Axium Detachable Coil SystemRecalls & reported problems across all models

We found 69 models of Axium Detachable Coil System by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 288 adverse event reports in the FDA's MAUDE database, received between Sep 20, 2021 and Sep 3, 2026 — classified as 8 deaths, 15 injuries, 265 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (98 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 Detachable Coil System problems

Axium Detachable Coil System models

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

• Axium Detachable Coil System QC-2-4-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  27 reports
• Axium Detachable Coil System QC-2-6-3D

  Device, Vascular, for Promoting Embolization
  22 reports
• Axium Detachable Coil System QC-2-8-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  19 reports
• Axium Detachable Coil System QC-3-6-3D

  Device, Vascular, for Promoting Embolization
  19 reports
• Axium Detachable Coil System QC-1.5-2-HELIX

  Device, Vascular, for Promoting Embolization
  16 reports
• Axium Detachable Coil System QC-5-15-3D

  Device, Vascular, for Promoting Embolization
  1 death15 reports
• Axium Detachable Coil System QC-3-8-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  12 reports
• Axium Detachable Coil System QC-4-12-3D

  Device, Vascular, for Promoting Embolization
  11 reports
• Axium Detachable Coil System QC-2-4-HELIX

  Device, Vascular, for Promoting Embolization
  1 death8 reports
• Axium Detachable Coil System QC-7-30-3D

  Device, Vascular, for Promoting Embolization
  8 reports
• Axium Detachable Coil System QC-5-20-HELIX

  Device, Vascular, for Promoting Embolization
  2 deaths7 reports
• Axium Detachable Coil System QC-2.5-4-3D

  Device, Vascular, for Promoting Embolization
  6 reports
• Axium Detachable Coil System QC-12-40-3D

  Device, Vascular, for Promoting Embolization
  6 reports
• Axium Detachable Coil System QC-2-6-HELIX

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium Detachable Coil System QC-4-12-HELIX

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium Detachable Coil System QC-7-30-HELIX

  Device, Vascular, for Promoting Embolization
  1 death5 reports
• Axium Detachable Coil System QC-8-30-3D

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium Detachable Coil System QC-3-6-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• Axium Detachable Coil System QC-3-8-HELIX

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium Detachable Coil System QC-3-4-3D

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium Detachable Coil System QC-20-50-3D

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

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium Detachable Coil System QC-2-3-HELIX

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

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium Detachable Coil System QC-10-30-HELIX

  Device, Vascular, for Promoting Embolization
  1 death3 reports
• Axium Detachable Coil System QC-4-8-3D

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium Detachable Coil System QC-1.5-3-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-1.5-4-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Axium Detachable Coil System QC-2-2-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-3-4-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-5-15-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-8-30-HELIX

  Device, Vascular, for Promoting Embolization
  2 deaths2 reports
• Axium Detachable Coil System QC-12-40-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-16-40-HELIX

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-4-10-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-5-10-3D

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

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-7-20-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-10-30-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-14-30-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-14-40-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System QC-16-40-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Detachable Coil System PC-16-40-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium™ Detachable Coil System PC-3-8-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium™ Detachable Coil System QC-3-6-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium™ Detachable Coil System QC-4-10-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-1.5-1-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium Detachable Coil System QC-4-10-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-9-30-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-10-20-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-12-30-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-18-40-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-20-40-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-20-50-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-2-2-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-2.5-6-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium Detachable Coil System QC-2.5-8-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-4-6-3D

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

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-7-15-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-8-20-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-9-30-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-18-40-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System QC-22-50-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System NC-3-4-HELIX

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System PC-3-8-HELIX

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium Detachable Coil System PC-2-6-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System PC-12-40-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Detachable Coil System PC-14-40-3D

