AxiumTM APB-3-8-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536021099), received between Feb 11, 2019 and Apr 21, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL WHICH BROKE AND A SOLITAIRE AB (SAB) THAT FAILED TO DETACH DURING THE SAME PROCEDURE. THE PATIENT WAS UNDERGOING A STENT ASSISTED COIL EMBOLIZATION PROCEDURE TO TREAT A VERTEBRAL ARTERY (VA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK WIDTH WAS 4.11MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE AN AXIUM COIL WAS NOTED TO HAVE BROKEN OR DETACHED PREMATURELY. IT WAS NOTED THE PUSHWIRE WAS NOT BENT OR BROKEN. IT WAS UNKNOWN IF THERE WAS ANY FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. IT WAS SUCCESSFULLY REMOVED ALONG WITH THE MICROCATHETER. DURING THE SAME PROCEDURE, THE SAB COULD NOT BE DETACHED DESPITE 4 ATTEMPTS. THE DETACHMENT ZONE WAS NOT AGAINST THE VESSEL WALL. DURING DETACHMENT ATTEMPTS, THE CATHETER TIP WAS THE "STANDARD OPERATING DISTANCE" FROM THE DETACHMENT ZONE. IT WAS NOTED THE DETACHMENT BOX AND DETACHMENT CABLE WERE BRAND-NEW OUT-OF-BOX. THERE WAS NO DAMAGE TO THE DETACHMENT BOX WHICH DISPLAYED AS INDICATED IN THE IFU AND A NEW BATTERY WAS USED. A 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878086 ↗
• MalfunctionDec 27, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES PRIOR TO COIL NON-DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026860 ↗
• MalfunctionJun 21, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL DETACHED UNEXPECTEDLY.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING SEGMENT OF LEFT I NTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON FOUND THAT THE SPRING COIL COULD NOT BE PUSHED INTO THE MICROCATHETER, AND AFTER WITHDRAWING IT, IT WAS FOUND THAT IT HAD BEEN 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582918 ↗
• MalfunctionJun 4, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE HEALTHCARE PROVIDER (HCP) TOOK THE COIL OUT, THERE WAS A BUCKLE AT THE PROXIMAL PART OF THE BLACK MARKER. HCP WORRIED THAT IT MAY CAUSE PREMATURE DETACHMENT, SO HE WOULD NOT TRY TO PUT THIS COIL. AFTER THAT HCP WANTED TO SEE IF THE COIL WAS REALLY DETACHED AFTER CASE. THEY FOUND OUT IT WAS STILL INTACT AND MANUFACTURER REPRESENTATIVE (REP) TRIED THE BACK-UP DETACH METHOD TO DETACH IT TO CONFIRM. 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 INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 7MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THEY WERE UNABLE TO IDENTIFY IF THERE WERE ANY ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461781 ↗
• InjuryOct 24, 2023Stretched; Detachment of Device or Device Component; Unintended Movement; Migration; Stretched; Detachment of Device or Device Component; Unintended Movement; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS NOT SITTING IN THE VESSEL AS THE PHYSICIAN WANTED IT TO. HE WENT TO PULL THE COIL OUT, BUT IT STRETCHED AND PREMATURELY DETACHED AND REMAINED IN THE PATIENT. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED THROUGHOUT THE PROCEDURE. A COUPLE OF DAYS LATER, THE AXIUM MIGRATED INTO THE M1 AND HAD TO BE RETRIEVED WITH A SOLITAIRE. THE PATIENT IS CURRENTLY DOING WELL. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).   THE PATIENT WAS UNDERGOING SURGERY FOR EMBOLIZATION OF VESSELS FEEDING TUMOR. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.   ANCILLARY DEVICES INCLUDE A CERENOVUS MPC 5F GUIDE CATHETER, ECHELON 14 MICROCATHETER, AND A SYNCHRO SELECT GUIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17998533 ↗
