Axium Prime Detachable Coil System APB-2-4-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000313883), received between Jun 22, 2022 and Jul 16, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25847453 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE CATHETER IS AN ECHELON 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270623 ↗
• MalfunctionDec 26, 2025Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE IN THE PROXIMAL SECTION OF THE ECHELON MICROCATHETER AND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE COIL DID NOT PROGRESS IN THE MICROCATHETER AND WHEN IT WAS REMOVED FOR EVALUATION, IT WAS DAMAGED. IT ENDED UP DETACHING EARLY IN THE MICROCATHETER. THERE WAS NO ACCIDENT WHEN COUPLING TO THE Y INTRODUCER, OR REMOVING IT FROM ITS HIVE. THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE DOCTOR WAS ABLE TO REMOVE IT FROM THE MICROCATHETER AFTER PREMATURE DETACHMENT. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. AFTER THE EVENT, THE DOCTOR CHANGED THE DEFECTIVE COIL AND USED ANOTHER ONE (AXIUM PRIME ES HX 3.0X10) AND HAD NO COMPLICATIONS WITH THE PRODUCT. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896105 ↗
• MalfunctionNov 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE AND INABILITY TO RESHEATH THE COIL WAS NOT DETERMINED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535088 ↗
• MalfunctionJul 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT FOR THE LEFT INTERNAL CAROTID ARTERY C7 SEGMENT ANEURYSM, ECHELON-10 WAS SHAPED AND GUIDED INTO THE ANEURYSM CAVITY BY A GUIDEWIRE. ACCORDING TO THE DIAMETER OF THE BLOOD VESSEL AT THE ANEURYSM LOCATION, THE APB-2-4-HX-ES DETACHABLE COIL WAS SELECTED, AND THE INNER AND OUTER PACKAGING WERE INTACT AND THE COIL WAS HYDRATED. WHEN THE DETACHABLE COIL WAS DELIVERED INTO THE MICROCATHETER, THE DETACHABLE COIL COULD NOT ENTER THE MICROCATHETER SMOOTHLY. AFTER MULTIPLE ATTEMPTS, THE COIL STILL COULD NOT ENTER THE MICROCATHETER SMOOTHLY. LATER, IT WAS REPLACED WITH A QC-2-4-HELIX-CN MECHANICAL DETACHABLE COIL. AFTER REPEATED ATTEMPTS, IT STILL COULD NOT ENTER THE MICROCATHETER. IT WAS INITIALLY JUDGED THAT THERE WAS A PROBLEM WITH THE MICROCATHETER WITH LOT NUMBER: 0229237919. AFTER THE MICROCATHETER WAS REPLACED WITH ANOTHER ONE WITH LOT NUMBER: 0228177322, THE DETACHABLE COIL APB-2-4-HX-ES AND THE MECHANICAL DETACHABLE COIL QC-2-4-HELIX-CN STILL COULD NOT ENTER THE MICROCATHETER. THEN REPLACED IT WITH A MICROPORT 2*4 COIL, AND THIS TIME THE COIL COULD SUCCESSFULLY ENTER THE MICROCATHETER FOR FILLING, FOLLOWED BY THE APB-1.5-2-HX-ES AND APB-1-2-H X-ESD DET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527110 ↗
• MalfunctionJul 11, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AXIUM COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE. PATIENT'S BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL COULD NOT BE DETACHED DESPITE 3 DETACHMENT ATTEMPTS WITH THE INSTANT DETACHER (ID) AND 1 MANUAL DETACHMENT ATTEMPT WITH THE HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER WHICH WAS USED AND DISCARDED AFTER THE PROCEDURE. OTHER COILS WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES: BALLAST 90 LONG SHEATH (LOT: F241000721); HEADWAY DUO MICROCATHETER; SYNCHRO 0.014" X 200CM GUIDEWIRE; COILS: APB-3-8-3D-ES-1, MICROPLEX 10  2X4 HYPERSOFT 3D, MICROPLEX 1.5X4 HYPERSOFT HELICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480380 ↗
• MalfunctionJul 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ECHELON 10 MICROCATHETER THAT HAD RESISTANCE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT OPHTHALMIC ARTERY SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS RESISTANCE IN THE ECHELON MICROCATHETER DURING DELIVERY SO THE DEVICES WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THAT THE AXIUM COIL HAD RESISTANCE DURING DELIVERY IN THE ECHELON MICROCATHETER. A STRYKER GUIDEWIRE ALSO ENCOUNTERED RESISTANCE IN THE CATHETER. CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE OBSERVED TO THE CATHETER OR COIL AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475044 ↗
• MalfunctionFeb 11, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER REPRESENTATIVE (REP) STATING THAT THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM IN THE INTERNAL CAROTID ARTERY C4 SEGMENT. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. PRIOR TO COIL NON-DETACHMENT, NO ISSUES OCCURRED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355648 ↗
