AxiumTM APB-6-15-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536008274), received between Feb 5, 2019 and Dec 3, 2025 — classified as 1 death, 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Therapy Delivered to Incorrect Body Area; Material Deformation; Unintended Movement; Migration; Therapy Delivered to Incorrect Body Area; Material Deformation; Unintended Movement; Migration

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE COIL MIGRATION INTO THE PARENT VESSEL WAS ATTRIBUTED TO THE NECK SHAPE OF THE RELEVANT ANEURYSM. THE CAUSES OF BOTH THE COIL UNRAVELING WITHIN THE MICROCATHETER AND THE PUSHER EXTENSION DAMAGE REMAIN UNKNOWN. IT IS CONSIDERED THAT NO ISSUES RESULTED IN THE DAMAGE THAT WAS FOUND. THE PATIENT HAS NOT RECEIVED, AND WILL NOT RECEIVE, ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE COIL MIGRATION. THERE WERE NO CHANGES TO THE ANTIPLATELET REGIMEN ADMINISTERED TO THE PATIENT BEFORE OR AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708488 ↗
• MalfunctionApr 2, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STUCK AT THE HUB OF THE ECHELON 14 MICROCATHETER AND WAS DAMAGED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT CAROTID ARTERY UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). WHEN TRYING TO INTRODUCE THE COIL, IT PUSHED OUT SMOOTHLY FROM THE INTRODUCER SHEATH BUT COULD NOT PASS THROUGH THE ECHELON 14 MICRO CATHETER HUB. THE COIL BECAME STUCK AND WAS DAMAGED. THE CATHETER WAS NOT DAMAGED. THERE WERE NO PATIENT SYMPTOMS, COMPLICATIONS, OR NEED FOR MEDICAL OR SURGICAL INTERVENTION, AND THE EVENT DID NOT LEAD TO EXTENDED HOSPITALIZATION. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753044 ↗
• MalfunctionNov 10, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT 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 20649380 ↗
• MalfunctionApr 9, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL FAILED TO DETACH. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED ICPC ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 7 MM, NECK DIAMETER 3 MM. THE PATIENT¿S VESSEL TORTUOSITY AND BLOOD FLOW WAS NORMAL. THE PRODUCT FAILED TO DETACH. EVEN AFTER FORCED DETACHMENT, IT DID NOT DETACH SO THE ENTIRE MICROCATHETERWAS REMOVED. THE PHYSICIAN MADE 5 ATTEMPTS TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070394 ↗
• MalfunctionDec 28, 2023Break; Material Deformation; Break; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE AXIUM COIL "FELL OFF." THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT ANTERIOR CEREBRAL ARTERY WITH A MAX DIAMETER OF 7.3 MM AND A 5.5 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 PACKAGE, FOUND THAT THE TIP OF THE SPRING COIL FELL OFF AND COULD NOT BE USED NORMALLY. IT WAS REPORTED THE COIL WAS KINKED/DAMAGED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. TH DAMAGED/STRETCHED LOCATION WAS ON THE IMPLANT COIL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. 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 18414157 ↗
• MalfunctionApr 26, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. IT IS UNKNOWN IF THERE WAS ANY PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815644 ↗
• DeathJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING 2 AXIUM COILS THAT HAD RESISTANCE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED BASILAR TIP ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE COMPLAINT DEVICES AND ALL ACCESSORIES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS PROPERLY REMOVED FROM THE HOOP AND THERE WAS NO VISIBLE DAMAGE TO THE INTRODUCER SHEATH OR COIL HOOP. ONE COIL (MODEL: APB-6-20-3D-SS, LOT: 220885243) HAD RESISTANCE IN THE SHEATH AND WAS REPLACED. ANOTHER COIL (MODEL: APB-3.5-10-3D-ES, LOT: B173249) HAD THE INTRODUCER SHEATH PROPERLY POSITIONED IN THE HUB AND PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY BUT COULD NOT BE ADVANCED THROUGH THE HUB OF THE CATHETER. IT WAS NOTED THE DISTANCE BETWEEN THE INTRODUCER SHEATH AND THE ANGLED PORTION OF THE NON-MEDTRONIC BALLOON CATHETER WAS TOO GREAT AND THE COIL STARTED TO TAKE COILING SHAPE IN THE HUB OF THE MICROCATHETER. THE COIL WAS DAMAGED BUT THE CATHETER WAS NOT. THE COIL WAS REMOVED AND REPLACED AND OTHER COILS WERE SUCCESSFULLY DELIVERED USING THE SAME CATHETER. IT WAS NOTED

