AxiumTMRecalls & reported problems across all models

We found 139 models of AxiumTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 832 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2017 and Aug 11, 2026 — classified as 11 deaths, 49 injuries, 772 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (340 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

AxiumTM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 27, 2022Open, Classified

   Due to incorrect size and configuration labeling of the detachable coil system.

   Z-1261-2022 · Root cause: Labeling Change Control · names 2 of these models · Recall details · FDA record ↗

Most reported AxiumTM problems

AxiumTM models

139 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• AxiumTM QC-4-12-HELIX

  Device, Vascular, for Promoting Embolization
  1 recall2 reports
• AxiumTM QC-10-30-3D

  Device, Vascular, for Promoting Embolization
  1 recall2 reports
• AxiumTM APB-3-6-3D-ES

  Device, Vascular, for Promoting Embolization
  36 reports
• AxiumTM APB-2-4-3D-ES

  Device, Vascular, for Promoting Embolization
  31 reports
• AxiumTM APB-3-4-3D-ES

  Device, Vascular, for Promoting Embolization
  27 reports
• AxiumTM APB-4-12-3D-SS

  Device, Vascular, for Promoting Embolization
  1 death22 reports
• AxiumTM APB-2.5-4-3D-ES

  Device, Vascular, for Promoting Embolization
  22 reports
• AxiumTM APB-3.5-6-3D-ES

  Device, Vascular, for Promoting Embolization
  22 reports
• AxiumTM APB-1.5-2-3D-ES

  Device, Vascular, for Promoting Embolization
  20 reports
• AxiumTM APB-2-2-3D-ES

  Device, Vascular, for Promoting Embolization
  19 reports
• AxiumTM APB-5-10-3D-SS

  Device, Vascular, for Promoting Embolization
  18 reports
• AxiumTM APB-2-6-HX-ES

  Device, Vascular, for Promoting Embolization
  18 reports
• AxiumTM APB-2-8-HX-ES

  Device, Vascular, for Promoting Embolization
  18 reports
• AxiumTM APB-2-3-3D-ES

  Device, Vascular, for Promoting Embolization
  1 death18 reports
• AxiumTM APB-5-15-3D-SS

  Device, Vascular, for Promoting Embolization
  1 death17 reports
• AxiumTM APB-1-2-3D-ES

  Device, Vascular, for Promoting Embolization
  17 reports
• AxiumTM APB-4-10-3D-SS

  Device, Vascular, for Promoting Embolization
  15 reports
• AxiumTM APB-4-8-3D-SS

  Device, Vascular, for Promoting Embolization
  15 reports
• AxiumTM APB-2.5-6-3D-ES

  Device, Vascular, for Promoting Embolization
  15 reports
• AxiumTM APB-3-8-3D-ES

  Device, Vascular, for Promoting Embolization
  15 reports
• AxiumTM APB-1-1-HX-ES

  Device, Vascular, for Promoting Embolization
  14 reports
• AxiumTM APB-1-2-HX-ES

  Device, Vascular, for Promoting Embolization
  14 reports
• AxiumTM APB-6-15-3D-SS

  Device, Vascular, for Promoting Embolization
  1 death13 reports
• AxiumTM APB-6-20-3D-SS

  Device, Vascular, for Promoting Embolization
  1 death13 reports
• AxiumTM APB-3-8-HX-ES

  Device, Vascular, for Promoting Embolization
  13 reports
• AxiumTM APB-3-10-HX-ES

  Device, Vascular, for Promoting Embolization
  2 deaths13 reports
• AxiumTM APB-1.5-4-3D-ES

  Device, Vascular, for Promoting Embolization
  13 reports
• AxiumTM APB-2-3-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  12 reports
• AxiumTM APB-2-4-HX-ES

  Device, Vascular, for Promoting Embolization
  12 reports
• AxiumTM APB-3.5-8-3D-ES

  Device, Vascular, for Promoting Embolization
  12 reports
• AxiumTM APB-1.5-3-HX-ES

  Device, Vascular, for Promoting Embolization
  11 reports
• AxiumTM APB-2.5-6-HX-ES

  Device, Vascular, for Promoting Embolization
  11 reports
• AxiumTM APB-3-6-HX-ES

  Device, Vascular, for Promoting Embolization
  11 reports
• AxiumTM APB-1.5-4-HX-ES

  Device, Vascular, for Promoting Embolization
  10 reports
• AxiumTM APB-4-12-HX-SS

  Device, Vascular, for Promoting Embolization
  9 reports
• AxiumTM APB-1.5-2-HX-ES