  Device, Vascular, for Promoting Embolization
  1 report

Recent Axium Detachable Coil System adverse event reports

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

• MalfunctionSep 3, 2026Break; Detachment of Device or Device Component; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50587415 ↗
• 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 ↗
• MalfunctionJul 20, 2026Difficult or Delayed Positioning; Stretched; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882107 ↗
• MalfunctionJun 30, 2026Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS AXIUM COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED INTERNAL CAROTID ARTERY (ICA) BIFURCATION BRANCH ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH BOTH COILS USING ID-1-5 INSTANT DETACHER MULTIPLE TIMES. COIL DID NOT DETACH. PHYSICIAN USED THE BACK UP METHOD AND BROKE THE WIRE AND PULLED THE SUTURE AND BOTH COILS STILL DID NOT DETACH. THE SUTURE STRETCHED IN BOTH CASES. THE PHYSICIAN THEN PULLED HARDER AND MORE AGGRESSIVELY AND THE COILS FINALLY RELEASED. THERE WAS COIL NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES AND AN ADDITIONAL 3 TIMES WITH A SECOND INSTANT DETACHER. THERE WERE TWO MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. 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. ANCILLARY DEVICES INCLUDE A BENCHMARK BMK6F105, SL10 M00316890, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673369 ↗
• MalfunctionJun 30, 2026Difficult or Delayed Positioning; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED DIFFICULT PLACEMENT. IT WAS REPORTED THAT THE 2-6 COIL WAS ADVANCED BUT COULD NOT BE PLACED IN. IT WAS REPLACED WITH A 2-4 COIL, BUT THE 2-4 COIL SILL COULD NOT BE PLACED IN. THEN A 1.5 MM PRIME COIL WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THE DEVICES DID NOT JUMP DURING DEPLOYMENT AND THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS UNDER STRESS FOR THE 2-4 COIL, BUT NOT FOR THE 2-6 COIL, AND THE CATHETER MOVED DURING DEPLOYMENT. THE PHYSICIAN ROTATED THE 2-6 COIL DELIVERY PUSHER DURING THE PROCEDURE. THE ANEURYSM DID NOT RUPTURE. 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 WAS RECEIVED. THE VESSEL TORTUOSITY WAS NORMAL. THE PATIENT EXPERIENCED NO ADVERSE REACTIONS RELATED TO THE EVENT. THE CAUSES OR CONTRIBUTING FACTORS FOR THE DIFFICULT PLACEMENT AND CATHETER MOVEMENT COULD NOT BE DETERMINED. THE USED CATHETER WAS AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672610 ↗
• MalfunctionJun 30, 2026Difficult or Delayed Positioning; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED DIFFICULT PLACEMENT. IT WAS REPORTED THAT THE 2-6 COIL WAS ADVANCED BUT COULD NOT BE PLACED IN. IT WAS REPLACED WITH A 2-4 COIL, BUT THE 2-4 COIL SILL COULD NOT BE PLACED IN. THEN A 1.5 MM PRIME COIL WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THE DEVICES DID NOT JUMP DURING DEPLOYMENT AND THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS UNDER STRESS FOR THE 2-4 COIL, BUT NOT FOR THE 2-6 COIL, AND THE CATHETER MOVED DURING DEPLOYMENT. THE PHYSICIAN ROTATED THE 2-6 COIL DELIVERY PUSHER DURING THE PROCEDURE. THE ANEURYSM DID NOT RUPTURE. 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 WAS RECEIVED. THE VESSEL TORTUOSITY WAS NORMAL. THE PATIENT EXPERIENCED NO ADVERSE REACTIONS RELATED TO THE EVENT. THE CAUSES OR CONTRIBUTING FACTORS FOR THE DIFFICULT PLACEMENT AND CATHETER MOVEMENT COULD NOT BE DETERMINED. THE USED CATHETER WAS AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672579 ↗
• MalfunctionJun 26, 2026Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF ECHELON 10 CATHETER KICKBACK AND RESISTANCE WITH AN AXIUM COIL. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, ANTERIOR COMMUNICATING ARTERY ANEURYSM. IT HAD A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PATIENT HAD AN ANTERIOR COMMUNICATING ARTERY ANEURYSM AND UNDERWENT STENT-ASSISTED COIL EMBOLIZATION. A DUA L-MICROCATHETER TECHNIQUE WAS USED. AFTER BOTH MICROCATHETERS WERE POSITIONED, THE COIL WAS FIRST DELIVERED THROUGH ONE ECHELON-10 MICROCATHETER. DURING COIL DELIVERY, A SEVERE KICKBACK EFFECT OCCURRED, AND THE MICROCATHETER WAS WITHDRAWN. AFTER COMPLETE DEPLOYMENT OF THE STENT, THE COIL WAS DELIVERED THROUGH THE SECOND MICROCATHETER. DURING ATTEMPTED DELIVERY OF A QC-2-4-3D COIL, THE COIL COULD NOT BE ADVANCED INTO THE MICROCATHETER. DESPITE MULTIPLE ATTEMPTS, ADVANCEMENT REMAINED UNSUCCESSFUL. THE MICROCATHETER WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641932 ↗
• MalfunctionMay 26, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT DETACH AFTER USING THE DETACHER MORE THAN 3 TIMES. THEN, THE DOCTOR ATTEMPTED TO DETACHED WITH MANUAL DETACHMENT BUT THE COIL COULD NOT DETACH. THE DETACHING OF THE COIL WAS UNSUCCESSFUL. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT ARE UNKNOWN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A NEUROVASCULAR ABNORMALITIES (E.G. ARTERIOVENOUS MALFORMATIONS OR FISTULAE). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS UNKNOWN AND VESSEL TORTUOSITY WAS UNKNOWN. ANCILLARY DEVICES INCLUDE A FG11150-0615-2X (BATCH 232300140) MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277278 ↗
