AxiumTM APB-4-8-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536008168), received between Oct 10, 2018 and Apr 29, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING COIL EMBOLIZATION THROUGH A MICROCATHETER, WHEN DETACHMENT WAS ATTEMPTED, THE AXIUM PRIME COIL COULD NOT BE DETACHED PROPERLY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE FACILITY CONSIDERS IT TO BE A PRODUCT DEFECT OF EITHER THE COIL OR THE DETACHER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF A RUPTURED, SACCULAR, RIGHT IC (INTERNAL CAROTID) OPHTHALMIC SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 2 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). "POOR DISLODGEMENT" WAS NOTED. THREE ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. IT WAS UNKNOWN IF ANY MANUAL DETACHMENT ATTEMPTS WERE MADE VIA THE HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033900 ↗
• MalfunctionOct 20, 2025Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL WAS IMPLANTED DURING ANEURYSM EMBOLIZATION SURGERY. IT WAS FOUND THAT THE SPRING COIL WAS STRETCHED DURING DELIVERY. IT WAS THEN REMOVED FROM THE BODY. THE DEVICE AND ANY ACCESSORIES 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 LEFT C5 ANEURYSM WITH A MAX DIAMETER OF 5.5 MM AND A 3.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH A NEW SPRING COIL. THE CAUSE OF THE COIL STRETCH WAS NOT DETERMINED. NO ISSUES WERE IDENTIFIED THAT COULD HAVE RESULTED IN THE OBSERVED DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337678 ↗
• MalfunctionFeb 6, 2025Break; Separation Failure; Break; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ISSUES WITH THE PHENOM CATHETER. THERE WAS NO RESISTANCE DURING INSERTING AND IT SEEMED TO HAVE BEEN STUCK WHEN IT WAS BEING COLLECTED DUE TO COIL DETACH DIFFICULTY. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO DAMAGES OTHER THAN THE PART WHERE THE EMERGENCY DETACH WAS PERFORMED.

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

  MAUDE report 21321751 ↗
• MalfunctionJan 9, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE COIL RESISTANCE/BREAK WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WERE ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND; IT IS BELIEVED THAT THE DAMAGE WAS CAUSED BY STUCK INSIDE THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111878 ↗
• MalfunctionOct 9, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE THE INSTANT DETACHER TO DETACH THE COIL, BUT THE COIL DID NOT DETACH. THE METHOD OF EMERGENCY MANUAL DETACHMENT WAS ALSO TRIED, BUT THE COIL DID NOT DETACH. EVEN WHEN THE WIRE WAS MOVED, ETC., IT STILL DID NOT DETACH. A SECOND INSTANT DETACHER WAS NOT USED, AS THERE WAS SAID TO BE NO ISSUES WITH IT. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413608 ↗
• MalfunctionAug 23, 2024Inadequacy of Device Shape and/or Size; Stretched; Inadequacy of Device Shape and/or Size; Stretched

  MEDTRONIC RECEIVED REPORT THAT AFTER THE FIRST COIL HAD BEEN DELIVERED AND DEPLOYED SUCCESSFULLY TO FORM THE HOOP, THE AXIUM COIL (MODEL: APB-4-8-SS, LOT: 228091510) WAS DELIVERED FOR FILLING. HOWEVER, IT WAS REPORTED THAT THE COIL DEVELOPMENT WAS ABNORMAL DESPITE THERE BEING NO FEELING OF ABNORMALITY DURING DELIVERY. THE COIL WAS WITHDRAWN AND REDELIVERED BUT STILL WAS NOT SHAPED NORMALLY SO IT WAS WITHDRAWN FROM THE PATIENT'S BODY AND FOUND TO BE STRETCHED IN THE "PUSHWIRE MIDDLE SEGMENT." IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE. THERE WAS NO OBSERVED FRICTION OR OTHER DIFFICULT DURING TESTING OR DELIVERY OF THE COIL. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. ANCILLARY DEVICES: COOK SHEATH, ECHELON MICROCATHETER, AVIGO GUIDEWIRE THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN LEFT INTERNAL CAROTID ARTERY (L-ICA) OPHTHALMIC SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 2.6MM. BLOOD FLOW AND VESSEL TOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052127 ↗
• MalfunctionMay 10, 2023Use of Device Problem; Separation Failure; Use of Device Problem; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL COULD NOT BE DETACHED. WHEN THE HYPOTUBE WAS BROKEN AS THE HEALTHCARE PROVIDER (HCP) ALWAYS DOES, THERE WAS NO INNER WIRE TO PULL AND DETACH THE COIL. SO THE COIL CAN NOT BE DETACHED AND WAS ABLE TO BE PULLED OUT OF THE ANEURYSM. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907324 ↗
• InjuryMar 28, 2023Stretched; Unintended Movement; Stretched; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PART OF STRETCHED COIL WAS REMAINED IN THE PATIENT¿S BODY FROM BRAIN TO NEARBY STOMACH. I CHECKED THE STATE OF THE PATIENT AS SOON AS KNOWING THE ISSUE, AND THE PATIENT RECOVERED WELL(NO COMPLICATION RELATED TO THE REMAINED COIL). THE PATIENT DIDN¿T EXPERIENCE ANY SYMPTOM RELATED TO THE COIL STRETCH YET. THE ANATOMICAL LOCATION OF THE COIL WAS LT. MCA SAH, ABOUT 4MM-SIZED RUPTURED ANEURYSM. THE COIL PLACED IN THE CORRECT LOCATION. THE STATE OF THE PATIENT IS WELL, SO THERE IS NO FUTURE PLAN TO REMOVE THE REST OF THE STRETCHED COIL YET. ACCORDING TO THE DOCTOR, THE VESSEL WAS NOT TORTUOUS ENOUGH TO MAKE THE STRETCH AND HE DIDN¿T MAKE THE SEVERAL MOVEMENTS OF THE COIL DURING PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16627588 ↗
• MalfunctionApr 1, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT A THE AXIUM COIL COULD NOT BE DETACHED USING THE DETACHER AND WHEN TRIED TO DETACH USING THE EMERGENCY SEPARATION MECHANISM. THE COIL DETACHED WHEN WHEN THE DELIVERY WIRE WAS PULLED INTO THE MICROCATHETER, IT WAS REPORTED THERE WAS NO PATIENT WAS INVOLVED IN THIS EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT.  THE PHYSICIAN TRIED TO DETACHED COIL WITH THE INSTANT DETACHER 2 TO 3 TIMES. THEY DID NOT TRY WITH ANOTHER INSTANT DETACHER. THEY TRIED ONE TIME WITH A MANUAL ATTEMPT VIA A HYPOTUBE. ANCILLARY DEVICES: HEADWAY MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981283 ↗
• MalfunctionMar 29, 2021Stretched; Separation Failure; Stretched; Separation Failure