  Device, Vascular, for Promoting Embolization
  9 reports
• AxiumTM APB-1-4-3D-ES

  Device, Vascular, for Promoting Embolization
  9 reports
• AxiumTM APB-1.5-3-3D-ES

  Device, Vascular, for Promoting Embolization
  9 reports
• AxiumTM QC-2-6-3D

  Device, Vascular, for Promoting Embolization
  9 reports
• AxiumTM APB-5-20-HX-SS

  Device, Vascular, for Promoting Embolization
  8 reports
• AxiumTM APB-1-3-HX-ES

  Device, Vascular, for Promoting Embolization
  8 reports
• AxiumTM APB-4-6-3D-SS

  Device, Vascular, for Promoting Embolization
  7 reports
• AxiumTM QC-2-6-3D

  Device, Vascular, for Promoting Embolization
  7 reports
• AxiumTM APB-2.5-4-HX-ES

  Device, Vascular, for Promoting Embolization
  7 reports
• AxiumTM APB-3-4-HX-ES

  Device, Vascular, for Promoting Embolization
  7 reports
• AxiumTM QC-3-8-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• AxiumTM QC-8-30-3D

  Device, Vascular, for Promoting Embolization
  7 reports
• AxiumTM PC-2-8-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• AxiumTM APB-2-2-HX-ES

  Device, Vascular, for Promoting Embolization
  6 reports
• AxiumTM APB-1-3-3D-ES

  Device, Vascular, for Promoting Embolization
  6 reports
• AxiumTM APB-3.5-10-3D-ES

  Device, Vascular, for Promoting Embolization
  6 reports
• AxiumTM APB-5-8-3D-SS

  Device, Vascular, for Promoting Embolization
  1 death5 reports
• AxiumTM QC-1.5-2-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• AxiumTM QC-3-8-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• AxiumTM APB-4-8-HX-SS

  Device, Vascular, for Promoting Embolization
  4 reports
• AxiumTM APB-5-15-HX-SS

  Device, Vascular, for Promoting Embolization
  1 death4 reports
• AxiumTM APB-6-20-HX-SS

  Device, Vascular, for Promoting Embolization
  4 reports
• AxiumTM QC-2-4-3D

  Device, Vascular, for Promoting Embolization
  4 reports
• AxiumTM APB-2.5-8-HX-ES

  Device, Vascular, for Promoting Embolization
  4 reports
• AxiumTM QC-2-6-HELIX

  Device, Vascular, for Promoting Embolization
  4 reports
• AxiumTM QC-3-6-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• AxiumTM QC-7-30-3D

  Device, Vascular, for Promoting Embolization
  4 reports
• AxiumTM APB-4-10-HX-SS

  Device, Vascular, for Promoting Embolization
  3 reports
• AxiumTM APB-6-10-3D-SS

  Device, Vascular, for Promoting Embolization
  3 reports
• AxiumTM PC-2-6-3D

  Device, Vascular, for Promoting Embolization
  3 reports
• AxiumTM APB-2.5-3-HX-ES

  Device, Vascular, for Promoting Embolization
  3 reports
• AxiumTM QC-2-8-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• AxiumTM QC-2-4-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• AxiumTM QC-4-12-3D

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

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

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

  Device, Vascular, for Promoting Embolization
  3 reports
• AxiumTM PC-2-6-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• AxiumTM PC-3-8-HELIX

  Device, Vascular, for Promoting Embolization
  3 reports
• AxiumTM PC-3-8-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• AxiumTM APB-5-10-HX-SS

  Device, Vascular, for Promoting Embolization
  1 death2 reports
• AxiumTM QC-1.5-1-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• AxiumTM QC-2-6-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• AxiumTM QC-2-8-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• AxiumTM QC-3-10-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• AxiumTM QC-3-8-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• AxiumTM QC-3-4-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• AxiumTM QC-3-10-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• AxiumTM QC-4-8-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• AxiumTM QC-12-40-3D

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

  Device, Vascular, for Promoting Embolization
  2 reports
• AxiumTM NC-2-3-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• AxiumTM NC-3-8-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• AxiumTM APB-4-6-HX-SS

  Device, Vascular, for Promoting Embolization
  1 report
• AxiumTM APB-6-12-HX-SS

  Device, Vascular, for Promoting Embolization
  1 report
• AxiumTM NC-3-4-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 death1 report
• AxiumTM QC-1.5-2-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• AxiumTM QC-1.5-3-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• AxiumTM QC-2.5-6-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• AxiumTM QC-3.5-12-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• AxiumTM QC-3-4-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• AxiumTM QC-3-6-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• AxiumTM QC-3-8-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• AxiumTM QC-4-12-3D

