Axium Prime Detachable Coil System APB-3-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000313722), received between Jun 5, 2023 and Jan 13, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Detachment of Device or Device Component; Material Deformation; Unintended Movement; Migration; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATOR PLANNED TO PERFORM INTRACRANIAL ANEURYSM EMBOLIZATION USING COIL (WITH A STENT PREPARED FOR ASSISTANCE). AFTER FILLING (DEPLOYING) THE AXIUM PRIME BARE 3D COIL, IT FAILED TO STABILIZE. THE OPERATOR ATTEMPTED TO RETRIEVE THE COIL AND REDO THE EMBOLIZATION BUT FOUND THAT THE COIL SEEMED TO BE STUCK AND COULD NOT BE RETRIEVED. ATTEMPTS TO WITHDRAW THE MICROCATHETER AND THE COIL RESULTED IN THE COIL DETACHING FROM THE PUSH ROD. COIL SEPARATION/BREAK/PREMATURE DETACHMENT WAS REPORTED. THE OPERATOR USED ANOTHER MICROCATHETER TO SECURE/REMOVE THE COIL WITH A STENT AND REMOVED THE ENTIRE SYSTEM TOGETHER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING COIL DELIVERY. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ADDITIONALLY, PREMATURE TIP DETACHMENT WAS REPORTED FOR AN ECHELON 10 MICROCATHETER. THERE WAS FRICTION OR DIFFICULTY DURING INJECTION AND FORCE WAS APPLIED DURING REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED/STUCK, THERE WAS NO VASOSPASM, AND N

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

  MAUDE report 24057009 ↗
• MalfunctionJul 10, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORTED THAT THE AXIUM COIL COULD NOT BE DELIVERED THROUGH THE ECHELON 10 MICROCATHETER AND THE PROXIMAL END OF THE COIL STRETCHED. THE SYSTEM WAS REPLACED TO CONTINUE THE PROCEDURE SUCCESSFULLY. IT WAS NOTED THAT THE DEVICES WERE PREPARED AND CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE VIA FEMORAL ACCESS TO TREAT AN INTERNAL CAROTID ARTERY (ICA) UNRUPTURED SACCULAR ANEURYSM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE RESISTANCE OCCURRED IN THE DISTAL END OF THE ECHELON MICROCATHETER. IT WAS UNKNOWN IF EITHER DEVICE WAS DAMAGED. THE CAUSE OF THE RESISTANCE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475621 ↗
• MalfunctionJan 24, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THERE WAS NO ISSUE ADVANCING COIL UNTIL AT THE ANEURYSM. PHYSICIAN WAS EXPERIENCING FRICTION AS HE WAS TRYING TO ADVANCE THE COIL INTO THE ANEURYSM. IT WAS DISCUSSED THAT PREVIOUS COIL THAT WAS DETACHED MAY HAVE BEEN PROXIMAL TO DETACHMENT ZONE THUS HAVING A TAIL IN THE MICROCATHETER THAT CAUSED FRICTION FOR THE AXIUM COIL TO ADVANCE AND POSSIBLY GETTING TANGLED WITH THE ORIGINAL COIL. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. A STRYKER SL-10 MICROCATHETER WAS USED. PUSHER WIRE AND CATHETER WERE RETRIEVED BUT DO NOT HAVE LOT INFO FOR MICROCATHETER AS THAT WAS TOSSED IN TRASH. ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND INCLUDE ISSUES WITH STRETCHED COIL AND COMPLEXITY TO RETRIEVE SAFELY WHICH IN RESULT LED TO PULLING OUT ALL COIL MASS OUT OF ANEURYSM. SUCCESSFULLY RETRIEVED WITH NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21235591 ↗
• MalfunctionNov 8, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PRIOR TO NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639584 ↗
• MalfunctionJul 19, 2024Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STRETCHED AND ANOTHER THAT DETACHED PREMATURELY DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A MIDDLE CEREBRAL ARTERY (MCA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). AFTER THE MICROCATHETER WAS IN PLACE AND HOOP FORMED, THE AXIUM COIL (MODEL: APB-3-4-3D-ES, LOT: 226656023) WAS CHOSEN FOR FILLING. HOWEVER, THE TAIL END OF THE COIL WAS STRETCHED SO THE COIL WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME MODEL FOR FILLING. DURING THE SAME PROCEDURE, ANOTHER AXIUM COIL (MODEL: APB-1-4-3D-ES, LOT: 224302031) WAS SELECTED FOR FILLING THE ANEURYSM NECK. HOWEVER, THE COIL COULD NOT BE DETACHED DESPITE SEVERAL ATTEMPTS. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME MODEL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. REGARDING THE AXIUM COIL (MODEL: APB-3-4-3D-ES, LOT: 226656023), THERE WAS NO FRICTION/RESISTANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785066 ↗
