AxiumTM APB-1-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536021136), received between Sep 24, 2020 and May 13, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. REGARDING THE AXIUM COIL (MODEL: APB-3-4-3D-ES, LOT: 226656023), THERE WAS NO FRICTION/RESISTANCE OR OTHER DIFFICULTY DURING DELIVERY OR POSITIONING OF THE COIL. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. REGARDING THE AXIUM COIL (MODEL: APB-1-4-3D-ES, LOT: 224302031), 2 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298353 ↗
• MalfunctionMar 12, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL GOT STUCK IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED ANEURYSM IN THE LEFT ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 2 MM AND A 1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL GOT STUCK IN THE MICROCATHETER AND COULD NOT BE DELIVERED TO THE ANEURYSM. 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. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE COIL RESISTANCE WAS NOT DETERMINED. THE RESISTANCE WAS LOCATED IN THE DISTAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS KINK, DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887206 ↗
• MalfunctionSep 20, 2023Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING PREPARATION, A KINK ON HAND WAS CONFIRMED DURING DELIVERY TO THE MICROCATHETER. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE LOCATION OF THE DAMAGE IS THE PROXIMAL PUSHER. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE KINK WAS DISCOVERED DURING THE PROCEDURE. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE SECURED IN THE GUIDEWIRE WHEN THE PACKAGE WAS OPENED. THERE WERE NO DEFINITE PROBLEMS THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782089 ↗
• MalfunctionSep 18, 2023Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769979 ↗
• MalfunctionNov 16, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD RESISTANCE IN THE SHEATH. INDUCTION WAS ATTEMPTED WITH THE CORRESPONDING PRODUCT FROM SL-10 DURING PREOPERATIVE EMBOLIZATION OF A CRANIOTOMY OF A MENINGIOMA BUT RESISTANCE WAS FELT SO IT WAS REMOVED. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR AN MENINGIOMA. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806659 ↗
• MalfunctionJun 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THE INSTANT DETACHER WAS USED ON THE COIL. ONE OF THE COILS WAS PREMATURELY RELEASED INTO THE MICROCATHETER, AND IT WAS NECESSARY TO REMOVE IT AND PUSH THE COIL WITH A MICROGUIDE. THE OTHER COIL WAS DETACHED INSIDE THE ANEURYSM, BUT WHEN IT WAS REMOVED OR PUSHED FROM IT, IT CAME WITH IT. WHEN AN ATTEMPT WAS MADE TO REPOSITION THE COIL, IT DETACHED IT EARLY. THERE WAS NO TWIST OR SIGN OF DAMAGE ON THE PUSHWIRE, AND THE COIL WAS IMPLANTED IN THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040153 ↗
• MalfunctionMay 11, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO ISSUES ENCOUNTERED PRIOR TO NON-DETACHMENT OF THE COIL. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE AFTER REMOVAL, AND A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEMS. ANEURYSM CH ARACTERISTICS, VESSEL TORTUOSITY, AND INSTRUCTIONS FOR USE (IFU) PREPARATION, AND WHETHER AN INSTANT DETACHER WAS USED WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805531 ↗
• MalfunctionFeb 18, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE MANUAL DETACHMENT WAS MADE, AND THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342701 ↗
• MalfunctionSep 24, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THERE WAS NO KINK OR DAMAGE OBSERVED TO THE PUSHWIRE. THE PATIENT WAS BEING TREATED FOR A 1-2MM ANEURYSM OF AN OPHTHALMIC ARTERY. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR HARM RELATED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10578368 ↗