  Device, Vascular, for Promoting Embolization
  1 report
• AxiumTM APB-3-6-3D-ES

  Device, Vascular, for Promoting Embolization
  1 report

Recent AxiumTM adverse event reports

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

• MalfunctionAug 11, 2026Material Deformation; Packaging Problem

  Medtronic received a report that an Axium coils were kinked. It was reported that during the preparation stage, when the product was being removed from the sheath, the delivery wire was kinked. Damage was observed on the pusher at the proximal section. Considering that it is a wire¿type coils, it was not used and was replaced with an equivalent product. All devices were prepared as indicated in the IFU. No patient complications were associated with this event. Additional information was received that the treated aneurysm was approximately 3 mm located at the anterior communicating artery. There was nothing in particular regarding damage or evidence of tampering to device packaging. The proximal end of the¿push wire¿was secured in the guidewire clip (black rubber stopper) when the¿package was¿opened.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201962 ↗
• MalfunctionJul 15, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25828396 ↗
• MalfunctionJun 1, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN AN ATTEMPT WAS MADE TO INSERT THE AXIUM PRIME BARE 3D COIL INTO THE NON-MEDTRONIC MICROCATHETER, THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH, HOWEVER, IT GOT STUCK IN THE HUB AND WOULDN'T GO IN. WHEN A DIFFERENT COIL WAS USED, IT WENT IN SMOOTHLY, SO THE PROCEDURE WAS PERFORMED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT M1 SEGMENT ANEURYSM 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 MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE COIL OR CATHETER. ANCILLARY DEVICES INCLUDED SL-10 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. IT WAS ASKED BUT UNKNOWN IF THERE WAS ANY CAUSES OR CONTRIBUTING FACTORS FOR THE RESISTANCE WAS IDENTIFIED. THE INFORMATION HAS BEEN CONFIRMED/PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351013 ↗
• MalfunctionMay 21, 2026Break