• MalfunctionDec 15, 2023Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH AND WAS FOUND DAMAGED IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE SPRING COIL ES COULD NOT BE DETACHED NORMALLY DURING THE COMMUNICATING ANEURYSM OPERATION, AND THE COIL WAS RETRIEVED AND BROKEN INTO THE MICROCATHETER. IT WAS REPORTED THE COIL WAS KINKED/DAMAGED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 5 TIMES. THE PHYSICIAN DID TRY TWO MORE TIMES WITH ANOTHER INSTANT DETACHER.  THE REPORTED DEVICE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337117 ↗
• MalfunctionNov 2, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE AXIUM COIL HYDRATION, THE AXIUM COILS COULD NOT BE PUSHED OUT OF THE PROTECTIVE SHEATH. AFTER ANOTHER COIL WAS REPLACED, IT WAS PUSHED OUT OF THE PROTECTIVE SHEATH SMOOTHLY, AND THE OPERATION WAS COMPLETED SMOOTHLY. THE AXIUM COILS AND ANY ACCESSORIES 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 POSTERIOR COMMUNICATING (PCOM) ARTERY  ANEURYSM WITH A MAX DIAMETER OF 4.3MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED REPORTED 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 18059038 ↗
• MalfunctionJun 30, 2023Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN IN THE DISTAL SECTION, A PHENOM CATHETER ENCOUNTERED RESISTANCE, AND AN AXIUM COIL WAS ENTANGLED WITH THE CATHETER UPON RETRACTION WHICH RESULTED IN A MIGRATION AFTER DEPLOYMENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT C6 WITH A MAX DIAMETER OF 3.3 MM AND A 1.9 MM NECK DIAMETER. THE LANDING ZONE WAS 4.6 MM DISTALLY AND 5.2 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6 MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. ASPIRIN AND CLOPIDOGREL WERE GIVEN THREE DAYS BEFORE SURGERY EACH TIME. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED USE OF THE THIRD STENT CONTRAST TRAPPED IN ANEURYSM. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE DISTAL END OF THE STENT (LOT # B467833) COULD NOT BE OPENED AFTER THE DENSE MESH STENT WAS DEPLOYED IN THE MIDDLE CEREBRAL ARTERY. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236904 ↗
• MalfunctionJun 29, 2023Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THERE WERE NO DETACHMENT ATTEMPTS MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS REMOVED FROM THE PATIENT. THE CATHETER USED WAS AN ECHELON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224153 ↗
• MalfunctionJun 5, 2023Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL FAILED TO DETACH AND PREMATURELY DETACHED WHEN TRYING TO REMOVE THE COIL.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY (ACOM) WITH A MAX DIAMETER OF 3.4MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.  IT WAS REPORTED THAT THERE WAS A COIL DETACH ISSUE. THE CUSTOMER TRIED TO DETACH COIL WITH THE DETACHER, BUT IT WOULD NOT DETACH. AFTER THEN, THEY TRIED MANUALLY THREE TIMES WITH NO SUCCESS. WHEN TRYING TO TAKE THE COIL BACK TO MICROCATHETER FOR REMOVING IT FROM THE PATIENT'S BODY, IT WAS SUDDENLY DETACHED, SO THEY TRIED TO PUT THE COIL BACK TO ANEURYSM BY MICROWIRE AND THE PROCEDURE KEPT GOING. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER MORE THAN 3 TIMES AND DID NOT TRY DETACHMENT WITH ANOTHER INSTANT DETACHER. THERE WERE 3 MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. 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 EV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060134 ↗