Axium Prime Detachable Coil System APB-2.5-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000313708), received between Jun 28, 2023 and Mar 26, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS FOUND DAMAGED OUT OF BOX. THE ON-SITE CONTACT PERSON REPORTED THAT AFTER THE CUSTOMER UNPACKED THE PACKAGE, IT WAS FOUND THAT THE SPRING COIL DETACHMENT POINT HAD BROKEN. ALL DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698809 ↗
• MalfunctionMar 18, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL COULD NOT BE DETACHED. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626659 ↗
• InjuryMar 9, 2026Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION OF THE DEVICE. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED. IT WAS CONFIRMED THAT THE INSTANT DETACHER WAS NOT USED. THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EVENT OR INJURY IN ASSOCIATION WITH THE EVENT. THE PATIENT IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Foreign Body In Patient

  MAUDE report 24545103 ↗
• MalfunctionJan 16, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS IN THE ANTERIOR CEREBRAL ARTERY (ACA). VESSEL TORTUOSITY WAS NORMAL. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE REPORTED AXIUM ISSUE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. MORE THAN TWO INSTANT DETACHERS (ID-1-5) WERE USED. FOR DEVICE APB-2.5-4-3D-ES, ALTHOUGH THERE WAS AN INITIAL NON-DETACHMENT, THE DEVICE WAS EVENTUALLY DETACHED AFTER SEVERAL ATTEMPTS USING THE BACKUP DETACHMENT METHOD. FOR DEVICE APB-1.5-2-3D-ES, THE COIL WAS ALSO EVENTUALLY DETACHED AFTER SEVERAL ATTEMPTS USING THE BACKUP DETACHMENT METHOD; HOWEVER, DETACHMENT OCCURRED AT AN UNINTENDED TIME, RESULTING IN MIGRATION OF THE DEVICE TO AN UNINTENDED LOCATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24093283 ↗
• MalfunctionJan 9, 2026Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT INTERNAL CAROTID ARTERY (R-ICA) POSTERIOR COMMUNICATING (PCOM) SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 2MM AND THE NECK DIAMETER WAS 1.4MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING COIL PLACEMENT, THE ECHELON MI CROCATHETER WAS PUSHED OUT OF POSITION. THE SURGEON WANTED TO WITHDRAW THE COIL TO REPOSITION THE MICROCATHETER. HOWEVER, IT WAS FOUND THAT THE COIL PUSHER WAS STUCK IN THE SHEATH AND COULD NOT BE ADVANCED OR WITHDRAWN. THE DEVICES WERE REPLACED TO CONTINUE THE PR OCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021566 ↗
• MalfunctionDec 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AXIUM COIL EXPERIENCED RESISTANCE IN THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6MM. IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE SURGEON DELIVERED THE AXIUM COIL AFTER THE ECHELON MICROCATHETER WAS IN PLACE. DESPITE REPEATED ATTEMPTS, THE COIL TIP COULD NOT REACH THE PROXIMAL END OF THE MICROCATHETER. THE SURGEON REPLACED THE AXIUM COIL WITH ANOTHER AXIUM COIL AND TRIED AGAIN, BUT AGAIN, IT COULD NOT REACH THE PROXIMAL END OF THE MICROCATHETER. AFTER REPLACING THE MICROCATHETER AND BOTH COILS, THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER AND AN ADDITIONAL AXIUM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794712 ↗
• MalfunctionJul 2, 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 THE PATIENT WAS UNDERGOING TREATMENT OF AN AMORPHOUS, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 2.8MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE ANEURYSM COILING PROCEDURE, THE DOCTOR SUCCESSFULLY DEPLOYED 2 COILS. WHILE DEPLOYING THE 3 COILS, THE PHYSICIAN FOUND THAT THE PUSHER WIRE OR DELIVERY WIRE OF THE AXIUM COIL WAS BENT AND KINKED UNINTENTIONALLY, AND WHILE PUSHING THE COIL INTO THE MICROCATHETER, THE COILS GOT DETACHED. IT WAS UNKNOWN WHETHER THERE WAS ANY FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, OR ATTEMPT TO DETACH THE COIL, AND DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE IMPLANT COIL WAS REMOVED FROM THE PATIENT USING THE SNARE DEVICE. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391436 ↗
• MalfunctionMar 24, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. THERE WERE NO ISSUES PRIOR TO THE NON-DETACHMENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678065 ↗