• MalfunctionMay 19, 2026Break; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE AXIUM COIL PACKAGE AND PREPARING IT AS USUAL, A KINK WAS OBSERVED ON THE COIL PUSH ROD DURING DELIVERY. FOR PROCEDURAL SAFETY, ANOTHER COIL WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER ANOTHER COIL WAS USED INSTEAD, DELIVERY WAS NORMAL AND THE PROCEDURE WAS SUCCESSFUL; THE MICROCATHETER HAD NO ISSUES. THERE WAS PUSHER KINK/BROKEN. A CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. THE PUSHWIRE DISTAL SEGMENT WAS DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). 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 25217835 ↗
• MalfunctionMay 14, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM OF THE C7 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY, WITH A MAX DIAMETER OF 6.8 MM AND A 4.1 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED. A TREATMENT PATHWAY WAS ESTABLISHED VIA FEMORAL ARTERY PUNCTURE. AFTER THE GUIDEWIRE ADVANCED THE MICROCATHETER INTO POSITION, AN AXIUM COIL WAS DELIVERED INTO THE MICROCATHETER AND ADVANCED INTO THE ANEURYSM. ONCE IN POSITION, THE COIL COULD NOT BE DETACHED. THE SECONDARY DETACHMENT POINT WAS MANUALLY ACTIVATED, BUT THE COIL STILL COULD NOT BE DETACHED. THE NUMBER OF ATTEMPTS MADE BY THE PHYSICIAN TO DETACH THE COIL WITH THE INSTANT DETACHER IS UNKNOWN. THE PHYSICIAN DID NOT ATTEMPT DETACHMENT USING ANOTHER INSTANT DETACHER. A MANUAL DETACHMENT ATTEMPT VIA HYPOTUBE WAS PERFORMED. THE NUMBER OF TIMES THE MANUAL DETACHMENT METHOD WAS ATTEMPTED IS UNKNOWN. THE INSTANT DETACHER WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE IT WAS LOST. NO ISSUE WITH THE INSTANT DETACHER WAS REPORTED. TO ENSURE PROCEDURAL SAFET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173304 ↗
• 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 ↗
• MalfunctionApr 27, 2026Stretched; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE AND WERE DAMAGED DURING DELIVERY IN AN ECHELON 10 MICRO CATHETER. THE PATIENT WAS UNDERGOING HEPATIC ARTERY COIL EMBOLIZATION PROCEDURE VIA FEMORAL ARTERY ACCESS. 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). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE ECHELON MICROCATHETER WAS IN PLACE AT THE TREATMENT LOCATION. THE FIRST COIL SELECTED QC-12-40-3D (LOT NUMBER 230184266). AFTER THE COIL WAS PREPARED AND HYDRATED, RESISTANCE WAS FELT WHEN ADVANCING THE COIL IN THE MIDDLE SEGMENT OF THE ECHELON MICROCATHETER AND THE MIDDLE OF THE PUSHER BECAME KINKED. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER QC-12-40-3D COIL (LOT NUMBER 230193615) WHICH WAS PREPPED AND HYDRATED. AGAIN, THERE WAS SIGNIFICANT RESISTANCE DURING DELIVERY. THE COIL STRETCHED IN THE MICROCATHETER. THE SYSTEM WAS THEM REPLACED AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009420 ↗
• MalfunctionApr 27, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE AND WERE DAMAGED DURING DELIVERY IN AN ECHELON 10 MICRO CATHETER. THE PATIENT WAS UNDERGOING HEPATIC ARTERY COIL EMBOLIZATION PROCEDURE VIA FEMORAL ARTERY ACCESS. 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). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE ECHELON MICROCATHETER WAS IN PLACE AT THE TREATMENT LOCATION. THE FIRST COIL SELECTED QC-12-40-3D (LOT NUMBER 230184266). AFTER THE COIL WAS PREPARED AND HYDRATED, RESISTANCE WAS FELT WHEN ADVANCING THE COIL IN THE MIDDLE SEGMENT OF THE ECHELON MICROCATHETER AND THE MIDDLE OF THE PUSHER BECAME KINKED. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER QC-12-40-3D COIL (LOT NUMBER 230193615) WHICH WAS PREPPED AND HYDRATED. AGAIN, THERE WAS SIGNIFICANT RESISTANCE DURING DELIVERY. THE COIL STRETCHED IN THE MICROCATHETER. THE SYSTEM WAS THEM REPLACED AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009413 ↗
• MalfunctionApr 20, 2026Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, RIGHT-SIDED C7 ANEURYSM WITH A MAX DIAMETER OF 4.8 MM AND A 3.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING INTRACRANIAL ANEURYSM EMBOLIZATION, WHEN FILLING THE SECOND COIL, PREMATURE DETACHMENT OF THE COIL WAS OBSERVED UNDER IMAGING. THE COIL WAS REMOVED, REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED. THERE WAS REPORT THAT THE QC-3-4-3D WAS STRETCHED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE IMPLANT COIL WAS RETURNED FROM THE PATIENT. IT WAS REMOVED EXTRACORPOREALLY USING A GOOSENECK SNARE. 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 ATTEMPT TO DETACH THE COIL. TH PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927667 ↗

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