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ARTERIOVENOUS MALFORMATIONS OR ARTERIOVENOUS FISTULAS, THE LESION GRADE IS UNKNOWN. THE FOCI WAS NOT LOCATED IN THE FUNCTIONAL AREA OF THE BRAIN (ELOQUENT AREA). IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS SLOW AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING TREATMENT FOR D-AVF, AFTER INSERTING MORE THAN 10 COILS, AN ATTEMPT WAS MADE TO INSERT THE AXIUM COIL A PB-1.5-4-3D-ES; HOWEVER, THE BREAK INDICATOR WAS FOUND TO BE BROKEN, AT THE PROXIMAL PUSHER. THE COIL WAS REPLACED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249188 ↗
• MalfunctionMay 20, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM LOCATED ON THE RIGHT BOUTHILLIER CLASSIFICATION C1 WITH A MAX DIAMETER OF 6MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO PERFORM EMERGENCY DETACHMENT USING THE DETACHER, BUT SEPARATION COULD NOT BE ACHIEVED, SO IT WAS COLLECTED IN THE CATHETER, SO THE SAME PRODUCT WITH THE SAME LOT WAS USED, BUT THE SAME EVENT OCCURRED, SO IT WAS SWITCHED TO A COIL FROM ANOTHER MANUFACTURER AND THE TREATMENT WAS FINISHED. THERE WAS NO HEALTH IMPACT. TWO COILS AND ONE DETACHER WERE REPORTED. IT WAS STATED THAT THERE WAS POOR WITHDRAWAL. THE PHYSICIAN TRIED 1 TIME TO DISARM THE COIL USING THE INSTANT DETACHER. THERE WAS 1 MANUAL ATTEMPT VIA HYPO TUBE MADE. ALL DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234396 ↗
• MalfunctionMay 13, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT ANTERIOR COMMUNICATING ARTERY (ACA) ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 2.3 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE SUBJECT PRODUCT WAS USED FOR THE FOURTH COIL. EMBOLIZATION WAS COMPLETED AND DETACHMENT WAS PERFORMED WITH INSTANT DETACHER ID1, BUT IT DID NOT DETACH AND AN EVENT OCCURRED IN WHICH THE COIL CAME BACK ATTACHED TO THE DELIVERY WIRE, WHICH IT LED A POOR DISLODGEMENT. A SECONDARY DETACHMENT AT HAND WAS ATTEMPTED BUT THERE WAS NO CHANGE AND DETACHMENT DID NOT OCCUR, SO THE ENTIRE COIL WAS RE-SHEATHED INTO THE PHENOM17MICROCATHETER (MC) AND RETRIEVED TOGETHER WITH THE MC. THE FIRST TO THIRD AXIUM COILS WERE DETACHED WITH THE SAME ID1, SO THE PHYSICIAN JUDGED THAT THIS WAS NOT AN ID1 MALFUNCTION. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE INSTANT DETACHER FIVE OR MORE TIMES WITHOUT SUCCESS. NO ATTEMPT WAS MADE TO WITHDRAW OR DETACH THE COIL USING ANOTHER INSTANT DETACHER. A MANUAL REMOVAL ATTEMPT VIA THE HYPOTUBE WAS PERFORMED ONCE. ADDITIONAL INFORMATION WAS RECEI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166366 ↗
• MalfunctionApr 29, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING COIL EMBOLIZATION THROUGH A MICROCATHETER, WHEN DETACHMENT WAS ATTEMPTED, THE AXIUM PRIME COIL COULD NOT BE DETACHED PROPERLY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE FACILITY CONSIDERS IT TO BE A PRODUCT DEFECT OF EITHER THE COIL OR THE DETACHER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF A RUPTURED, SACCULAR, RIGHT IC (INTERNAL CAROTID) OPHTHALMIC SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 2 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). "POOR DISLODGEMENT" WAS NOTED. THREE ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. IT WAS UNKNOWN IF ANY MANUAL DETACHMENT ATTEMPTS WERE MADE VIA THE HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033900 ↗
• MalfunctionApr 24, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME BARE HX COIL DID NOT DETACH. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR AN EMERGENT TAKEDOWN OF AN OROPHARYNGEAL BLEED AT THE LEVEL OF THE RIGHT SUPERIOR THYROID. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE COIL WAS THE 4TH AXIUM COIL TO BE INTRODUCED FOR EMBOLIZATION TO THE TAKEDOWN OF THE OROPHARYNGEAL ARTERY, WITH OTHER AXIUM COILS PRIOR DETACHING WITHOUT ISSUE. AFTER THREE FAILED ATTEMPTS TO DETACH THE COIL USING THE INSTANT DETACHER, SLIGHT RETRACTION OF THE MICROCATHETER WAS PERFORMED TO SEE IF THAT WOULD HELP DETACH, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. ONE MANUALLY DETACHMENT WAS THEN ATTEMPTED AT THE MANUAL BREAK POINT ON THE COIL PUSHER WIRE, BUT THIS ATTEMPT WAS ALSO UNSUCCESSFUL. WITHOUT ISSUE, THE COIL WAS FULLY REMOVED AND REPLACED WITH ANOTHER COIL OF THE SAME MODEL AND LOT, DETACHING WITHOUT ISSUE. THE OROPHARYNGEAL ARTERY EMBOLIZATION WAS SUCCESSFULLY EMBOLIZED WITHOUT PATIENT COMPLICATIONS WITH A TOTAL OF ELEVEN AXIUM COILS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ALL AXIUM COILS WERE PREP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24985604 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 12 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS A COMPLAINT THAT THE RESISTANCE WAS STRONG WHEN REPLACING THE SHEATH WITH A CATHETER IN ORDER TO INSERT THE COIL. AFTER COLLECTING THE COIL AND FLUSHING IT, AN ATTEMPT WAS MADE TO INSERT IT AGAIN, BUT IT WAS THE SAME AS BEFORE. FROM THE HAND MOVEMENT, IT APPEARED HEAVY, AND ALTHOUGH THERE WAS NO BENDING AND ETC. IN THE DELIVERY WIRE, IT WAS THOUGHT TO BE SOME KIND OF MALFUNCTION, SO IT WAS REQUESTED TO BE COLLECTED. IT WAS CONFIRMED THAT THE COIL WAS DISLODGED EARLY IN THE VICINITY OF THE Y-CONNECTOR WHEN IT WAS RETURNED TO THE SHEATH. THE COIL AND DELIVERY WIRE WERE COLLECTED AS A SET. THE COIL WAS REMOVED FROM THE BODY. THERE WERE NO ADDITIONAL SURGICAL OR MEDICAL PROCEDURES PERFORMED. THERE WAS NO DEFORMATION OR DAMAGE TO THE DELIVERY PUSHER. THERE WAS RESISTANCE DURING DELIVERY. THERE WAS COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953701 ↗
• MalfunctionApr 8, 2026Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A KINK WAS OBSERVED IN THE PROXIMAL REGION OF THE AXIUM PRIME BARE PUSHWIRE. IN REGARDS TO WHEN THE KINK WAS OBSERVED, IT WAS REPORTED THAT IT WAS ALREADY "BROKEN" WHEN IT WAS OPENED FROM THE PACKAGE. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. THE PRODUCT WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR VA PAO (VERTEBRAL ARTERY PARENT ARTERY OCCLUSION). 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). CONTINUOUS FLUSHING WAS PERFORMED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817875 ↗
• MalfunctionApr 8, 2026Therapy Delivered to Incorrect Body Area; Retraction Problem; Detachment of Device or Device Component; Migration; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND REMAINS IN THE PATIENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PATIENT PRESENTED AS A SUBACUTE RUPTURE TO THE ANTERIOR CIRCULATION AND UPON ANGIOGRAPHY WAS DETERMINED TO BE A RUPTURED BLISTER ANEURYSM OF A FENESTRATED VESSEL CONNECTED BETWEEN THE TWO ANTERIOR CEREBRAL VESSELS AT THE MID A2 JUNCTION. ACCESSING THE LEFT INTERNAL CAROTID ARTERY (ICA) VIA A 6FR. ZEBRA GUIDE, AN EXCELSIOR SL-10 MICROCATHETER WAS GUIDED TO THE A2 FENESTRATION VIA AN ARISTOTLE 14 SOFT GUIDE WIRE TO THE SITE OF THE BLISTER ANEURYSM. THE PHYSICIAN ATTEMPTED TO INSERT A STRYKER TARGET NANO COIL 1X2 (REF# (B)(4), LOT# 25675817) INTO THE BLISTER ANEURYSM WITHOUT SUCCESS AND WAS REMOVED WITHOUT ISSUE. THE PHYSICIAN THEN ATTEMPTED TO TREAT THE BLISTER ANEURYSM WITH AN AXIUM PRIME EXTRA SOFT COIL 1 X 1, WITH THE INITIAL COIL LOOP ACCESSING THE BLISTER ANEURYSM, BUT THE PHYSICIAN WORRIED IT WOULD NOT STAY IN PLACE, THUS BEGAN TO RET RACT THE LOOP BACK INTO THE SL-10 MICROCATHETER. DURING RETRACTION OF THE AXIUM PRIME EXTRA SOFT COIL 1 X 1, THE COIL PREMATURELY DETACHED AND

