Axium PrimeTM APB-3-6-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536031937), received between Dec 9, 2020 and Jul 31, 2023 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE AND WAS DAMAGED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ANEURYSM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER THE COIL STARTED ADVANCING THROUGH THE ECHELON MICROCATHETER, RESISTANCE OCCURRED IN THE MIDDLE OF THE CATHETER AND THE COIL COULD NOT BE FULLY PUSHED OUT. THE COIL WAS WITHDRAWN AND THE TIP WAS FOUND STRETCHED. IT WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17426068 ↗
• MalfunctionApr 27, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE ECHELON MICROCATHETER WAS FOUND TO BE DAMAGED AFTER IT WAS SHAPED. THE CATHETER WAS REPLACED TO FILL THE ANEURYSM. IT WAS THEN FOUND THAT THE COIL PUSH ROD WAS BROKEN. THE COIL WAS REPLACED, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5*8MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14221158 ↗
• MalfunctionDec 10, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS RESISTANCE WITH THE AXIUM COIL IN BOTH THE INTRODUCER SHEATH AND THE CATHETER. THERE WAS RESISTANCE PUSHING THE COIL OUT OF THE SHEATH BUT IT WAS ABLE TO BE PUSHED OUT. RESISTANCE WAS THEN ALSO FELT IN THE ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976259 ↗
• MalfunctionDec 1, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED DURING PROCEDURE, NO PATIENT INVOLVED BECAUSE NOT DETACHED COIL. AND UNDETACHED AXIUM WHILE SYSTEM FULL BACK AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910345 ↗
• MalfunctionMay 21, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED ANEURYSM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE COIL REACHED THE LESION, THE DOCTOR TRIED TO DETACH THE COIL BUT IT DIDN'T DETACH. THE DOCTOR HAD TRIED TO DETACH WITH THE INSTANT DETACHER APPROXIMATELY 10 TIMES. A SECOND INSTANT DETACHER WAS USED THE SAME AMOUNT OF TIMES. MANUAL DETACHMENT WAS ATTEMPTED WITH THE HYPOTUBE APPROXIMATELY 10 TIMES, BUT THE COIL STILL COULD NOT BE DETACHED. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863754 ↗
• MalfunctionMar 30, 2021Break; Stretched; Material Deformation; Physical Resistance/Sticking; Break; Stretched; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL PUSHWIRE WAS ONLY BENT BUT DID NOT BREAK. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588400 ↗
• MalfunctionJan 26, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES PRIOR TO THE COIL NON-DETACHMENT, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL. THERE WAS NO ISSUE OR DAMAGE TO THE COIL OR CATHETER MARKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229178 ↗
• MalfunctionDec 9, 2020Difficult or Delayed Positioning; Separation Failure; Detachment of Device or Device Component; Unintended Movement; Physical Resistance/Sticking; Difficult or Delayed Positioning; Separation Failure; Detachment of Device or Device Component; Unintended Movement; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978909 ↗