Axium Prime Detachable Coil System APB-1-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000313630), received between May 9, 2023 and Jun 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STUCK IN THE SHEATH. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). HOWEVER, WHEN THE DOCTOR ATTEMPTED TO REMOVE THE COIL FROM THE PROTECTIVE SHEATH, IT COULD NOT BE PUSHED OUT SO THE COIL COULD NOT BE USED. NO PATIENT INFORMATION WAS REPORTED. ANCILLARY DEVICES: NAVIEN CATHETER, ECHELON MICROCATHETER, AVIGO GUIDEWIRE ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. NO DAMAGE WAS OBSERVED TO THE APB-1-4-3D-ES DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL, AND THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666296 ↗
• MalfunctionApr 29, 2026Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON APRIL 27, A PATIENT WITH AN INTRACRANIAL C7 ANEURYSM WAS TREATED. AFTER COMPLETION OF DIAGNOSTIC ANGIOGRAPHY, ACCESS WAS ESTABLISHED USING A 6F INTRACRANIAL SUPPORT CATHETER, A 27 MICROCATHETER, AND AN ECHELON MICROCATHETER. AFTER THE 27 STENT CATHETER AND THE ECHELON MICROCATHETER WERE POSITIONED, A PED-375-20 WAS ADVANCED AND PARTIALLY DEPLOYED. A PRIME 3D 1-4 COIL WAS THEN PLACED INTO THE ECHELON MICROCATHETER, BUT AFTER THE COIL WAS DELIVERED INTO THE MICROCATHETER, IT COULD NOT COME OUT. SUBSEQUENTLY, A PRIME 3D 1-2 COIL WAS OPENED INSTEAD, WHICH ALSO COULD NOT BE ADVANCED INTO THE ECHELON MICROCATHETER. SUSPECTING AN ISSUE WITH THE MICROCATHETER, IT WAS REPLACED WITH ANOTHER ECHELON MICROCATHETER (105-5091-150). THE PRIME 3D 1-4 COIL WAS THEN SUCCESSFULLY ADVANCED THROUGH THE MICROCATHETER AND USED TO EMBOLIZE THE ANEURYSM; HOWEVER, DETACHMENT WAS UNSUCCESSFUL AFTER TWO ATTEMPTS. THE COIL WAS SUBSEQUENTLY REPLACED WITH A PRIME 3D 1-2, WHICH ALSO COULD NOT BE DETACHED. AFTER REPLACING IT AGAIN WITH ANOTHER PRIME 3D 1-2 COIL, EMBOLIZATION AND DETACHMENT WERE SUCCESSFUL. THE FLOW-DIVERTING STENT WAS DEPLOYED AT THE SAME TIME, THE PROCEDURE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034702 ↗
• MalfunctionMar 31, 2026Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A DETACHABLE COIL APB-3-8-3D-ES WAS DELIVERED USING AN ECHELON 10 MICROCATHETER. THE COIL DID NOT FORM A HOOP WELL WITHIN THE ANEURYSM; THE OPERATOR NOTED THAT THE MIDDLE SEGMENT WAS STRAIGHT AND UNSHAPED, SO IT WAS WITHDRAWN AND DISCARDED. THE OPERATOR THEN REPLACED THE FIRST COIL WITH AN APB-3-6-3D-ES COIL FOR EMBOLIZATION. AFTER COMPLETE FILLING, THE COIL WAS KINKED AND WITHDRAWN, AND DETACHMENT WAS ATTEMPTED WITH THE DETACHMENT WIRE, BUT THE COIL WAS NOT DETACHED. THE ENTIRE COIL WAS RETRIEVED, AND THE SAME MODEL COIL WAS USED TO CONTINUE THE PROCEDURE. AS THE FINAL COIL FOR EMBOLIZATION, UNDER CONTINUOUS DRIP INFUSION, PUSHING THE COIL THROUGH THE ECHELON 10 MICROCATHETER WAS VERY DIFFICULT AND RESISTANT. THE CATHETER WAS WITHDRAWN, AND UPON REMOVAL, IT WAS FOUND THAT THE COIL HAD ALREADY BEEN STRETCHED, WAS NOT IMPLANTED, AND THE TREATMENT WAS CONCLUDED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT MIDDLE CEREBRAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747467 ↗