• MalfunctionOct 5, 2023Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE AT THE HUB OF THE MICROCATHETER WHILE DELIVERING THE AXIUM COIL. THE DISTAL END OF THE AXIUM COIL WAS BENT. THE AXIUM COIL WAS NOT USED AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THE AXIUM COIL 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. ANCILLARY DEVICES INCLUDE A NAVIEN 6F GUIDE CATHETER, A PHENOM 17-90 MICROCATHETER, A SL10-ST MICROCATHETER, AND A SYNCHRO14. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17879740 ↗
• MalfunctionJul 31, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT COULD NOT PASS THROUGH THE CATHETER HUB AND THE PUSHWIRE WAS DAMAGED. IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN COULD NOT ADVANCE THE COIL THROUGH THE CATHETER HUB. MULTIPLE ATTEMPTS WERE MADE TO RESHEATH THE COIL AND INSERT INTO THE CATHETER BUT THE COIL CONTINUED TO GET STUCK AND WAS NOT ABLE TO PASS THROUGH THE HUB. THE PUSHWIRE WAS DAMAGED AT THE DISTAL SEGMENT. THE COIL WAS DISCARDED AND REPLACED. THE REPLACEMENT COIL WAS ABLE TO PASS THROUGH THE CATHETER HUB WITHOUT ISSUE. ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) AND THE PHYSICIAN WAS EXPERIENCED WITH THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER USED IN THE PROCEDURE WAS NOT A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430474 ↗
• MalfunctionSep 28, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND 2 DETACHMENT ATTEMPTS WERE MADE MANUALLY. A SECOND INSTANT DETACHER WAS NOT USED AS THERE WERE NO ISSUES WITH THE INSTANT DETACHER. A REPLACEMENT COIL WAS SUCCESSFULLY DETACHED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A TERUMO LONG SHEATH, NAVIEN GUIDE CATHETER, ECHELON 10 MICROCATHETER, AND STRYKER GUIDEWIRE. MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT TWO DETACHMENT ATTEMPTS WERE MADE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496299 ↗
• MalfunctionSep 9, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND 2 DETACHMENT ATTEMPTS WERE MADE MANUALLY. A SECOND INSTANT DETACHER WAS NOT USED AS THERE WERE NO ISSUES WITH THE INSTANT DETACHER. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A COOK LONG SHEATH, NAVIEN GUIDE CATHETER, ECHELON 10 MICROCATHETER, AND STRYKER GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15388352 ↗
• MalfunctionDec 2, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE TWO COILS COULD NOT BE DETACHED WITH THE SAME INSTANT DETACHER, AND ONE OF THE COILS PREMATURELY DETACHED IN THE CATHETER AFTERWARDS. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY (A-COM). THE MAX DIAMETER WAS 5 MM, AND THE NECK DIAMETER WAS 2.5 MM. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT COIL EMBOLIZATION WAS PERFORMED FOR A SUBARACHNOID HEMORRHAGE (SAH) IN THE A-COM. THE FIRST AXIUM PRIME COIL WAS INSERTED AND COULD NOT BE DETACHED USING THE INSTANT DETACHER. WHEN PULLING THE DELIVERY WIRE AND TRYING TO COLLECT, THE COIL DETACHED WHEN IT RETURNED TO THE INSIDE OF THE CATHETER ABOUT 3 CM, SO THE GUIDEWIRE WAS USED TO PUSH THE COIL INTO THE ANEURYSM SUCCESSFULLY. THE NEXT PRIME HELIX COIL WAS INSERTED AND TRIED TO BE DETACHED WITH THE SAME DETACHER, BUT IT COULD NOT BE DETACHED. THE INSTANT DETACHER WAS REPLACED, AND THERE WAS NO PROBLEM WITH DETACHMENT AFTERWARDS. THEREFORE, TWO COILS WERE ADDED AND FINISHED. THE REMAINING TWO COILS WERE USED WITHOUT ANY PROBLEMS AND THE PROCEDURE WAS COMPLETED. THE DOCTOR HAD ATTEMPTED DETACHMENT 2-3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931374 ↗
• MalfunctionJul 19, 2019Activation Problem; Activation Problem

  MEDTRONIC RECEIVED REPORT THAT DURING THE EMBOLIZATION OF ANEURYSM BY COILS, AXIUM PRIME 3X8 HELICAL COIL WAS DELIVERED. HOWEVER, UPON THE DETACHMENT ATTEMPT (2-3) WITH THE INSTANT DETACHER ID, THE COIL FAILED TO DETACH. THE DETACHMENT ATTEMPT WAS MADE SEVERAL TIMES BUT FAILED. MANUAL DETACHMENT (2-3) WAS ATTEMPTED MULTIPLE TIMES BUT ALSO FAILED. IT WAS THEN DECIDED TO RETRIEVE THE COIL BY PULLING ON THE DELIVERY WIRE. UPON THIS MANEUVER, THE COIL SEPARATED. NO PATIENT INJURY OCCURRED. THIS EVENT OCCURRED DURING THE TREATMENT OF AN ANTERIOR COMMUNICATING ARTERY (ACOM). THE ANEURYSM WAS SACCULAR, WITH A 5MM MAX DIAMETER AND 2.4MM NECK. THE BLOOD FLOW WAS NORMAL, AND THE ANATOMY WAS MODERATE IN TORTUOSITY. THE REPORTED DEVICE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8809231 ↗
• MalfunctionMay 1, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING THE PROCEDURE, THE AXIUM PRIME COIL FAILED TO DETACH. THE PRODUCT WAS TAKEN OUT FROM THE PACKAGE AND THE COIL WAS TAKEN OUT FROM THE SHEATH. AFTER EMBOLIZATION, IT COULD NOT BE DETACHED USING ID-1. THE COIL WAS REMOVED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. THERE WAS ALSO NO PROBLEM WITH MICROCATHETER USED AND ID-1. THERE WAS NO ABNORMALITY ON THE APPEARANCE OF THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY OCCURRED. SIZE OF ANEURYSM: 5 MM. THE PRODUCT TRIED TO BE USED DURING A NORMAL ANEURYSM TREATMENT. AIRWAY BILL NUMBER: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8570335 ↗
• MalfunctionFeb 11, 2019Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF CEREBRAL ANEURYSM, THIS COIL HAD TAIL OUTSIDE THE ANEURYSM. IT WAS REPORTED THAT AFTER FRAMING WITH A COIL OF ANOTHER COMPANY, THE DOCTOR USED THE REPORTED COIL. THE REPORTED COIL WAS INSERTED WITHOUT PROBLEM. THE COIL WAS DETACHED, AND THE DELIVERY PUSHER WAS REMOVED. AFTER A WHILE, THE TAIL OF THE COIL WENT BACK TO THE INSIDE OF THE MICROCATHETER. THE DOCTOR INSERTED THE FOLLOWING COIL IN THAT SITUATION AND PUSHED THE TAIL OF THE REPORTED COIL OUT OF THE MICROCATHETER, AND THE FOLLOWING COIL WAS ALSO INSERTED. IT WAS REPORTED THAT THE PHYSICIAN CONFIRMED THROUGH ANGIOGRAPHY THAT THIS COIL DETACHED. THE PUSHWIRE WAS COMPLETELY REMOVED FROM THE CATHETER. THERE WAS NOT ANY COIL STILL ATTACHED TO THE PUSHWIRE. THE DEVICES WERE PREPARE PER IFU. THE COIL WAS DETACHED AND PLACED INSIDE THE PATIENT (NO COMPLICATIONS OCCURRED). REOPERATION WAS NOT REQUIRED. THE SURGICAL TIME WAS NOT EXTENDED. NO PATIENT INJURY WAS REPORTED. VESSEL DIAMETER: MEDIUM VESSEL STATUS: NO ABNORMALITIES. INSTANT DETACHER LOT NUMBER A687510.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8326540 ↗