AxiumRecalls & reported problems across all models

We found 28 models of Axium by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2017 and Apr 2, 2026 — classified as 5 deaths, 1 injury, 65 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (35 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Axium problems

Axium models

28 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Axium QC-7-30-3D

  Device, Vascular, for Promoting Embolization
  2 deaths7 reports
• Axium QC-8-30-3D

  Device, Vascular, for Promoting Embolization
  6 reports
• Axium QC-9-30-3D

  Device, Vascular, for Promoting Embolization
  6 reports
• Axium QC-7-20-3D

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium QC-5-10-3D

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium QC-10-30-3D

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium QC-22-50-3D

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium QC-25-50-3D

  Device, Vascular, for Promoting Embolization
  1 death4 reports
• Axium QC-7-30-HELIX

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium QC-14-40-3D

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium QC-18-40-3D

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium QC-6-20-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium QC-5-15-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium QC-6-20-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium QC-8-20-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• AXIUM NC-4-10-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 deaths2 reports
• Axium QC-4-10-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-4-12-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-5-15-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-5-20-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-14-30-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-16-40-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-4-8-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-6-15-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-10-20-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-16-40-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium QC-20-50-3D

  Device, Vascular, for Promoting Embolization
  1 report
• AXIUM PC-7-20-3D

  Device, Vascular, for Promoting Embolization
  1 report

Recent Axium adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Break; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL BROKE INSIDE THE ECHELON CATHETER THEREFORE IT COULD NOT BE PUSHED. THE COIL WAS STUCK IN THE CATHETER. THE CATHETER WAS DAMAGED. THE COIL WAS DAMAGED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766902 ↗
• MalfunctionNov 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE FIRST COIL PREMATURELY DETACHED AND THE PUSHWIRE SEPARATED. CONTRADICTORILY, IT WAS STATED THAT THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE OF EITHER COIL. THE COIL MANAGED TO BE PLACED, BUT IT WAS UNKNOWN IF IT WAS IN THE INTENDED PLACE. THE FIRST COIL HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY, BUT THE SECOND COIL WAS STUCK. THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COILS WERE PULLED BACK INSIDE DURING HYDRATION. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PATIENT HAD BEEN UNDERGOING TREATMENT FOR A BASILAR TIP ANEURYSM, WHICH WAS MORE THAN 20MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792501 ↗
• MalfunctionOct 24, 2024Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 6 MM AND NECK DIAMETER 3 MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND THE VESSEL TORTUOSITY WAS MODERATE. WHEN THE SURGEON USED THE COIL TO EMBOLIZE THE MIDDLE CEREBRAL ARTERY ANEURYSM, HE USED THE QC5-10-3D COIL. THE EMBOLIZATION WAS SATISFACTORY, AND WHEN HE WAS READY TO DETACH THE COIL, HE USED THE ALTERNATIVE DETACHMENT METHOD AND BROKE THE SPARE DETACHMENT POINT BY HAND AND FOUND THAT THE COIL WAS NOT DETACHED. HE PULLED OUT THE DETACHMENT WIRE FOR OBSERVATION AND FOUND THAT THE PROXIMAL END OF THE DETACHMENT WIRE WAS SHORT AND BROKE IN ADVANCE. THE PHYSICIAN USED STERILE NEEDLE-NOSED PLIERS TO TWIST OFF THE PROXIMAL PUSHER ROD, FOUND THE TAIL END OF THE BROKEN DETACHMENT WIRE IN THE PUSHER ROD AND PULLED IT OUT, AND THEN THE DETACHMENT WAS SUCCESSFUL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. A MANUAL ATTEMPT AT DETACHMENT VIA HYPO

