Axium Detachable Coil System QC-5-15-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536037816), received between Apr 1, 2022 and Sep 2, 2026 — classified as 1 death, 14 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566171 ↗
• MalfunctionAug 12, 2026Incomplete or Missing Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229488 ↗
• MalfunctionMay 6, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE DURING DELIVERY IN THE ECHELON 10 MICROCATHETER AND THE P USHER WAS KINKED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT POSTERIOR COMMUNICATING ARTERY SEGMENT (PCOM) RUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 2.3MM. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO ISSUE DURING TESTING OF THE DEVICE. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE ECHELON 10 MICROCATHETER WAS POSITIONED AND DELIVERY OF THE FIRST COIL (QC-5-15-3D, LOT: 227937272) WAS INITIATED. HOWEVER, RESISTANCE WAS SIGNIFICANT AND THE MIDDLE SEGMENT OF THE PUSHER KINKED SO THE COIL WAS REMOVED. AS ANOTHER AXIUM COIL OF THE SAME SIZE/MODEL WAS NOT AVAILABLE, A DIFFERENT MANUFACTURER'S DEVICE WAS USED INSTEAD AND THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL DID COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107335 ↗
• MalfunctionMar 10, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE COIL EMBOLIZATION WAS COMPLETED, DURING DETACHMENT, THE OPERATOR MANUALLY BROKE OFF THE DETACHMENT AREA BUT COULD NOT FIND THE DETACHMENT WIRE. ONLY BY USING SURGICAL FORCEPS TO BREAK OFF THE MIDDLE SECTION OF THE PUSH ROD AND REMOVE THE DETACHMENT WIRE COULD THE COIL BE SUCCESSFULLY DETACHED. THE PRODUCT WAS REPLACED WITH A 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 A RUPTURED, SACCULAR, RIGHT OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 7 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557779 ↗
• DeathSep 5, 2025Stretched; Unintended Movement; Stretched; Unintended Movement

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE INVOLVING THE AXIUM QC COIL, THE DEVICE EXPERIENCED COIL STRETCH. IT WAS REPORTED THAT THE COIL WAS IMPLANTED, AND THE PATIENT WAS "RIP". IT WAS UNKNOWN IF THERE WAS ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS CONFIRMED THE PATIENT PASSED AWAY. THERE CAUSE OF DEATH WAS UNKNOWN AT THIS TIME, THOUGH IT WAS NOTED THAT THERE IS NO CURRENT EVIDENCE TO SUGGEST THAT THE DEATH WAS RELATED TO THE MEDTRONIC DEVICE OR THERAPY. THE PATIENT HAD UNDERWENT ANGIOGRAM AND COIL EMBOLIZATION FOR A 7×5×4 MM IRREGULAR, LOBULATED, WIDE-NECKED ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM (NECK 3.5 MM), ARISING FROM LEFT A1 ACA SEGMENT. THE COIL STRETCH OCCURRED DURING THE PROCEDURE WHEN ATTEMPTING TO REMOVE A PROMINENT COIL LOOP PROTRUDING INTO THE LEFT A1/A2 JUNCTION. THE STRETCHED COIL WAS ULTIMATELY REMOVED USING COMBINED ASPIRATION AND A TIGERTRIEVER XL AND WAS NOT IMPLANTED. THE COIL STRETCH OCCURRED DUE TO REPEATED MANIPULATION AND TRACTION DURING MULTIPLE RETRIEVAL ATTEMPTS AFTER BALLOON-ASSISTED ADJUSTMENT FAILED TO RESOLVE THE PROMINENT LOOP AT THE A1/A2 JUNCTION. TH

  Patient problems: Insufficient Information; Ischemia Stroke; Obstruction/Occlusion; Vasoconstriction

  MAUDE report 22986603 ↗
