Axium Prime Detachable Coil System APB-4-12-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536038240), received between Jan 27, 2022 and Sep 23, 2026 — classified as 1 death, 12 malfunctions.

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

• MalfunctionSep 23, 2026Detachment of Device or Device Component

  Medtronic received a report that the doctor pushed the Axium coil into Headway microcatheter, and then the coil auto detach in microcatheter. It was unknown if the reported device and any accessory devices were prepared as indicated in the instructions for use (IFU). No patient symptoms or complications were associated with this event.    Ancillary devices include a Chikai10 Guidewire.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868423 ↗
• MalfunctionMay 21, 2026Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF AXIUM PREMATURE DETACHMENT, STRETCHING, AND RESISTANCE WITH AN ECHELON MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INTERNAL CAROTID ARTERY C6 SEGMENT ANEURYSM. THE ANEURYSM IS A REGULAR SACCULAR, UNRUPTURED SIDEWALL NARROW-NECK ANEURYSM, WITH A MAX DIAMETER OF 4.6 MM AND A 3.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT AFTER THE ECHELON WAS POSITIONED, THE OPERATOR BEGAN COIL PLACEMENT. WHEN PLACING THE 4-12SS AXIUM COIL, PROXIMAL ADVANCEMENT WAS RELATIVELY SMOOTH; WHEN REACHING THE TIP END OF THE ECHELON, SLIGHT RESISTANCE WAS FELT. DURING ANEURYSM EMBOLIZATION, THE COIL WAS FOUND TO BE DETACHED. THE COIL WAS THEN REMOVED, AND COIL STRETCHING COULD BE OBSERVED OUTSIDE THE BODY. SUBSEQUENT COILS WERE DEPLOYED SMOOTHLY, AND THE PATIENT WAS UNAFFECTED. THE ECHELON USED DURING THE PROCEDURE HAD NO ISSUES. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241991 ↗
• MalfunctionFeb 5, 2026Break; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL BREAK AND RESISTANCE WITH THE ECHELON MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.5 MM AND A 3.19 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL BROKE OFF INSIDE THE MICROCATHETER AND COULD NOT BE PUSHED. THE PHYSICIAN THEN CHANGED THE COIL TO ANOTHER APB-4-10-3D-SS COIL AND CONTINUED THE PROCEDURE. THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE COIL WAS DAMAGED AT THE PUSHWIRE MIDDLE SEGMENT. THE CATHETER WAS NOT DAMAGED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A ECHELON 10 MICROCATHETER AND AN AVIGO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271855 ↗
• MalfunctionSep 17, 2025Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STUCK INSIDE THE MICROCATHETER. WHEN PULLED BACK, IT WAS ALREADY BROKEN. BACKUP PRODUCT WAS USED TO CONTINUE THE PROCEDURE. THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THERE WAS NO DAMAGE TO THE CATHETER OR COIL. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT IS ALIVE WITH NO INJURY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF NEUROVASCULAR ABNORMALITIES. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073385 ↗
• MalfunctionMay 22, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL RELEASE MECHANISMS ARE NOT BEING REPORTED FOR THE STUDY. THERE IS NO ISSUE WITH THE PROGRESS OF THE DEVICES THROUGH THE SYSTEM. NO DAMAGE IS OBSERVED IN THE PUSHER. THE ERROR OCCURRED WITH TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072203 ↗
• MalfunctionJun 7, 2024Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT CHANGE WHEN THE DELIVERY ROD WAS PUSHED FORWARD AND WITHDRAWN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT MIDDLE CEREBRAL ARTERY WITH A MAX DI AMETER OF 4.2 MM AND A 2.3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT MIDDLE CEREBRAL ARTERY ANEURYSM, BLOOD VESSELS WERE MEASURED AFTER ANGIOGRAPHY, THE ANEURYSM SIZE WAS 4.2MM X 3.6MM, 6F-90 LONG SHEATH + 6F105NAVIEN WAS USED FOR ACCESS, SYNCHRO14 GUIDE WIRE 105-5091-150 MICROCATHETER PASSED THROUGH THE GUIDE WIRE TO THE M3 SEGMENT, THE GUIDE WIRE WAS WITHDRAWN, AND ANOTHER 145-5091-150 WAS USED AND PUSHED TO THE ANEURYSM, AND THEN APB-4-12-3D-SS WAS FILLED AFTER HYDROPHILIC. AFTER FILLING MORE THAN HALF, FORMING A HOOP WAS NOT IDEAL, SO IT WAS WITHDRAWN AND ADJUSTED AND RE-FILLED. WHEN RE-FILLING HALF OF THE ADJUSTMENT, IT WAS FOUND THAT THE SPRING COIL DID NOT CHANGE WHEN THE DELIVERY ROD WAS PUSHED FORWARD AND WITHDRAWN. AFTER IT WAS WITHDRAWN FROM THE BODY TOGETHER WITH THE MICROCATHETER, IT WAS FOUND THAT THE STRETCHED WIRE OF THE COIL WAS STRETCHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484495 ↗
• MalfunctionFeb 28, 2024Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE TO PACKAGING. THE PROXIMAL END OF THE¿PUSHWIRE¿WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE¿PACKAGE WAS¿OPENED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND, THE COIL WAS NOT USED. THERE WERE NO DETACHMENT ATTEMPTS. THE PUSHWIRE WAS BENT AND THE DETACHMENT ZONE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800612 ↗
• MalfunctionOct 20, 2023Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THE DETAILS WERE NOT CLEAR ON WHETHER OR NOT PREMATURE DETACHMENT OCCURRED OR COIL SEPARATION/BREAK. THE COIL BODY AND PUSH ROD WERE BOTH IN THE MICROCATHETER. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE CATHETER MODEL AND LOT NUMBER WERE 145-5091-150/B539016.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974993 ↗
• MalfunctionOct 19, 2023Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS USED AS THE INITIAL COIL FOR ANEURYSM EMBOLIZATION. THE SURGEON FOUND THAT THE FORMED HOOP WAS NOT IDEAL. WHEN THE SURGEON WANTED TO RETRACT AND ADJUST IT, THE SURGEON FOUND THAT THE AXIUM COIL HAD DETACHED ITSELF AND STRETCHED. USED THE SOLITAIRE AB STENT TO PULL OUT THE AXIUM COIL, REPLACED IT WITH ANOTHER AXIUM COIL OF THE SAME MODEL, AND SUCCESSFULLY COMPLETED THE OPERATION. AFTER THE OPERATION, THE PRODUCT IN QUESTION WAS COLLECTED AND FOUND THAT THERE WAS INDEED NO TRACE OF DETACHMENT AT THE END OF THE AXIUM COIL PUSH ROD. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION NEEDED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY AND THE PHYSICIAN DID NOT REPOSITION THE AXIUM COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE AND CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE

