Axium PrimeTM APB-1-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536031838), received between Nov 24, 2021 and May 8, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE FORMAL PROCESS OF HYDRATION AND EQUIPMENT PREPARATION WERE PERFORMED, IT WAS FOUND THAT THE COIL WAS DETACHED IN THE MICROCATHETER IN ADVANCE DURING DELIVERY. IN ORDER TO ENSURE THE SAFETY OF THE SURGERY, THE MICROCATHETER WAS WITHDRAWN FROM THE BODY, AND THE COIL WAS PUSHED OUT OF THE MICROCATHETER. THEN RE-PUSHED THE MICROCATHETER TO GO UPPER TO DELIVER A NEW COIL, AND THEN THE SURGERY WAS COMPLETED SMOOTHLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 4X3MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OFTHIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885313 ↗
• MalfunctionJan 4, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING AN AXIUM COIL UNABLE TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT 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 SPRING COIL COULDN'T BE FULLY DETACHED. 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 16094657 ↗
• MalfunctionJan 4, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. THE AXIUM COIL WAS REPLACED WITH ANOTHER AXIUM COIL, WHICH LED TO THE SECOND COIL NOT DETACHING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 5*3MM AND A 2MM NECK DIAMETER. 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 13152868 ↗
• MalfunctionDec 23, 2021Detachment 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 COIL EXPERIENCED RESISTANCE IN THE MIDDLE OF THE ECHELON 10 MICROCATHETER AND THE PUSH WIRE WAS LATER FOUND TO BE STRETCHED AND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR CEREBRAL ARTERY BIFURCATION. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3.35MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT COIL HAD GREAT RESISTANCE AFTER ENTERING THE ECHELON 10 MICROCATHETER. AFTER THE SPRING COIL WAS PUSHED OUT OF ONE SIDE OF THE CATHETER, WHEN ADJUSTING THE POSITION OF THE SPRING COIL, IT WAS FOUND THAT THE SPRING COIL COULD NOT BE WITHDRAWN INTO THE MICROCATHETER. THE EXPERT CHOSE TO WITHDRAW THE MICROCATHETER AND THE COIL AS A WHOLE. AFTER THE WITHDRAWAL, THE COIL WAS PUSHED OUT AND FOUND THAT THE COIL WAS SEPARATED FROM THE PUSH WIRE AND THE DISTAL PUSH WIRE WAS STRETCHED. A CONTINUOUS FLUSH WAS ADMINISTERED. THE PHYSICIAN HAD REPOSITIONED THE DEVICE ONCE. 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 13078227 ↗
• MalfunctionNov 24, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT MIDDLE CEREBRAL ARTERY. THE MAX DIAMETER WAS 2MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT COIL COULD NOT BE PUSHED INTO THE MICROCATHETER WAS STUCK IN THE Y VALVE. 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). 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 12872772 ↗