• MalfunctionMar 19, 2025Break; Stretched; Separation Failure; Break; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL DETACHMENT FAILED. THE SURGEON DISCOVERED THAT THE COIL FAILED TO BE DETACHED WHEN DETACHING THE COIL, SO THEY REMOVED THE SPRING COIL THAT FAILED TO BE DETACHED AND REPLACED IT WITH A NEW ONE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643875 ↗
• MalfunctionMar 10, 2025Break; Stretched; Separation Failure; No Apparent Adverse Event; Break; Stretched; Separation Failure; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THEY DID NOT USE THE INSTANT DETACHER. 2 ATTEMPTS WERE MADE TO DETACH WITH THE MANUAL MENTHOD. THE BACKUP HAND-BREAKING DETACHMENT AREA BROKE, AND THE DETACHMENT WIRE COULD NOT BE PULLED OUT. THERE WAS NO DAMAGE TO THE PUSHWIRE OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560594 ↗
• MalfunctionNov 18, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS ATTEMPTED TO BE DETACHED WITH THE DETACHER 8 TIMES. THERE WAS NO ATTEMPT WITH THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20713577 ↗
• MalfunctionJun 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE IN THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 13 MM AND A 7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE FACILITY TREATED A CASE OF INTRACRANIAL ANEURYSM. AFTER THE ANGIOGRAPHIC DIAGNOSIS, 6 GAIDING + ECHELON MIC ROCATHETER + JOHNSON & JOHNSON 21 MICROCATHETER WERE USED TO ESTABLISH ACCESS.  AFTER THE STENT CATHETER AND STUFFING CATHETER WERE IN PLACE, DELIVERED INTO THE LVIS STENT AND SEMI-DEPLOYMENT, AND QC3D COIL 18-40 WAS SELECTED TO PLACE INTO THE TUMOR AND FORM HOOP. AFTER ANGIOGRAPHY, TWO QC3D COILS 14-40, ONE QC3D COIL 12-40, TWO QC3D COILS 7-30, AND TWO PRIME3D COILS 6-20 WERE SELECTED AND PLACED INTO THE TUMOR. AFTER ANGIOGRAPHY, SELECTED 5-15 QC3D COIL. DURING THE PROCESS OF ENTERING THE ECHELON-10 MICROCATHETER, THE SPRING COIL WAS DIFFICULT TO DELIVERED INTO IT AND IT COULD NOT BE PUSHED. AFTER THE RADIOGRAPHY TUMOR WAS NOT DEVELOPED, THE STENT WAS DEVELOPED AND THE SURGERY WAS OVER. THE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588409 ↗
• MalfunctionMay 20, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT ONE AXIUM COIL ENCOUNTERED RESISTANCE IN THE ECHELON CATHETER AND ANOTHER AXIUM COIL WAS UNABLE TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN C4 WITH A MAX DIAMETER OF 4 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM COIL (LOT # 225790102) WAS UNABLE TO ENTER MICROCATHETER, WITHDREW. REPLACEMENT COMPLETED SURGERY. THE AXIUM COIL WITH LOT # 227626173 WAS UNABLE TO DETACH, WITHDREW AS A WHOLE. COMPLETED THE SURGERY BY REPLACING IT WITH A NEW COIL. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER TWO TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WERE TWO MANUAL ATTEMPTS MADE AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351263 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS FOUND PREMATURELY DETACHED WHEN THE OPENED FROM THE PACKAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM IN THE ANTERIOR CEREBRAL ARTERY WITH A MAX DIAMETER OF 6.8 MM AND A 4.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PATIENT HAD AN ANTERIOR CEREBRAL ANEURYSM AND WAS SCHEDULED FOR STENT-ASSISTED ANEURYSM EMBOLIZATION. DURING THE OPERATION, WHEN THE SPRING COIL PACKAGE WAS OPENED, IT WAS FOUND THAT THE SPRING COIL HAD BEEN DETACHED. THE SPRING COIL WAS REPLACED AND IMPLANTED UNTIL THE SURGERY WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. IT WAS REPORTED THE COIL HAD BEEN DETACHED AFTER UNPACKING. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351171 ↗