  Patient problems: Foreign Body In Patient

  MAUDE report 17964551 ↗
• MalfunctionJan 11, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING AND AXIUM COIL STUCK IN SHEATH/RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT SIDE OF INTERNAL CAROTID ARTERY OPH THALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 4.4 MM AND A 2.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE SPRING COIL WAS NORMAL DURING THE IN VITRO PREPARATION. WHEN IT WAS ENTERING THE Y-VALVE FROM THE INTRODUCER SHEATH. IT WAS REPORTED THERE WAS COIL RESISTANCE/ THE COIL GOT STUCK IN THE SHEATH. 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. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16140212 ↗
• 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 14633075 ↗
• MalfunctionApr 28, 2022Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DID NOT DETACH AND IT WAS SUSPECTED THE COIL STRETCHED. THE PATIENT WAS BEING TREATED FOR A PULMONARY ARTERY MALFORMATION. THE PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL.  WHEN THE OPERATOR PERFORMED PULMONARY ARTERIAL HYPERTENSION SURGERY FOR THE PATIENT, AND WHEN USING OUR PRIME FOR FILLING, THE OPERATOR USED THE STANDBY DETACHMENT METHOD TO DETACH, AND THE DETACHMENT WAS INCOMPLETE. AFTER THE DETACHMENT, A PIECE OF WIREWAS PULLED OUT OF THE TUMOR CAVITY WITH A PIECE OF MICROCATHETER, AND THE SURGEON SUSPECTED THAT THE COIL WAS STRETCHED. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE DAMAGE WAS LOCATED AT THE PUSHWIRE PROXIMAL SEGMENT. THE PHYSICIAN DID NOTA ATTEMPT TO DETACH THE COIL WITH AN INSTANT DETACHER. ONE MANUAL ATTEMPT WAS MADE TO DETACH WITH THE HYPOTUBE. THERE WAS NO ISSUES WITH THE INSTANT DETACHER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14244079 ↗
• MalfunctionJan 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS DELIVERED BEFORE IT ARRIVED AT THE ANEURISM WITH NO DETACHMENT DEVICE. 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 REPOSITION THE COIL AND DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ACM ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 1.7MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367629 ↗

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