AxiumTM APB-2.5-6-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536021051), received between Apr 10, 2019 and Jan 26, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME COIL HAD POOR DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE INSTANT DETACHER 3 TIMES, AND NO ATTEMPT WAS MADE TO WITHDRAW (DETACH) USING ANOTHER INSTANT DETACHER OR MANUALLY VIA THE HYPOTUBE. IT WAS REPORTED THAT THERE WERE NO DEFECTS WITH THE INSTANT DETACHER. THE COIL WAS REPLACED WITH A ANOTHER APB COIL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182971 ↗
• MalfunctionOct 17, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS HAD DIFFICULTY DETACHING. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMMUNICATING ANEURYSM WITH A MAX DIAMETER OF 6.5 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY SHOWED NO ABNORMALITIES. IT WAS REPORTED THAT THE AXIUM COIL COULD NOT BE DETACHED AND WAS REPLACED WITH A NEW AXIUM COIL. IT WAS REPORTED THAT THE NEW AXIUM COIL ALSO COULD NOT BE DETACHED AT FIRST, BUT SUCCESSFUL DETACHMENT WAS ACHIEVED USING THE EMERGENCY DETACH SYSTEM. NO ADVERSE HEALTH EFFECTS OCCURRED. THE PHYSICIAN ATTEMPTED TO WITHDRAW USING ANOTHER INSTANT DETACHER. THE PHYSICIAN DID NOT ATTEMPT TO WITHDRAW USING ANOTHER INSTANT DETACHER. THERE WAS ONE ATTEMPT TO REMOVE THE DEVICE MANUALLY VIA THE HYPOTUBE. 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. ANCILLARY DEVICES INCLUDE AN INSTANT DETACHER SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328876 ↗
• MalfunctionMar 18, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE IN THE CATHETER AND THE PUSH WIRE WAS KINKED. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY ( ACOM) WITH A MAX DIAMETER OF 4.8 MM AND A 1.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT PATIENT HAS A NORMAL BP LEVEL WITH MODERATE VESSEL TORTUOSITY. THE SHEATH, GUIDE CATHETER AND MICRO CATHETER WAS PARKED APPROPRIATELY. FIRST COIL WAS DEPLOYED AND SECOND EV3 COIL (APB-2.5-6-HX-ES LOT 226870613) COIL WAS TAKEN. PHYSICIAN HAS STARTED EXPERIENCING RESISTANCE WHILE ADVANCING THE COIL INTO THE MICROCATHETER AND PUSHER WIRE WAS KINKED. COIL WAS RESHEATHED AND COMPETITOR COIL WAS DEPLOYED. IT WAS REPORTED THE PUSHER WAS KINKED/BROKEN. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. THE DAMAGE WAS LOCATED IN THE PUSH WIRE MIDDLE SEGMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920259 ↗
• InjuryFeb 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT REGARDING AN AXIUM COIL THAT PREMATURELY DETACHED AND REMAINS IN THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHILE COILING THE ANTERIOR COMMUNICATING ARTERY ANEURYSM 2.5-6 COIL WAS TAKEN AFTER THE FIRST COIL 4-10 MM, WHEN 2,3 LOOPS WENT INSIDE THE ANEURYSM COIL AND GOT DETACHED PARTIALLY. HALF OF THE COIL IS INSIDE THE MICROCATHETER AND HALF DETACHED. TRIED TO PUSH WITH PUSHER WIRE COIL DID NOT WENT INSIDE. COULD NOT BE TAKEN OUT AS WELL. IT WAS REPORTED THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE IMPLANT COIL REMAINS IN THE PATIENT. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. THE TREATMENT PLAN TO SECURE THE COIL IS TO KEEP THE PATIENT ON AN ANTIPLATELET. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE IS 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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16385632 ↗
• MalfunctionJun 28, 2022Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE CUT WHEN TRYING TO DETACH WITH A DETACHER SO IT WAS COLLECTED. NO EMERGENCY DETACHMENT MECHANISM WAS USED. THE COIL WAS COLLECTED THROUGH THE MICROCATHETER AND REMOVED FROM THE PATIENT'S BODY. THERE WAS NO RESISTANCE DURING DELIVERY. THE COIL WAS NOT REPOSITIONED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL USING THE MANUAL METHOD. THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT'S BODY. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ANCILLARY DEVICES INCLUDE: SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846876 ↗
• MalfunctionMar 20, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD NOT REACHED THE DETACHED MARK POINT, AUTOMATICALLY DETACHED IN ADVANCE. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE OPHTHALMIC ARTERY. THE MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 5MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  NO SURGICAL OR MEDICAL INTERVENTION WAS 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 ATTEMPTED TO DETACH WITH THE INSTANT DETACHER 1 TIME AND 1 TIME WITH THE MANUAL METHOD. THEY DID NOT ROTATE THE DELIVERY WIRE DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13834615 ↗
• MalfunctionNov 4, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT DETACH DURING THE PROCEDURE. THE FIRST INSTANT DETACHER WAS USED OVER 3 TIMES. A SECOND INSTANT DETACHER WAS USED 2 TIMES, IN ADDITION TO THE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE USED ONCE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ICA WITH A MAX DIAMETER OF 2.8MM AND A 1.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A SL1- MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752456 ↗
• MalfunctionAug 17, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ISSUES WERE ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10413200 ↗
• MalfunctionDec 16, 2019Break; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Break; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL SHEATH AND PUSHER WERE BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED BA-TOP ANEURYSM WITH A MAX DIAMETER OF 8MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN PUSHING THE COIL OUT OF THE HOOP, THE SHEATH WAS BROKEN/STUCK IN THE SHEATH. DURING CHECKING, IT WAS CONFIRMED THAT THE DELIVERY PUSHER WAS ALSO BROKEN. THEREFORE, THE PRODUCT WAS RETRIEVED WITHOUT USING. 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 Known Impact Or Consequence To Patient

  MAUDE report 9475053 ↗
• MalfunctionMay 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING BALLOON ASSISTED COILING EMBOLIZATION TREATMENT OF A RUPTURED SACCULAR ANEURYSM MEASURING 6.0MM X 4.5MM LOCATED IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND THE VASCULATURE WAS ALSO NORMAL IN TORTUOSITY. THERE ARE NO IMAGES FOR REVIEW. THE PHYSICIAN HAD MEASURED THE ANEURYSM AND CHOSE THE SIZE OF THE COILS. TWO COILS WERE PLACED WITHOUT ISSUES. DURING PLACEMENT OF THE NEXT, THE COIL WAS DEPLOYED BUT WAS FOUND PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE COIL AND CATHETER WERE REMOVED TOGETHER. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8656374 ↗
• MalfunctionApr 10, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION FOR A FUSIFORM ANEURYSM IN THE DISTAL INTERNAL CAROTID ARTERY (ICA). IT WAS NOTED THAT THE BLOOD FLOW WAS NORMAL AND THE VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, THE AXIUM COIL FAILED TO DETACH FOUR TIMES USING AN INSTANT DETACHER. AFTERWARD, MANUAL DETACHMENT WAS ATTEMPTED AND FAILED ON THE FIRST ATTEMPT. THE SECOND MANUAL DETACHMENT ATTEMPT WAS SUCCESSFUL. THE AXIUM WAS ABLE TO BE PLACED. THE PUSHWIRE WAS REMOVED AND THERE WAS REPORTEDLY NO DAMAGE TO IT. NO OTHER ISSUES WERE NOTED BEFORE OR AFTER NON-DETACHMENT. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8500778 ↗