• MalfunctionJan 13, 2026Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED. REGARDING COIL QC-2-6-3D (LOT: 230139130), THE INTRODUCER SHEATH WAS HELD VERTICALLY DURING PREPARATION WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. IT COULD NOT BE DETERMINED WHETHER THERE WAS ANY KINK OR DAMAGE TO THE COIL AFTER REMOVAL, AND THE CAUSE OF THE COIL RESISTANCE OR BEING STUCK IN THE SHEATH WAS NOT DETERMINED. FOR COIL APB-1-4-3D-ES (LOT: 230592904), IT COULD NOT BE DETERMINED IF THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY OR IF THERE WAS ANY KINK OR DAMAGE OBSERVED ON THE PUSHWIRE. THE CAUSE OF THE COIL STRETCH AND BREAK WAS NOT DETERMINED. IN GENERAL, IT WAS NOTED THAT THE CATHETER USED WAS NOT A MEDTRONIC PRODUCT. IT COULD NOT BE DETERMINED IF THERE WAS ANY DAMAGE TO THE CATHETER AFTER REMOVAL. THE PROCEDURE WAS COMPLETED BY REPLACING THE ENTIRE SYSTEM, SUCCESSFULLY POSITIONING THE MICROCATHETER, AND USING A NEW COIL FOR EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056149 ↗
• MalfunctionNov 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME BARE 3D COIL MET RESISTANCE AND WAS STUCK IN THE MIDDLE OF A MICROCATHETER. THE SPRING COIL WAS REPLACED WITH A NEW COIL OF THE SAME MODEL AND SIZE TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE TO THE MICROCATHETER OR COIL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT MIDDLE CEREBRAL ARTERY M1 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3.2 MM AND A 1.4 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). ADDITIONAL INFORMATION RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE CATHETER WAS AN ECHELON 10 MICROCATHETER MODEL: 105-5091-150, LOT NUMBER WAS UNKNOWN. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. ADDITIONAL INFORMATION RECEIVED REPORTED THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH OTHER COILS AFTER THE COMPLAINT COIL WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483222 ↗
• MalfunctionAug 14, 2025Stretched; Stretched

  IT WAS REPORTED THAT THE AXIUM PRIME SPRING COIL WAS FOUND TO BE STRETCHED IN THE INTRODUCER SHEATH DURING PRODUCT FLUSHING. THE PRODUCT WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS INSPECTED PRIOR TO FLUSHING AND DID NOT BECOME STRETCHED DURING THE FLUSHING PROCESS. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810255 ↗
• MalfunctionJun 5, 2024Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STRETCHED OR PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4.1MM AND THE NECK DIAMETER WAS 2.9MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER WAS FLUSHED CONTINUOUSLY PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS INSPECTED AND TESTED PRIOR TO USE WITH NO ISSUE REPORTED.  THERE WAS RESISTANCE DURING DELIVERY OF THE AXIUM COIL IN THE DISTAL END OF THE ECHELON 10 MICROCATHETER. IT WAS NOTED THAT THE CATHETER TIP WAS FOUND TO HAVE FALLEN OFF DURING DELIVERY OF THE COIL AND LEAK WAS OBSERVED. ADDITIONALLY, THE COIL STRETCHED AND DETACHED PREMATURELY. DESPITE REPORT THAT THE CATHETER HAD RESISTANCE, THE SITE NOTED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER AND THE PUSHER WAS NOT BENT OR BROKEN. ALL SYSTEM PARTS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470519 ↗
• MalfunctionAug 24, 2023Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612342 ↗
• MalfunctionMay 9, 2023Stretched; Migration; Stretched; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED AFTER THE SPRING COIL WAS STRETCHED, THE SPRING COIL WAS WITHDRAWN, AND THE FILLING WAS NOT CONTINUED. AFTER THE TWO COILS HAD STRETCHED, THEY WERE REMOVED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE PATIENT HAS NOT AND WILL NOT RECEIVE ANY MEDICAL OR SURGICAL INTERVENTION ASA RESULT OF THE MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895046 ↗