Axium Prime Detachable Coil System APB-3-6-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000313968), received between Feb 18, 2025 and Sep 24, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Separation Failure; Detachment of Device or Device Component; Material Deformation

  Medtronic received a report of a Axium coil that had prematurely detached from non-detachment with the backup method. The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm located in the middle cerebral artery bifurcation section with a max diameter of 5mm and a 2.4mm neck diameter. It was noted the patient's blood flow was normal, and the vessel tortuosity was normal. No images are available for review. It was reported that when using the coil involved in this event, after coil deployment was completed, detachment was attempted using the backup detachment method. After breaking the backup detachment point and pulling out the detachment wire, it was found that the coil had not separated from the delivery wire. The delivery wire was repeatedly advanced and withdrawn, but the coil still could not be detached. Torque was applied, and the delivery wire was repeatedly rotated 360 degrees, but it still could not be detached. The operator then attempted to withdraw the entire coil into the microcatheter. While withdrawing it into the microcatheter, the coil detached. The operator believed that the coil detachment point was abnormal and requested factory inspect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882692 ↗
• MalfunctionFeb 5, 2026Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF AN AXIUM COIL THAT HAD ENCOUNTERED FRICTION/DIFFICULTY DURING DELIVERY, HAD PREMATURE DETACHMENT, AND SEPARATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE 360 TARGET COIL 4X10 WAS INSERTED WITH NO PROBLEM. HOWEVER, WHEN TRYING TO INSERT THE AXIUM HELIX 3X6 MICRO CATHETER TO REPOSITION THE ANEURYSM, SO THE COIL HAD MOVED/RETURNED TO THE SHEATH. WHEN TRYING TO INSERT THE COIL BACK TO THE MICROCATHETER THE COIL DETACH BY ITSELF INSIDE THE SHEATH. IT WAS NOTED THAT FOLLOWING OCCURRED COIL SEPARATION/BREAK/PREMATURE DETACHMENT AND THERE WAS FRICTION/DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL ONLY ONCE. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24271803 ↗
• MalfunctionJan 20, 2026Difficult or Delayed Positioning; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE DETACHMENT WAS PERFORMED MANUALLY AND AN INSTANT DETACHER WAS NOT USED. THE CAUSE OF THE COIL NON-DETACHMENT, THE DIFFICULTY IN PLACEMENT, AND THE COIL JUMPING DURING DEPLOYMENT WERE NOT DETERMINED. THERE WERE TWO ATTEMPTS MADE TO DETACH THE COIL MANUALLY. NO PRIOR PROBLEMS WERE OBSERVED BEFORE THE NON-DETACHMENT EVENT, AND NO VISIBLE DAMAGE TO THE PUSHWIRE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119162 ↗
• MalfunctionDec 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AXIUM COIL EXPERIENCED RESISTANCE IN THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6MM. IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE SURGEON DELIVERED THE AXIUM COIL AFTER THE ECHELON MICROCATHETER WAS IN PLACE. DESPITE REPEATED ATTEMPTS, THE COIL TIP COULD NOT REACH THE PROXIMAL END OF THE MICROCATHETER. THE SURGEON REPLACED THE AXIUM COIL WITH ANOTHER AXIUM COIL AND TRIED AGAIN, BUT AGAIN, IT COULD NOT REACH THE PROXIMAL END OF THE MICROCATHETER. AFTER REPLACING THE MICROCATHETER AND BOTH COILS, THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER AND AN ADDITIONAL AXIUM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794688 ↗
• MalfunctionAug 11, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT WHEN THE INNER PACKAGE WAS OPENED AND THE AXIUM COIL WAS TAKEN OUT, IT WAS FOUND THAT THE COIL PUSHER WIRE WAS KINKED/BROKEN AT THE PROXIMAL END SO THE DEVICE COULD NOT BE USED. IT WAS NOTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO FRICTION DURING COIL TESTING OR DELIVERY. AS THE ISSUE WAS OBSERVED PRIOR TO USE IN THE PATIENT'S BODY, IT IS CONSIDERED THAT THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO EVIDENCE OF DAMAGE OR TAMPERING TO DEVICE PACKAGING. THE DAMAGE WAS NOT NOTICED UPON OPENING THE PACKAGED. NO PREP WAS PERFORMED PRIOR TO DAMAGE BEING SEEN. THERE WAS NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. REPLACED WITH A NEW SPRING COIL AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777927 ↗
• MalfunctionFeb 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT CTA AT AN EXTERNAL HOSPITAL SHOWED AN IRREGULAR ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. COMPREHENSIVE ASSESSMENT AND CONSIDERATION SHOWED THAT THE RISK OF RUPTURE WAS RELATIVELY HIGH, AND THE PATIENT HAD SYMPTOMS OF OCULOMOTOR NERVE PALSY, AND HAD TREATMENT INDICATIONS, SO FEMORAL ARTERY PUNCTURE AND NEUROINTERVENTIONAL MINIMALLY INVASIVE TREATMENT OF INTRACRANIAL ANEURYSMS WERE PERFORMED: LVIS STENT-ASSISTED SPRING COIL EMBOLIZATION OF THE ANEURYSM. DURING FEMORAL ARTERY PUNCTURE, THE 6F 90CM KINDLY LONG SHEATH SUCCESSFULLY REACHED THE POSTERIOR BEND OF THE CAVERNOUS SINUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY WITH THE COAXIAL ASSISTANCE OF A 0.035-INCH LOACH GUIDEWIRE AND A MULTIFUNCTIONAL ANGIOGRAPHY TUBE. THE SYCHRO 0.014-INCH GUIDEWIRE ASSISTED HEADWAY TO SUCCESSFULLY BE PLACED IN THE DISTAL END OF THE ANEURYSM OF THE PARENT ARTERY, AND THEN CONTINUED TO ASSIST ECHELON TO BE PLACED IN THE ANEURYSM CAVITY. EVERYTHING WENT WELL AT THIS TIME. THE 3D MEASUREMENT DATA SHOWED THAT THE ANEURYSM WAS ABOUT 3MM, THE FIRST APB-3-6-HELIX WAS SELECTED. HOWEVER, DURING DELIVERY, IT WAS CLEARLY FELT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403938 ↗