER TIP WAS DAMAGED AND AN AXIUM QC-1.5-2-HELIX COIL COULD NOT BE DETACHED. ANEURYSM EMBOLIZATION. THE MICROCATHETER WAS SHAPED AND FOUND THAT THE TIP WAS DAMAGED. REPLACING WITH ANOTHER MICROCATHETER AND WAS SUCCESSFULLY IN PLACE. AFTER FORMING A HOOP, QC-1.5-2-HELIX WAS SELECTED FOR FILLING. THE SPRING COIL COULD NOT BE DETACHED, REPLACED WITH ANOTHER ONE AND THE FILLING WAS SUCCESSFUL. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE OPHTHALMIC ARTERY. THE MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS FEMORAL ARTERY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009624 ↗

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