• MalfunctionFeb 10, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL FAILED TO DETACH AND HAD RESISTANCE DURING RETRIEVAL, AND ANOTHER COIL ENCOUNTERED RESISTANCE IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY SEGMENT WITH A MAX DIAMETER OF 6.84MM AND A 3.13MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS REPORTED THAT THE 45° MICROCATHETER ECHELON WAS SHAPED AND PLACED IN THE MIDDLE OF THE ANEURYSM CAVITY. ACCORDING TO THE SIZE OF THE ANEURYSM, QC-6-20-3D-CN WAS USED TO FORM A HOOP, AND THEN APB-2-6-HX-ES WAS SELECTED FOR FILLING. THE INNER AND OUTER PACKAGING WERE INTACT, THE SPRING COIL WAS HYDRATED, THE PUSH RESISTANCE WAS TOO LARGE, THE SPRING COIL COULD NOT BE PUSHED OUT OF THE SPRING COIL PROTECTIVE COVER, SO THE SPRING COIL OF THE SAME SPECIFICATION WAS REPLACED AND FILLED SMOOTHLY. ONCE AGAIN, APB-2-4-HX-ES WAS SELECTED FOR FILLING, AND THE SPRING COIL WAS FILLED SMOOTHLY. AFTER MANY ATTEMPTS, IT STILL COULD NOT BE DETACHED. READY TO REPLACE THE SPRING COIL, AND FOUND IT DIFFICULT TO RETRIEVE THE SPRING COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343217 ↗
• MalfunctionOct 17, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM EMBOLIZATION, WHEN THE COIL WAS DELIVERED TO THE MICROCATHETER IN PLACE, THE COIL WAS IN THE INTRACRANIAL ARTERY SEGMENT, WHEN THE COIL WAS NOT IN PLACE, IT WAS STUCK, THE PUSH DID NOT MOVE, AND THE RESISTANCE WAS LARGE. THE COIL WAS STUCK IN THE SHEATH. WITHDREW THE COIL AND REPLACED IT WITH SIMILAR PRODUCT, THE IMPLANTATION WAS SUCCESSFUL AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE COIL WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED C4 ANEURYSM WITH A MAX DIAMETER OF 3.5MM AND A 2.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING PREPARATION 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 17952365 ↗
• MalfunctionSep 5, 2023Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO ATTEMPT TO DETACH. IT WAS NOTED THAT THERE WAS NO TWIST IN THE WIRE WAS MADE. THE MICRO SPRING WAS REMOVED FROM THE PATIENT USING MECHANICAL THROMBECTOMY MATERIAL. THE CATHETER USED WAS THE ECHELON 10 MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH THE REMOVAL OF THE MICRO SPRING WITH THE SOLITAIRE X STENT IN THE SAME WAY AS IN MECHANICAL THROMBECTOMY. THERE WILL BE NO PROCEDURE DUE TO THE MICRO SPRING, IT WAS ALREADY RESOLVED IN THE SAME PROCEDURE. THE DOCTOR RESPONDED THAT THE ANTI-PLATELET METHOD WAS THE USUAL METHOD FOR ANEURYSM EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684672 ↗
• InjuryAug 24, 2023Break; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Break; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON PERFORMED ANEURYSM EMBOLIZATION, USING ECHELON-10 (MODEL: 145-5091-150, LOT NUMBER: B50 5914) TUBE FOR COIL EMBOLIZATION. AFTER 5 COILS OF NORMAL EMBOLIZATION, CHOSE TO USE THE APB-2-4-HX-ES COIL TO FINISH. AFTER NORMAL HYDRATION OUTSIDE THE BODY, STARTED TO DELIVER THE COIL, AND STARTED FILLING AFTER IT WAS IN PLACE. WHEN ADJUSTING THE POSITION OF THE SPRING COIL, IT WAS FOUND THAT THE SPRING COIL HAD BEEN ACCIDENTALLY DETACHED. SOME OF THE BODY OF THE COIL HERNIATED OUT OF THE PARENT BLOOD VESSEL, AND WAS THEN FIXED WITH THE AID OF A STENT. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION AND REMAINED IN THE PATIENT. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID REPOSITION THE COIL 2 TIMES. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 5.6MM AND A 3.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S

  Patient problems: Foreign Body In Patient; Perforation of Vessels

  MAUDE report 17617643 ↗
• MalfunctionFeb 9, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL EXPERIENCED RESISTANCE IN THE SHEATH AND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT WHEN THE COIL ENTERED THE MICROCATHETER MORE THAN HALFWAY, THE END OF THE PUSH ROD GOT STUCK IN THE SHEATH AND COULD NOT BE PUSHED FOR EMBOLIZATION. AFTER THE OPERATOR EXERTED A LITTLE FORCE, THE DETACHMENT END BROKE, AND THE COIL FELL INTO THE MICROCATHETER. IT WAS WITHDRAWN, REPLACED WITH A NEW MICROCATHETER, AND EMBOLIZED AGAIN. THE OPERATION WAS SUCCESSFULLY COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16337113 ↗
• MalfunctionJun 22, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH AND MANUAL DETACHMENT DID NOT WORK EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14783982 ↗