• MalfunctionJan 16, 2025Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL SEPARATED. DURING THE IMPLANTATION PROCESS, THE COIL TIP END WAS FOUND TO HAVE FALLEN OFF AND COULD NOT BE IMPLANTED NORMALLY. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE COIL WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. 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. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE MAX DIAMETER WSA 3.65MM AND THE NECK DIAMETER WAS 3.8MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170587 ↗
• MalfunctionJan 13, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE IN THE ECHELON 10 MICROCATHETER AND THE CATHETER WAS DAMAGED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA). THE ANEURYSM MAX DIAMETER WAS 3MM AND A NECK DIAMETER OF 1MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AN AXIUM PRIME COIL COULD NOT BE ADVANCED THROUGH THE DISTAL ECHELON MICROCATHETER. THE COIL WAS REPLACED WITH ANOTHER AXIUM COIL BUT THE SAME ISSUE OCCURRED SO THE SYSTEM WAS REMOVED. THE CATHETER WAS OBSERVED TO BE DAMAGED AT THE DISTAL END. NEITHER COIL WAS DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO DETACHMENT ATTEMPTS WERE MADE. THE COIL ACCIDENTALLY BROKE DURING PROCEDURE. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE. IT WAS UNKNOWN IF THE COIL PREMATURELY DETACH IN THE CATHETER. THE PATIENT WAS BEING FOLLOWED UP WITH CLOSELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145915 ↗
• MalfunctionJan 9, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE FIRST SPRING COIL 6-15 ENTERED THE MICROCATHETER, IT COULD NOT BE PUSHED OR WITHDRAWN. THE WHOLE WAS WITHDRAWN FROM THE BODY. THE MICROCATHETER AND THE SPRING COIL BODY WERE FOUND TO BE DAMAGED. IT WAS REPLACED WITH A NEW MICROCATHETER AND THE SPRING COIL WAS DELIVERED. WHEN DELIVERING THE 2.5-4 SPRING COIL, THE RESISTANCE WAS FOUND TO BE LARGER, AND THE SPRING COIL WAS WITHDRAWN FROM THE BODY AND THE COIL BODY WAS FOUND TO BE DAMAGED. RESISTANCE HAD BEEN IN THE MIDDLE SEGMENT OF THE CATHETER. THERE WERE NO SYMPTOMS REPORTED. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS BEING TREATED FOR A SACCULAR, UNRUPTURED ANEURYSM IN C4 WITH A MAX DIAMETER OF 6MM AND A NECK DIAMETER OF 2MM. BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 10MM DIAMETER. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE/DAMAGE WAS NOT DETERMINED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. BESIDES THE RESISTANCE, THERE WERE NO OTHER ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118893 ↗
• MalfunctionNov 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE IMPLANTATION PROCESS OF THE AXIUM COIL, THE AXIUM COIL AT THE TIP END FELL OFF AND COULD NOT BE IMPLANTED NORMALLY. THE COIL WAS PULLED OUT WITH A PUSH ROD. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH A MAX DI AMETER OF 3.5MM AND A 3.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18169797 ↗
• MalfunctionOct 26, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL DID NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS NOT DETACHED DURING THE COIL PROCEDURE, HCP TRIED TO DETACH MORE 3 TIMES USED THE INSTANT DETACHER AND COIL WAS NOT DETACHED, NEVERTHELESS TRIED MANUAL DETACH METHOD. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES. THE PHYSICIAN DID TRY TO DETACH WITH ANOTHER INSTANT DETACHER WITH TWO ATTEMPTS. THERE WAS ONE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE IS NO ISSUE WITH THE 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 18015886 ↗
• MalfunctionOct 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE AT CATHETER'S HUB WHEN HEALTHCARE PROVIDER (HCP) PUT IN THE COIL,  SO THE HCP USED NEW COIL (THE SAME SIZE) AND PROCEDURE COMPLETED WELL. THERE IS NO PATIENT INVOLVED IN THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930494 ↗
• MalfunctionJun 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITONAL INFORMATION RECEIVED REPORTED NO DETACHMENT ATTEMPT WAS MADE, COIL DETACHED BY ITSELF. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218157 ↗