AxiumTM APB-2-6-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00847536021013), received between Apr 4, 2019 and Nov 25, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS UNDERGOING THE PROCEDURE TO TREAT A 6.1MM MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. A CONTINUOUS FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE AS INDICATED IN THE IFU. IT WAS CLARIFIED THAT WHEN RETRIEVING THE COIL, IT WAS STUCK IN THE MICROCATHETER SO THE SYSTEM WAS REMOVED TOGETHER. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS NOTED TO BE RECOVERING WITH NO PROBLEM. AFTER REMOVAL, IT WAS OBSERVED THE COIL WAS ELONGATED/STRETCHED AND THE FILAMENT WAS EXPOSED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645028 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS DETACHED PREMATURELY. IT WAS REPORTED THAT WHEN TAKING THE COIL FROM THE HOOP, IT DETACHED AND FELL ON THE FLOOR IN THE OPERATING ROOM. THERE HAD NOT BEEN ANY FRICTION OR OTHER DIFFICULTY. NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL. THE DELIVERY PUSHER WAS NOT ROTATED. THE COIL HAD NOT BEEN REPOSITIONED. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. IT WAS NOTED THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE ISSUE OCCURRED PRIOR TO USE; THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786020 ↗
• MalfunctionJul 14, 2025Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION REGARDING ISSUES THAT OCCURRED DURING A STENT ASSISTED COIL EMBOLIZATION PROCEDURE IN WHICH MULTIPLE AXIUM COIL WERE USED WITH A SOLITAIRE AB (SAB) STENT. THE PATIENT WAS UNDERGOING A STENT ASSISTED COIL EMBOLIZATION PROCEDURE TO TREAT AN ANTERIOR CEREBRAL ARTERY (ACA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS NAVIGATED IN PLACE AND THE SOLITAIRE AB STENT WAS DELIVERED AND DEPLOYED. FIVE AXIUM COILS OF DIFFERENT MODELS/SIZES WERE SUCCESSFULLY IMPLANTED. DURING DEPLOYMENT OF THE AXIUM COIL (MODEL: APB-2-6-HX-ES, LOT: 227440067), THE COIL STRETCHED, SO IT WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. DURING THE FINAL STAGES OF THE PROCEDURE, REPEATED ATTEMPTS TO DETACH THE SOLITAIRE AB STENT WERE UNSUCCESSFUL SO THE STENT WAS WITHDRAWN. DUE TO POTENTIAL SAFETY CONCERNS, IT WAS DECIDED NOT TO IMPLANT A STENT AND THE PROCEDURE WAS CONCLUDED AND CONSIDERED SUCCESSFUL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500471 ↗
• MalfunctionJan 8, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED NO INSTANT DETACHER USED. THREE ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105969 ↗
• MalfunctionDec 29, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING AND INSTANT DETACHER THAT WOULD NOT DETACH THE COIL. IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER FIVE TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT MADE AT DETACHMENT VIA HYPOTUBE. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. ANCILLARY DEVICES INCLUDE A SL10 MICROCATHETER. NEW INFORMATION WAS RECEIVED. THE COIL WAS A MEDTRONIC PRODUCT. APB-2-6-HX-ES LOT:223109275. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT OR INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16072741 ↗
• MalfunctionDec 29, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING AND INSTANT DETACHER THAT WOULD NOT DETACH THE COIL. IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED USING THE DETACHER. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER SEVEN TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT MADE AT DETACHMENT VIA HYPOTUBE. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. ANCILLARY DEVICES INCLUDE A SL10 MICROCATHETER. NEW INFORMATION WAS RECEIVED. THE COILS WERE A MEDTRONIC PRODUCT; APB-2-6-HX-ES LOT #: 223109275.THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT OR INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16071004 ↗
• MalfunctionOct 25, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL FAILED TO DETACH. DUE TO COIL DETACHMENT FAILURE, IT COULD NOT BE DETACHED, SO IT WAS COLLECTED. THE EMERGENCY WITHDRAWAL MECHANISM WAS ALSO ATTEMPTED, BUT IT DID NOT APPEAR THAT THE COIL WAS COMPLETELY SEPARATED, SO IT WAS COLLECTED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL 3 TIMES WITH THE INSTANT DETACHER. ANOTHER INSTANT DETACHER WAS NOT USED. TWO MANUAL ATTEMPTS WERE MADE TO DETACH THE COIL VIA THE HYPOTUBE. IT WAS REPORTED THE EVENT WAS NOT ASSOCIATED WITH A PATIENT.  ANCILLARY DEVICES: SL-10 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15669841 ↗
• MalfunctionSep 26, 2022Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL EXPERIENCED RESISTANCE IN THE DISTAL PART OF THE ECHELON 10 MICROCATHETER DURING DELIVERY AND PREMATURELY DETACHED IN THE CATHETER AFTER BEING UNABLE TO BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ICA. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE COIL WAS THE SECOND ONE USED IN THE PROCEDURE. THE COIL FACED SOME RESISTANCE WHILE PUSHING, BUT IT REACHED THE TARGET LOCATION. THE COIL WAS THEN UNABLE TO BE DETACHED USING THE INSTANT DETACHER. AFTER TWO ATTEMPTS, THE PHYSICIAN TRIED DETACHING MANUALLY. THE COIL STILL DID NOT DETACH, SO THEY TRIED TO PULL IT BACK. ON TAKING THE PUSHER WIRE OUTSIDE, THE PHYSICIAN NOTICED THE COIL HAD NOT COME ALONG AND MUST HAVE BEEN DETACHED SOMEWHERE IN MICROCATHETER, WHICH WAS LATER OBSERVED IN FLUORO. THE MICROCATHETER WAS PULLED BACK AND WAS FLUSHED TO RETRIEVE THE DETACHED COIL. THERE WAS NO DAMAGE TO THE CATHETER, AND IT WAS USED FOR FURTHER COILING. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486794 ↗
