AxiumTM APB-1-3-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536020924), received between Dec 13, 2018 and Jan 9, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJan 9, 2026Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WIRE INSIDE THE HOOP WAS FOUND TO BE BROKEN AT THE TIME OF OPENING. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028080 ↗
• MalfunctionApr 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PACKAGE WAS OPENED, THE SPRING COIL WAS TAKEN OUT, AND INSERTED IT INTO THE MICROCATHETER, BUT FOUND THAT IT WAS DIFFICULT TO OPERATE AND IT COULD NOT BE PUSHED. 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, RUPTURED LEFT MIDDLE CEREBRAL ARTERY ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE PROXIMAL END OF THE CATHETER. THE COIL DID NOT COME OUT OF THE IN TRODUCER SHEATH SMOOTHLY. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE OBSERVED TO THE COIL OR CATHETER ATER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883708 ↗
• MalfunctionApr 10, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE LEFT MIDDLE CEREBRAL ARTERY BIFURCATION WITH A MAX DIAMETER OF 6MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE SPRING COIL COULD NOT BE DETACHED, AND THE DETACHER AND MANUAL  DETACHMENT WERE TRIED MANY TIMES, AND THEN WITHDRAWN FROM THE BODY. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES AND TRIED WITH A SECOND DETACHER 2 TIMES. THERE WERE 2 ATTEMPTS OF MANUAL DETACHMENT VIA HYPOTUBE. IT WAS NOTED THAT THERE WAS NO ISSUES WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079113 ↗
• MalfunctionJan 11, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT "UNLABELED" IS A PHENOMENON IN WHICH THE WIRES OF THE COIL DID COME OUT. THE ISSUES THAT RESULTED IN THE DAMAGE WERE BECAUSE THE INTRODUCER SHEATH WAS NOT DELIVERED ALL THE WAY IN THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498813 ↗
• MalfunctionMar 24, 2023Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED NO INTERVENTION HAS BEEN TAKEN. THE PATIENT CONTINUES TO HAVE NUMBNESS IN HER RIGHT LEG AND MILD WEAKNESS. NO MEDICAL INTERVENTION WAS OFFERED AT THE DISCRETION OF THE INITIAL PHYSICIAN.

  Patient problems: Muscle Weakness/Atrophy; Numbness

  MAUDE report 16615083 ↗
• MalfunctionDec 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN ATTEMPT WAS MADE TO VISUALLY INSPECT THE COIL IN SALINE SOLUTION DURING COIL PREPARATION. AT THAT TIME, IT DID NOT COME OUT OF THE INSERTER. THE PHYSICIAN DETERMINED THAT IT WAS DEFECTIVE AND NO LONGER BE USED BECAUSE A STRANGE RESISTANCE WAS FELT. COIL RESISTANCE/STUCK IN SHEATH OCCURRED. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND THERE WAS NO ANOMALY WITH VESSEL TORTUOSITY. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING PREPARATION, THE COIL WAS TRIED TO BE PUSHED OUT IN WATER AND VISUALLY TO BE CHECKED. THE INTRODUCER SHEATH WAS VERTICALLY HELD WHEN IT WAS PUSHED OUT. THE DELIVERY WIRE WAS PUSHED, BUT THE COIL DID NOT COME OUT FROM THE TIP, SO IT WAS NOT PULLED BACK IN WATER AND STOPPED TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16033805 ↗
• MalfunctionJun 3, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO PARTICULAR DAMAGE TO THE COIL PUSHWIRE. THE COIL WAS IMPLANTED AND SUFFICIENTLY SECURED THOUGH IT COULD NOT BE CONFIRMED IF THE COIL WAS IMPLANTED AS ORIGINALLY INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930626 ↗
• MalfunctionDec 13, 2018Break; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Break; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AS THE PHYSICIAN WAS DEPLOYING THE COIL THROUGH THE MICROCATHETER, RESISTANCE WAS FELT CAUSING THE MICROCATHETER TO BOW INTO THE VERTEBRAL ARTERY. WHEN THE DOCTOR TRIED TO RELEASE TENSION TO ALLEVIATE THIS THEY NOTICED THAT THE COIL HAD SEPARATED, SO THEY USED THE COIL TO DEPLOY THE COIL IN THE DISTAL END INTO THE TARGET ARTERY. IT WAS NOTED THAT A SMALL FRACTION OF THE COIL JUST DISTAL TO THE DETACHMENT AREA WAS STILL ATTACHED TO THE BALL AND PIN. THERE WERE NO RELATED PATIENT SYMPTOMS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FISTULA/AVM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161699 ↗