Axium PrimeTM APB-2-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536031890), received between Apr 20, 2020 and Feb 19, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) BIFURCATION WITH A MAX DIAMETER OF 3.8 MM AND A 2.1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE COILING PROCEDURE APB-2-4-3D-ES COULDN'T BE DETACHED. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2 TIMES. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. 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 18731300 ↗
• MalfunctionApr 17, 2023Separation Failure; Separation Failure

  2ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO EVENTS/ISSUES ENCOUNTERED PRIOR TO COIL NON-DETACHMENT. IT WAS UNKNOWN IF THERE WAS ANY PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755953 ↗
• MalfunctionJan 10, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED, AND THE PUSHWIRE WAS BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. NO SURGICAL OR MEDICAL INTERVENTION WAS NEEDED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED ANEURYSM. ANCILLARY DEVICES INCLUDE A 6F NAVIEN GUIDE CATHETER, SL-10 MICROCATHETER, AND CHIKAI 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206380 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS NOT IMPLANTED AFTER PREMATURE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312732 ↗
• MalfunctionSep 18, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE ONE COIL WOULD NOT DETACH, AND ANOTHER COIL WAS STUCK IN THE SHEATH. IT WAS REPORTED THAT AFTER THE MICROCATHETER WAS IN PLACE A APB-2-4-3D-ES COIL WAS USED FOR FILLING, BUT THE COIL COULDN¿T BE DEPLOY ED. FOR ¿SPARE DEPLOYMENT¿ IT STILL COULDN¿T BE DEPLOYED. THE COIL WAS WITHDRAWN, AND ANOTHER COIL WAS USED TO COMPLETE THE FILLING. FINALLY, THE SURGEON CHOSE APB-1.5-4-3D-ES FOR ENDING COILING. THIS COIL COULD NOT BE PUSHED OUT OF THE PROTECTIVE SHEATH. AFTER MANY ATTEMPTS, IT STILL COULD NOT BE PUSHED OUT. AFTER CHANGING TO ANOTHER APB-1.5-2-3D-ES, THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 4 MM. THE NECK DIAMETER WAS 2 MM. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

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

  MAUDE report 10553792 ↗
• MalfunctionAug 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ROUTINE ANTERIOR AND POSTERIOR CIRCULATION ANTEROLATERAL ANGIOGRAPHY CONFIRMED THAT THE ANEURYSM WAS AT THE BIFURCATION OF THE LEFT BRAIN THAT HAD RUPTURED AND HAD HEMATOMA. THE MICROCATHETER WAS ADVANCED TO THE ANEURYSM, AND THE PHYSICIAN STARTED OPERATING THE COILS. THE LAST 2- 4 COILS WERE RELEASED, AND 2-4 COILS WERE SUCCESSFULLY TAKEN OUT OF THE BODY WITH A SELF-MADE SNARE. THERE WAS NO ADDITIONAL INJURY TO THE PATIENT. POSTOPERATIVE ANTERIOR AND LATERAL ANGIOGRAPHY AND 3D RECONSTRUCTION WERE TAKEN, AND THE SURGEON ENDED THE OPERATION. A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. ANCILLARY DEVICES INCLUDED AN ECHELON 10 CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10356807 ↗
• MalfunctionMay 20, 2020Deformation Due to Compressive Stress; Detachment of Device or Device Component; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE IN THE ECHELON CATHETER AND BECAME STRETCHED. THE PATIENT WAS BEING TREATED FOR AND UNRUPTURED SACCULAR ANEURYSM OF AN OPHTHALMIC ARTERY SEGMENT. THE ANEURYSM MAX DIAMETER WAS 2MM AND THE NECK DIAMETER WAS 2.2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE. THE COIL WAS ADVANCED THROUGH THE CATHETER. WHEN DELIVERING THE COIL, THE PROXIMAL END OF THE COIL HAD RESISTANCE IN THE DISTAL END OF THE CATHETER. THE COIL WAS THEN RECOVERED AND REMOVED. WHEN THE COIL WAS REMOVED, IT WAS OBSERVED THAT THE PUSHWIRE HAD BROKEN. THE ENTIRE SYSTEM WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPRESENTATIVE REPORTING THAT THE COIL WAS NOT SMOOTH COMING ON OUT OF THE INTRODUCER SHEATH. IT WAS CLARIFIED THAT THE COIL HAD DETACHED PREMATURELY WITHIN THE CATHETER AND THERE WAS DAMAGE TO THE COIL OBSERVED AFTER REMOVAL FROM THE CATHETER. THERE WAS NO DAMAGE OF THE CATHETER OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10074459 ↗
• MalfunctionApr 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM PRIME COIL THAT RELEASED PREMATURELY DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT ANTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 3.2MM WITH A NECK DIAMETER OF 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE ECHELON-10 MICROCATHETER WAS IN PLACE AND THE FIRST COIL WAS PLACED SUCCESSFULLY. THE SECOND COIL WAS SELECTED FOR EMBOLIZATION BUT WAS NOT SHAPED IDEALLY. THE MICROCATHETER AND AXIUM COIL WERE WITHDRAWN TOGETHER IN ORDER TO RESHAPE THE MICROCATHETER. WHEN THE AXIUM SPRING COIL WAS PUSHED OUT, IT WAS OBSERVED THAT IT HAD ALREADY BEEN RELEASED AND COULD NOT BE USED. THE MICROCATHETER WAS THEN RESHAPED AND PLACED AND THE REMAINING COILS WERE USED NORMALLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9978426 ↗