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

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000313623), received between May 20, 2024 and Aug 12, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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.

• MalfunctionAug 12, 2026Separation Failure; Physical Resistance/Sticking

  Medtronic received a report that Axium coils encountered resistance and non-detachment. The patient was undergoing aneurysm embolization surgery for treatment of a saccular, unruptured aneurysm located on the ophthalmic artery with a max diameter of 5mm and a 2.7mm neck diameter. The access vessel was the femoral artery with a 6mm vessel diameter. It was noted the patient's blood flow was normal and vessel tortuosity was moderate. It was reported that during the aneurysm embolization procedure, significant resistance occurred during coil delivery at the distal section of the Echelon catheter. The QC-2-6-3D  coil could not be pushed out of the protective sheath. Both the coil and microcatheter were removed and replaced. Additionally, when the APB-1-3-3D-ES S coil was delivered, it could not be detached after reaching the target position. The physician attempted to detach with the instant detacher 1. The also attempted 1 time with the second instant detacher. A manual attempt via hypo tube was attempted 2 times. The coil was withdrawn and replaced.  The catheter was flushed and all devices were prepared as indicated in the IFU. No patient complications were associated with this event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222684 ↗
• MalfunctionJun 29, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF AXIUM COILS THAT COULD NOT ADVANCE THROUGH A MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY C7 SEGMENT WITH A MAX DIAMETER OF 2.5MM AND A 0.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE MICROCATHETER MALFUNCTIONED, RESULTING IN INABILITY TO ADVANCE SUBSEQUENT COILS. AFTER REPLACING THE MICROC ATHETER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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. ADDITIONAL INFORMATION WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE REPORTED MICROCATHETER MALFUNCTION WERE IDENTIFIED. THE LOCATION OF ANY RESISTANCE WITHIN THE CATHETER (HUB, PROXIMAL, MIDDLE, OR DISTAL) COULD NOT BE DETERMINED. THE COIL EXITED THE INTRODUCER SHEATH SMOOTHLY, AND A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED PER IFU. IT IS UNKNOWN WHETHER ANY KINK OR DAMAGE WAS OBSERVED TO THE COIL OR THE CATHETER AFTER REMOVAL. THE CATHETER USED, I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25660848 ↗
• MalfunctionMay 1, 2026Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 3.89 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING COIL EMBOLIZATION THERAPY, THE AXIUM COIL DETACHED PREMATURELY DURING DELIVERY. THE PUSHWIRE WAS NOT BENT OR BROKEN. IT IS UNKNOWN WHETHER THERE WAS ANY FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, DID NOT ATTEMPT TO DETACH THE COIL, AND DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. ANOTHER COIL WAS USED INSTEAD, BUT THE SECOND AXIUM COIL ENCOUNTERED SIGNIFICANT RESISTANCE DURING DELIVERY, AND THE COIL COULD NOT PASS THROUGH THE MICROCATHETER. ANOTHER COIL WAS USED INSTEAD. THE COILS WERE REMOVED FROM THE PATIENT WITH THE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056054 ↗
• MalfunctionApr 24, 2026Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED RESISTANCE THE HUB OF AN ECHELON CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED BASILAR TOP ANEURYSM WITH A MAX DIAMETER OF 4.6MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE BASILAR ARTERY WHICH HAD A DIAMETER OF 3.4MM. IT WAS REPORTED THAT A MICROCATHETER PARKED AND STARTED COILING. WHEN THE PHYSICIAN TOOK THE 1.5MM COIL IT WAS NOT GOING THROUGH THE MICROCATHETER. THE COIL GOT STUCK AT THE HUB. THE PHYSICIAN TOOK ANOTHER COIL, AND THE SAME SITUATION OCCURRED. AFTER THEY CHANGED THE COIL, THE SAME SITUATION HAPPENED ONCE MORE. THEY CHANGED THE MICROCATHETER (PHENOM 17) AND DEPLOYED ANOTHER COIL AND COMPLETED THE CASE. THERE WAS COIL RESISTANCE AT THE CATHETER HUB. THE IMPLANT COIL PUSHED SMOOTHLY OUT OF THE INTRODUCER SHEATH. THERE WAS NO DAMAGE TO THE CATHETER OR THE COIL DURING THIS EVENT. THERE WAS ALSO CATHETER OCCLUSION WHICH OCCURRED AT THE HUB WHERE THE COILS WERE GETTING STUCK. THE CATHETER WAS FLUSHED AND ALL DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987049 ↗
• MalfunctionMar 30, 2026Break; Material Deformation; Packaging Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL PUSH WIRE BROKE AT THE PROXIMAL SEGMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 4.0 MM AND A 2.0 MM NECK DIAMETER LOCATED ON THE C6 LEFT INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION SURGERY, THE MICROCATHETER WAS INSERTED INTO THE INTERMEDIATE CATHETER AND ADVANCED TO THE LESION SITE. UPON OPENING THE APB-1-3-3D-EX, IT WAS FOUND THAT THE PUSHER ROD HAD A BREAK AT THE END. THE DEVICE WAS THEN REPLACED WITH APB-1-1-HX-EX TO COMPLETE THE SURGERY. THERE WAS FRICTION AND DIFFICULTY DURING TESTING AND DELIVERY. THE PUSH WIRE WAS KINKED AND BROKEN IN THE PROXIMAL SEGMENT OF THE DEVICE. DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A NAVIEN GUIDE CATHETER. 2026-JAN-18 E1 (REP, HCP, FOR): ADDITIONAL INFORMATION RECEIVED. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO ISSUES T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722911 ↗
• MalfunctionMar 10, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL COULD NOT BE DETACHED, SO ANOTHER ONE WAS REPLACED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED INTRACRANIAL ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 1.3MM 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 24557364 ↗
• MalfunctionNov 12, 2025Display or Visual Feedback Problem; Stretched; Unintended Movement; Migration; Display or Visual Feedback Problem; Stretched; Unintended Movement; Migration

  ADDITIONAL INFORMATION WAS RECEIVED. NO ACTIONS OR INTERVENTIONS WERE TAKEN TO RESOLVE THE COIL MIGRATION INTO THE PARENT VESSEL POST DEPLOYMENT. THE PROCEDURE WAS COMPLETED BY DIRECTLY WITHDRAWING THE MICROCATHETER, AND THE COIL WAS NOT REPLACED WITH A NEW MEDTRONIC PRODUCT. THE CAUSE OF COIL STRETCH AND POOR VISUALIZATION WAS CONFIRMED THROUGH IMAGING, AND NO ISSUES WERE IDENTIFIED THAT RESULTED IN THE OBSERVED DAMAGE. THE PATIENT DID NOT RECEIVE, AND WILL NOT REQUIRE, ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE COIL MIGRATION. NO ANTIPLATELET REGIMEN WAS ADMINISTERED BEFORE OR AFTER THE PROCEDURE. ANCILLARY DEVICES INCLUDE A ECHELON CATHETER 145-5091-150, LOT NUMBER: 0231121180).

  Patient problems: Foreign Body In Patient

  MAUDE report 23535754 ↗
• MalfunctionJan 13, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE IN THE ECHELON 10 MICROCATHETER AND THE CATHETER WAS DAMAGED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA). THE ANEURYSM MAX DIAMETER WAS 3MM AND A NECK DIAMETER OF 1MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AN AXIUM PRIME COIL COULD NOT BE ADVANCED THROUGH THE DISTAL ECHELON MICROCATHETER. THE COIL WAS REPLACED WITH ANOTHER AXIUM COIL BUT THE SAME ISSUE OCCURRED SO THE SYSTEM WAS REMOVED. THE CATHETER WAS OBSERVED TO BE DAMAGED AT THE DISTAL END. NEITHER COIL WAS DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO DETACHMENT ATTEMPTS WERE MADE. THE COIL ACCIDENTALLY BROKE DURING PROCEDURE. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE. IT WAS UNKNOWN IF THE COIL PREMATURELY DETACH IN THE CATHETER. THE PATIENT WAS BEING FOLLOWED UP WITH CLOSELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145970 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN AXIUM COIL PREMATURELY DETACHED AND AN AXIUM COIL WAS MISSING. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 6.1 MM AND NECK DIAMETER 3.3 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. WHEN THE AXIUM COIL APB-1-3-3D-ES LOT 227937270 WAS DELIVERED IT AUTOMATICALLY DETACHED IN THE CATHETER. THE ENTIRE MICROCATHETER COIL WAS WITHDRAWN. WHEN AXIUM COIL APB-1-3-3D-ES LOT 227969644 WAS BEING PUSHED OUT OF THE PROTECTIVE SHEATH, THERE WAS NO COIL. THERE WERE NO SURGICAL OR MEDICINAL INTERVENTIONS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352965 ↗