  Patient problems: Foreign Body In Patient; Muscle Weakness/Atrophy

  MAUDE report 24817005 ↗
• MalfunctionMar 30, 2026Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE PROXIMAL END OF THE PUSHWIRE SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. IT WAS UNABLE TO BE CONFIRMED IF THERE WAS ANY DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DEVICE WAS NOT USED IN THE PATIENT AND WHEN THE PACKAGE WAS OPENED, IT WAS AS SEEN IN THE IMAGE. THE VESSEL TORTUOSITY IS UNKNOWN. THE CAUSES OR CONTRIBUTING FACTORS FOR THE BREAK WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721105 ↗
• MalfunctionMar 18, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING ANOTHER INSTANT DETACHER. THE PH YSICIAN ATTEMPTED TO DETACH THE COIL MANUALLY VIA THE HYPOTUBE. THE "DETACHER ERROR" STATED MEANS THEY WERE UNABLE TO DETACH THE COIL. THE "POOR DISLODGEMENT" MEANS DETACHMENT FAILURE. THE COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631148 ↗
• MalfunctionMar 12, 2026Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT IT WAS CLARIFIED THAT THE, "PROXIMAL END OF THE AXIUM COIL WIRE HAD ALREADY BEEN BROKEN" WAS IN REFERENCE TO SOME OTHER ISSUE. THE COIL DID NOT PREMATURELY SEPARATE FROM THE DELIVERY WIRE. PART OF THE PUSHWIRE DID NOT FRACTURE AND SEPARATE FROM THE REST. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSH WIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT IDENTIFIED. THE PROCEDURE COMPLETED BY REPLACING THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579351 ↗
• MalfunctionMar 10, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME ES 3D COIL DID NOT DETACH. DETACHMENT WAS ATTEMPTED TWICE USING THE INSTANT DETACHER BUT WAS UNSUCCESSFUL; ONE EMERGENCY DETACHMENT WAS ALSO ATTEMPTED BUT COULD NOT BE PERFORMED (WAS UNSUCCESSFUL). SINCE THE DEVICE COULD BE STORED IN THE CATHETER, THE ENTIRE CATHETER WAS REMOVED. IT WAS REPORTED THERE WERE NO DEFECTS WITH THE INSTANT DETACHER. THE COIL 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 AN UNRUPTURED, SACCULAR, LEFT INTERNAL CAROTID ARTERY (LT. ICA BOUTHILLIER CLASSIFICATION C5 CLINOID SEGMENT) ANEURYSM WITH A MAX DIAMETER OF 5 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558836 ↗

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