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 20521670 ↗
• MalfunctionOct 23, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STUCK IN THE CENTER OF THE CATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED RIGHT IC-PC ANEURYSM WITH A SACCULAR MORPHOLOGY. SIZE OF ANEURYSM: MAXIMUM DIAMETER OF ANEURYSM 20 MM AND NECK DIAMETER OF ANEURYSM 7 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. DURING INSERTION OF THE COIL INTO THE CATHETER AND GUIDANCE TO THE ANEURYSM, THE COIL COULD NOT ADVANCE AT THE TIMING WHEN IT WAS PO SITIONED AT ABOUT HALF THE CATHETER LENGTH. IT DID NOT ADVANCE EVEN WHEN IT WAS PULLED AND PUSHED AGAIN; IT WAS COLLECTED. LOOKING AT THE COLLECTED COIL, IT WAS UNRAVELED. A THROMBUS FORMED IN THE CATHETER, AND THIS MIGHT HAVE CAUSED THE COIL RESISTANCE. THE COIL WAS REMOVED WHILE IT WAS STUCK, SO IT WAS PREDICTED THAT IT MIGHT HAVE BEEN UNRAVELED. IT WAS UNKNOWN IF THE CATHETER WAS DAMAGED. DAMAGE TO THE COIL WAS NOTED. COIL SEPARATION/BREAK/PREMATURE DETACHMENT WAS NOTED. THE COIL WAS REMOVED OUTSIDE THE BODY BY THE WIRE BEING PULLED AND COLLECTED. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519440 ↗
• MalfunctionSep 9, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO HEALTH IMPACT. THE CAUSE OF THE COIL BREAK WAS NOTED THAT THE BLOOD CLOT WAS FORMED IN THE CATHETER AND CAUSED THE COIL TO GET STUCK. IT WAS SUSPECTED THAT THE COIL WAS UNLABELED BECAUSE IT WAS PULLED OUT IN A STUCK STATE. THE COIL WAS ABLE TO ADVANCE FROM THE SHEATH INTO THE MICROCATHETER, BUT IT BECAME DIFFICULT TO BE GUIDED IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 20171485 ↗
• MalfunctionSep 5, 2024Break; No Apparent Adverse Event; Physical Resistance/Sticking; Break; No Apparent Adverse Event; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL WAS STUCK IN THE CATHETER. DURING INSERTION OF THE COIL INTO THE CATHETER AND GUIDING IT TO THE ANEURYSM, THE COIL COULD NOT ADVANCE AT THE TIMING WHEN IT APPROACHED ABOUT HALF THE CATHETER LENGTH. IT DID NOT ADVANCE EVEN WHEN IT WAS PULLED AND PUSHED AGAIN; IT WAS COLLECTED. LOOKING AT THE COLLECTED COIL, IT WAS BROKEN. A THROMBUS FORMED IN THE CATHETER, SO IT MIGHT HAVE BEEN A COIL STUCK. THE COIL WAS REMOVED WHILE IT WAS STUCK, SO IT WAS PREDICTED THAT IT MIGHT HAVE BEEN BROKEN. THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID-PC LOCATION. THE ANEURYSM MAX DIAMETER WAS 20MM AND THE NEKC DIAMETER WAS 7MM. PATIENT BLOOD FLOW SPEED WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ANCILLARY DEVICES: SL-10 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154042 ↗
• MalfunctionApr 3, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COILS (LOT 225631674 AND LOT 226051945) WERE STRETCHED AND SUCCESSFULLY IMPLANTED AFTER REPLACEMENT. THE SPRING COIL (LOT 225062459) WAS NOT DETACHED SMOOTHLY, BUT IT WAS SUCCESSFULLY DETACHED AND IMPLANTED AFTER REPLACEMENT. 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 A CORONARY FISTULA. 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 19032986 ↗
• MalfunctionMar 1, 2024Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE STRETCH WAS NOT DETERMINED. DUE TO NORMAL PROCESS OPERATION, IT WAS SUSPECTED THAT THERE WAS A QUALITY CONTROL ISSUE WITH THE SPRING COIL. THE AXIUM COIL DETACHED ON IT'S OWN. THERE WERE NOT ANY ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE COIL WAS IMPLANTED. A TOTAL OF 36 COILS WERE IMPLANTED BEFORE AND AFTER THIS COIL MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816390 ↗
• MalfunctionJan 25, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT DETACH AFTER IT WAS PLACED INTO THE ANEURYSM DESPITE USING THE MANUAL BREAK.  IT WAS REPORTED NON-DETACHMENT OCCURRED. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM WITH A MAX DIAMETER OF 9 MM AND A 9 MM NECK DIAMETER. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584118 ↗
• MalfunctionOct 12, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ENTIRE BROKEN AXIUM COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919217 ↗
• MalfunctionSep 29, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT POOR DETACHMENT OCCURRED. THE COIL COULD NOT BE DETACHED SO IT WAS REMOVED. IT WAS UNKNOWN HOW MANY TIMES THE PHYSICIAN ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. IT WAS UNKNOWN IF THERE WAS ANY ISSUE WITH THE INSTANT DETACHER. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTION IN THE PACKAGE INSERT. ANCILLARY DEVICES INCLUDE A SHEATH, ROADMASTER/GOODMAN GUIDE CATHETER, SL10 MICROCATHETER, AND SYNCHRO GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844428 ↗
• MalfunctionJul 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE COIL WAS WITHDRAWN FROM THE ANEURYSM TO ADJUST ITS POSITION, IT COULD NOT BE PUSHED. THE COIL WAS STUCK IN THE MICROCATHETER. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 7MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE RESISTANCE WAS LOCATED IN THE MIDDLE OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343533 ↗
• MalfunctionApr 25, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE (STRETCH) THAT WAS FOUND. IT WAS UNKNOWN HOW MANY ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. MANY MANUAL ATTEMPTS WERE MADE TO DETACH THE COIL. 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 16807865 ↗
• MalfunctionFeb 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  NEW INFORMATION WAS RECEIVED. THE QC-14-40-3D DETACHABLE SPRING COIL WAS DETACHED WHEN IT WAS TAKEN OUT OF THE PROTECTIVE SHEATH. THE OPERATOR THOUGHT THIS WAS A PRODUCT QUALITY PROBLEM AND REQUESTED TO RETURN IT. PART OF THE COIL DID NOT FRACTURE AND SEPARATE FROM THE REST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311061 ↗
• MalfunctionDec 8, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. PRIOR TO COIL NON-DETACHMENT, NO OTHER PROBLEMS WERE ENCOUNTERED EXCEPT PUSH RESISTANCE. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939832 ↗

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