  ADDITIONAL INFORMATION REPORTED IT WAS SAID THAT IT WAS A SNARE OF 4MM. THE PRODUCT WAS MISTAKENLY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581762 ↗
• MalfunctionJan 22, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE COIL MIGRATION WAS THAT THE SECOND COIL DISLODGED THE FIRST COIL. THE MIGRATED COIL WAS LEFT IN THE PATIENT'S BODY AND A WEB WAS IMPLANTED INTO THE ANEURYSM. THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11216582 ↗
• MalfunctionJan 5, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE FAILED TO DETACH. THREE DETACHMENT ATTEMPTS WERE MADE WITH AN INSTANT DETACHER, BUT A SECOND INSTANT DETACHER WAS NOT USED. THERE WERE NO MANUAL DETACHMENT ATTEMPTS MADE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. AS A RESULT OF THE ISSUE THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117615 ↗
• MalfunctionOct 30, 2020Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DID NOT DETACH WITH THE INSTANT DETACHER (ID) AND THEN HAD A BREAK OF THE PUSHER. THE PATIENT WAS BEING TREATED WITH COIL EMBOLIZATION FOR A RUPTURED SACCULAR ANEURYSM OF AN ANTERIOR COMMUNICATING ARTERY (A-COM) WITH SUBARACHNOID HEMORRHAGE. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE MICROCATHETER WAS NAVIGATED TO THE TARGET LOCATION WITHOUT ISSUE. IT WAS NOTED THAT THERE WAS NO DEFECT OF THE MICROCATHETER. THE REPORTED AXIUM COIL WAS THE FIRST TO BE USED IN THE PROCEDURE. IT WAS DELIVERED THROUGH THE MICROCATHETER AND IMPLANTED WITHIN THE ANEURYSM AS PLANNED. HOWEVER, WHEN THE ATTEMPT WAS MADE TO DETACH THE COIL WITH THE ID, THE COIL WAS NOT DETACHED. WHEN THE HYPOTUBE MANUAL DETACHMENT METHOD WAS TRIED, THE PUSHER BROKE RATHER THAN THE COIL DETACHING. THE COIL WAS RETRIEVED REPLACED AN AXIUM COIL OF ANOTHER MODEL AND SIZE WHICH WAS IMPLANTED AND DETACHED SUCCESSFULLY WITH THE SAME ID. NON-MEDTRONIC COILS WERE THEN USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. IT WAS NOTED THAT THERE WAS NO DEFECT OF THE ID. AL

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10764176 ↗
• MalfunctionNov 19, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING AN ANEURYSM COILING PROCEDURE, THE COIL FAILED TO DETACH FROM THE PUSH-WIRE. ALTERNATIVE DETACHMENT METHODS WERE ATTEMPTED WITHOUT SUCCESS. TWO INSTANT DETACHES WERE USED, EACH 4 TIMES TO ATTEMPT TO DETACH THE COIL. MANUAL METHOD WAS ATTEMPTED 4 TIMES. THE ANATOMY WAS NORMAL. THE ACOM ANEURYSM WAS UNRUPTURED WITH A 6MM MAX AND 2MM NECK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085488 ↗
• MalfunctionOct 10, 2018Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PROXIMAL PART OF THE WIRE BROKE WHEN BEING ADVANCE INTO THE CATHETER. AS A RESULT THE PATIENT WAS TREATED WITH ANOTHER DEVICE. THE PATIENT WAS UNDERGOING SURGERY TO TREAT A CEREBRAL ANEURYSM. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7951452 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab