Axium Prime Detachable Coil System APB-2.5-6-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000313715), received between Oct 31, 2022 and May 11, 2026 — classified as 1 injury, 12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THREE AXIUM PRIME BARE COILS OF DIFFERENT MODELS AND LOTS HAD RESISTANCE/WERE STUCK IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED OUT. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE COIL RESISTANCE AND THE COIL BECOMING STUCK IN THE SHEATH WAS SUSPECTED TO BE RELATED TO THE PLASTIC COIL INTRODUCER SHEATH. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED THROUGHOUT THE PROCEDURE AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD HORIZONTALLY FLAT ON THE TABLE WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. PRIOR TO THE ATTEMPT TO PLACE ADDITIONAL COILS, THREE COILS HAD ALREADY BEEN SUCCESSFULLY DEPLOYED WITHIN THE ANEURYSM. THE PROCEDURE WAS SUBSEQUENTLY CONCLUDED, AS THE ANEURYSM OCCLUDED SPONTANEOUSLY AFTER SEVERAL MINUTES. IT WAS NOTED THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE ISSUE OCCURRED OUTSIDE THE PATIENTS BODY SO IT WAS CONSIDERED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25139057 ↗
• MalfunctionMar 10, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2025, THE PHYSICIAN PERFORMED A SURGICAL PROCEDURE TO TREAT A RIGHT INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING SEGMENT ANEURYSM. USING AN ECHELON 10 MICROCATHETER, THE FIRST COIL WAS DEPLOYED TO FORM A HOOP, AND SUBSEQUENT COILS WERE THEN INSERTED. WHEN USING THE APB-2.5-6-3D-ES COIL (LOT NUMBER 229582681), WHEN PREPARING FOR HYDRATION, THE COIL DID NOT ADVANCE SMOOTHLY WHEN BEING PUSHED THROUGH THE INTRODUCER SHEATH. THE SURGEON SUSPECTED A PROBLEM WITH THE COIL AND REPLACED IT WITH A DIFFERENT MODEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND A PRODUCT COMPLAINT WAS FILED REGARDING THE COIL. 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, RUPTURED RIGHT INTERNAL CAROTID ARTERY ANEURYSM IN THE POSTERIOR COMMUNICATING SEGMENT WITH A MAX DIAMETER OF 4MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563020 ↗
• MalfunctionFeb 12, 2026Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE COIL WAS ADVANCED INTO THE ANEURYSM BY PUSHING IT WITH THE COIL PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24325276 ↗
• MalfunctionJan 29, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE DELIVERY OF THE AXIUM PRIME BARE 3D COIL FOR THE FINAL CLOSING LOOP, THE COIL COULD NOT BE ADVANCED INTO THE MICROCATHETER. THE COIL WAS REPLACED WITH A NEW COIL OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. RESISTANCE WAS ENCOUNTERED AT THE HUB OF THE ECHELON CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO KINK OR DAMAGE WAS OBSERVED TO EITHER THE COIL OR THE CATHETER AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210827 ↗
• MalfunctionNov 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED, BUT IT OCCURRED DURING DELIVERY AND WAS LOCALIZED TO THE MIDDLE SECTION OF THE CATHETER. THERE WAS NO RESISTANCE NOTED DURING RETRACTION, RESHEATHING, OR WITHDRAWAL. IT WAS NOT DETERMINED WHETHER THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO KINK OR DAMAGE WAS FOUND ON EITHER THE COIL OR THE CATHETER AFTER REMOVAL. INFORMATION REGARDING WHETHER THE INTRODUCER SHEATH WAS HELD VERTICALLY DURING COIL HYDRATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479778 ↗
• MalfunctionJul 21, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE SPRING COIL FAILED TO COME OUT OF THE CATHETER AND FELL INTO THE MICROCATHETER. 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 22554877 ↗
• InjuryJul 11, 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 ON REMOVING THE COIL BACK INTO THE SHEATH, THEY NOTICED THERE WAS NO COIL ATTACHED. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. PATIENT WAS CHECKED AND NO COIL WAS FOUND. THERE'S A POSSIBILITY IT COULD BE IN THE ECHELON 10 BUT OTHERWISE UNKNOWN. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. IT WAS UNKNOWN IF THE PUSHWIRE WAS BENT OR BROKEN. THERE WAS 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 PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE CASE WAS ABANDONED DUE TO REMOVAL OF MICRO CATHETER AND SAFETY CONCERNS WITH ANEURYSM. ADDITIONALLY, THE COIL ADVANCED THROUGH ECHELON 10 AND WAS BLOCKED AT SAME POINT AFTER TRYING TO INTRODUCE COIL TWICE. THERE WAS CATHETER RESISTANCE AND CATHETER OCCLUSION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOIN

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

  MAUDE report 22480372 ↗
• MalfunctionMar 19, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED EVEN WITH THE INSTANT DETACHER. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. NO PATIENT INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644100 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE PREMATURE DETACHMENT DETERMINED WAS NOT DETERMINED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS OR INJURY. THE ANEURYSM WAS RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM, 3.5*2.8. VESSEL TORTUOSITY WAS NORMAL. THE PROCEDURE WAS COMPLETED, STENT-ASSISTED COIL TO FILL. ONE WAS FILLED BEFORE AND TWO WERE FILLED AFTER THIS MALFUNCTIONED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447164 ↗
• MalfunctionMar 13, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PREMATURE DETACHMENT HAD OCCURRED. THE PATIENT DID NOT GO THROUGH ANY SYMPTOMS REGARDING DETACHMENT ISSUE. PRIOR TO COIL NON-DETACHMENT THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534008 ↗
• MalfunctionDec 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT REGARDING AN AXIUM COIL PREMATURE DETACHED IN THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT ANTERIOR COMMUNICATING ARTERY (ACOMM) WITH A MAX DIAMETER OF 3 MM AND A 1.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL PRE-DETACHED IN THE CATHETER DELIVERING THE COIL. THE COIL WAS REMOVED FROM THE PATIENT BY THE C ATHETER. 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 REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A FUBUKI 8F GUIDE CATHETER AND AN SL10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004811 ↗
• MalfunctionNov 8, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED NO SYMPTOMS. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT. THERE WAS NO PUS HWIRE¿DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751849 ↗
• MalfunctionOct 31, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE PATHWAY WAS ESTABLISHED BY THE SURGEON, THE SPRING COIL WAS DELIVERED IN THE MICROCATHETER. DURING THE DELIVERY PROCESS, IT WAS FOUND THAT THE DELIVERY ROD COULD NOT BE PUSHED FORWARD. THE COIL BODY COULD NOT BE PUSHED FORWARD, AND THE TIP OF IT COULD NOT COME OUT OF THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE DELIVERY ROD WAS WITHDRAWN AND THIS SPRING COIL SYSTEM WAS WITHDRAWN FROM THE MICROCATHETER. THE PUSHER WAS KINKED/BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING/DELIVERY. IT WAS UNKNOWN IF CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED LOCATION ON THE DEVICE WAS UNKNOWN. A NEW SPRING COIL WAS USED TO COMPLETE THE EMBOLIZATION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. 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 INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ARTERY SE GMENT ANEURYSM WITH A MAX DIAMETER OF 2.47 MM AND A 1.98 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15702790 ↗