  Patient problems: Intracranial Hemorrhage

  MAUDE report 14633076 ↗
• MalfunctionNov 7, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL EXPERIENCED RESISTANCE DURING DELIVERY AND "UNRAVELED" IN THE MIDDLE PART OF THE CATHETER. THE COIL WAS DAMAGED/DETACHED EARLY. THERE WAS NO DAMAGE TO THE DELIVERY PUSHER, THE PUSHER WAS NOT RELOCATED, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE COIL WAS REPLACED, AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTIONS WERE NEEDED. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE, AND THEIR BLOOD FLOW WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759893 ↗
• MalfunctionJun 15, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT AN AXIUM COIL WAS STUCK IN THE SHEATH. IT WAS INDICATED THAT THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT IMPLANTED. THE PATIENT'S BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS HYDRATED CORRECTLY AND THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE. THERE WAS DAMAGE OBSERVED TO THE PUSHER, WAS THE REASON THE COIL DID NOT COME OUT OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12000827 ↗
• MalfunctionDec 5, 2020Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950610 ↗
• MalfunctionMay 13, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM IMPLANT COIL WAS STUCK INSIDE THE DISTAL PART OF THE MICROCATHETER. SINCE THIS WAS THE FIRST COIL USED AND IT WAS NOT ABLE TO REACH THE ANEURYSM SAC, IT WAS NECESSARY TO REMOVE THE ENTIRE SYSTEM (MICROCATHETER AND IMPLANT COIL) WITHOUT COMPLICATIONS. THE SYSTEM WAS REPOSITIONED TO CONTINUE AND COMPLETE THE TREATMENT WITHOUT FURTHER COMPLICATIONS. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A UNRUPTURED SACCULAR ANEURYSM MEASURING 6 MM X 5 MM LOCATED IN THE SILVIANA FORK. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE PATIENT¿S VASCULATURE WAS NORMAL IN TORTUOSITY. THERE ARE NO IMAGES FOR REVIEW. THERE WAS DAMAGE OBSERVED ON THE DISTAL PART OF THE MICROCATHETER AND THE DISTAL PART OF THE PUSHWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10051669 ↗
• MalfunctionDec 17, 2019Break; Stretched; Separation Failure; Break; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL FAILED TO DETACH AND THE PUSHER WIRE BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED, LEFT ACOM ANEURYSM WITH A MAX DIAMETER OF 6.8MM AND A 1.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PHYSICIAN USED THIS COIL FIRST TO TREAT THE ANEURYSM. IT DEPLOYED SUCCESSFULLY, BUT WOULD NOT DETACH WITH TWO ATTEMPTS USING THE INSTANT DETACHER. A SECOND INSTANT DETACHER WAS USED TWICE, BUT THE COIL STILL WOULD NOT DETACH. THEN, THE MANUAL ATTEMPT WAS MADE ONCE, BUT IT DID NOT DETACH. WHILE PUSHING THE COIL INSIDE THE MICROCATHETER, THE PUSHER WIRE BROKE. IT WAS INDICATED THERE WAS COIL STRETCH. SOMEHOW, THE PHYSICIAN TOOK THE BROKEN PUSHER WIRE OUT FROM THE MICROCATHETER, AND TOOK A NEW COIL TO FINISH THE CASE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9482344 ↗
• MalfunctionFeb 5, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). THE COIL DETACHED DURING REMOVAL. THE PATIENT UNDERWENT COILING TREATMENT FOR A SMALL UNRUPTURED SACCULAR RIGHT SUPERIOR CEREBELLA ARTERY ANEURYSM, MEASURING 7MMX3MM. THE VESSEL OBSERVED MINIMAL TORTUOUS. IT WAS REPORTED THAT THE PHYSICIAN WAS USING AN AXIUM PRIME 6X15 3D TO FRAME A SCA ANEURYSM WITH THE SCA ARISING FROM THE BASE OF THE ANEURYSM. WHEN HE WAS SATISFIED WITH THE POSITION OF THE COIL HE ATTEMPTED TO DETACH IT WITH AN INSTANT DETACHER. WHEN HE PULLED THE PUSHER WIRE IT COULD BE SEEN THAT THE COIL WAS STILL ATTACHED. HE REPEATED THE ATTEMPT WITH THE SAME RESULT. HE THEN BROKE THE HYPOTUBE AND PULLED THE RELEASE FILAMENT IN ORDER TO MANUALLY RELEASE THE COIL. AGAIN THE COIL CAME BACK WHEN THE PUSHER WAS PULLED BACK. HE PUSHED THE COIL SO THAT IT WAS AT LEAST 5MM OUTSIDE OF THE MICRO CATHETER BUT STILL THE COIL REMAINED ATTACHED. HE THEN MADE THE DECISION TO REMOVE THE COIL. AFTER APPROXIMATELY 2CM OF THE COIL WAS REMOVED INTO THE MICRO CATHETER IT FINALLY DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8305030 ↗

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-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
• 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