• MalfunctionAug 16, 2022Detachment of Device or Device Component; Material Deformation; Packaging Problem; Detachment of Device or Device Component; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT ONCE THE PACKAGE WAS OPENED, THE AXIUM COIL PUSHWIRE WAS OBSERVED TO BE KINKED. THE COIL WAS PUSHED OUT AND FOUND TO BE ALREADY DETACHED. IT WAS NOTED THE DEVICE WAS PREPARED PER IFU BUT WAS NOT USED IN THE PROCEDURE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234503 ↗
• MalfunctionJul 5, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS STUCK IN THE CENTER OF THE MICROCATHETER. WHILE PULLING IT BACK, IT BROKE INTO 2 PIECES CONSECUTIVELY. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE COIL PIECES WERE ABLE TO BE REMOVED WITH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914825 ↗
• InjuryJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR CAVERNOUS SINUS SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL. DURING THE FILLING PROCESS, THE COIL DETACHED PREMATURE AND WAS IMPLANTED AT AN UNINTENDED LOCATION. IT WAS NOTED THAT THE PHYSICIAN HAD REPOSITIONED THE COIL 1 TIME BUT DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE AND HAD NOT MADE ANY ATTEMPT TO DETACH THE COIL. THE PUSHWIRE WAS NOT BENT OR BROKEN. A SOLITAIRE AB STENT WAS THEN IMPLANTED TO SECURE THE COIL. POST-OPERATIVELY THE PATIENT WAS OBSERVED TO HAVE INTRACRANIAL HEMORRHAGE AND A CRANIOTOMY PROCEDURE WAS PERFORMED TO CLEAR THE HEMA TOMA.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 14802479 ↗
• MalfunctionMay 6, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS STUCK IN THE CENTER OF THE MICROCATHETER. WHILE PULLING IT BACK, IT BROKE INTO 2 PIECES CONSECUTIVELY. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307238 ↗
• MalfunctionJul 11, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT FOUR DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND THREE WERE MADE WITH THE MANUAL METHOD. NO ISSUES WERE ENCOUNTERED PRIOR TO NON-DETACHMENT, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148296 ↗
• MalfunctionMar 19, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530074 ↗
• MalfunctionSep 8, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE BATOP 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 MODERATE. IT WAS REPORTED THAT AN SL-10 MICROCATHETER WAS PLACED, AND THE COIL RECANALIZATION PROCEDURE WAS PERFORMED. TWO AXIUM COILS EXPERIENCED THE SAME NON-DETACHMENT ISSUES. THE COILS WERE ATTEMPTED TO BE DETACHED FIVE TIMES WITH THE INSTANT DETACHER, BUT IT FAILED. ANOTHER INSTANT DETACHER WAS NOT USED, THE MANUAL DETACHMENT METHOD WAS PERFORMED TWICE, BUT THE COILS STILL DID NOT DETACH. IT WAS STATED THERE WERE NO ISSUES WITH THE INSTANT DETACHER, AND THE COILS WERE THEN RETRIEVED WITHOUT FURTHER ACTIONS. DETACHMENT OF COILS WAS SUCCESSFULLY DONE BEFORE AND AFTER THE ISSUE. 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 Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10505220 ↗
• MalfunctionFeb 5, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING THE COIL PROCEDURE, THE AXIUM PRIME COIL FAILED TO DETACH. REPEATED DETACHMENT ATTEMPTS (5 TIMES) WERE MADE WITH ID-1-5, BUT IT FAILED. 2 MANUAL DETACHMENT ATTEMPTS ALSO FAILED TO SEPARATE THE COIL. THE PUSHWIRE WAS PUSHED A LITTLE, AND THE TENSION WAS APPLIED, BUT IT STILL FAILED. WHEN THE DEVICE WAS BEING RETRIEVED (WITHOUT ANY ACTION) IT BROKE INSIDE THE ANEURYSM. IT IS UNKNOWN IF THE INSTANT DETACHER WAS THE PROBLEM. A SECOND INSTANT DETACHER WAS NOT USED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USED (IFU). THE PATIENT WAS TREATED FOR A RIGHT INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY, UNRUPTURED ANEURYSM THAT WAS SACCULAR. THE MAX DIAMETER WAS 4 MM AND THE NECK WAS 4 MM. THE BLOOD FLOW WAS NORMAL, AND THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9670610 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT 2 PIPELINE FLEX WITH SHIELD (PED2) WERE USED TO RE-TREAT A NECK RECURRENCE (2 X 3 X 3MM) OF A RUPTURED AND COILED PCOMA-ANEURYSM (INITIALLY 8X5X4,5 MM).

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8744929 ↗
• MalfunctionApr 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED IN THE MICROCATHETER FOR A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM COIL EMBOLIZATION, AND THEN THE MICROCATHETER AND COIL WAS REMOVED COMPLETELY. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKE. THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL AND DID NOT ATTEMPT TO DETACH THE COIL. THEY ALSO DID ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484361 ↗