• MalfunctionApr 3, 2024Stretched; Unintended Movement; Stretched; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE STRETCH WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032253 ↗
• MalfunctionFeb 7, 2024Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking; Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ONE AXIUM COIL ENCOUNTERED RESISTANCE WITH THE SHEATH AND ANOTHER AXIUM COIL ENCOUNTERED RESISTANCE WITH THE CATHETER.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 6.8 MM AND A 4.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE QC-6-20-3D COULD NOT BE PUSHED IN THE MICROCATHETER (190-5091-150, LOT NUMBER: B527442). THE SURGEON WITHDREW FROM THE BODY AND FOUND THAT THE PROTECTIVE SHEATH COULD NOT BE PUSHED OUT. AFTERWARDS, REPLACED WITH A QC-6-20-HELIX COIL AND IT COULD BE PUSHED SMOOTHLY. IT WAS REPORTED THE COIL ENCOUNTERED RESISTANCE/STUCK IN SHEATH. CONTINUING TO STUFF THE QC-5-15-3D COIL, IT WAS FOUND THAT THE RESISTANCE OF THE COIL AT THE PROXIMAL END OF THE MICROCATHETER WAS VERY LARGE. WHEN THE COIL WAS REMOVED FROM THE BODY AND CHECKED, IT WAS FOUND THAT THE COIL BODY WAS NO LONGER SHAPED AND COULD NOT BE USED. AFTERWARDS, REPLACED WITH A NEW COIL AND IT COULD BE PUSHED SMOOTHLY IN THE CATHETER. IT WAS REPORTED THE COIL ENCOUNTERED RESISTANCE/STUCK IN CATHETER. THE COIL W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663828 ↗
• MalfunctionJul 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON SELECTED A SYNCRHO-14, ECHELON-10 MICROCATHETER, AND A QC-5-15-3D FOR THE FIRST EMBOLIZATION. THE SPRING COIL SELF-DETACHED IN THE ECHELON-10. THE COIL WAS REPLACED WITH THE SAME MODEL, THERE WAS NO ABNORMALITY WITH THE SECOND COIL AND THE SPRING DETACHED CORRECTLY. THERE WERE NO SURGICAL OR MEDICINAL INTERVENTIONS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE, HOWEVER, A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. 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 POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070384 ↗
• MalfunctionApr 1, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THREE AXIUM COILS DID NOT DETACH INITIALLY. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED AMORPHOUS ANEURYSM IN THE ACOMM LOCATION. THE MAX DIAMETER WAS 9MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS SEVERE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  THE MICROCATHETER WAS A COMPETITOR'S PRODUCT. THE COILS WERE DETACHED. WHEN PULLING BACK THE PUSHER WIRE THE DETACHER MARKER ON THE PUSHER WIRE MOVED BACK AND THE COIL DIDN'T. THEN AFTER ABOUT 1 CM THE COIL STARTED TO COME BACK WHEN PULLING THE PUSHER WIRE. REPOSITIONED THE MICROCATHETER DISTALLY AND PROXIMALLY. AND TRIED DETACHING 2 MORE TIMES. THEN BROKE THE PUSHER WIRE. AND STILL THE COIL WOULD COME BACK AFTER PULLING BACK THE PUSHER. EVENTUALLY THE COIL DETACHED AFTER THE MICROCATHETER MOVED AND PUSHERWIRE PUSHED PULLED NUMEROUS TIMES. 3 ATTEMPTS TO DETACH WITH THE INSTANT DETACHER. DID NOT TRY ANOTHER INSTANT DETACHER. 1 ATTEMPT WAS MADE TO DETACH VIA A HYPOTUBE. NO ISSUE WITH THE INSTANT DETACHER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979921 ↗

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