AxiumTM APB-1.5-3-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536021150), received between Jul 23, 2019 and May 28, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Unintended Movement; Migration; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Unintended Movement; Migration

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. DUE TO PREMATURE DETACHMENT, DETACHMENT WAS NOT ATTEMPTED. THE COIL WAS IMPLANTED, BUT NOT IN THE INTENDED LOCATION. THE PROCEDURE WAS COMPLETED WITH 1~2 CM PROTRUDING FROM THE ANEURYSM (A.COM) WITHOUT FITTING INTO THE ANEURYSM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099371 ↗
• MalfunctionJul 10, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PRIOR TO COIL NON-DETACHMENT NO OTHER PARTICULAR ISSUES HAD OCCURRED. NO OBVIOUS PUSHWIRE DAMAGE WAS OBSERVED AFTER THE COIL WAS REMOVED FROM THE PATIENT. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710273 ↗
• MalfunctionSep 6, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT BEFORE DETACHMENT, IT WAS STOPPED. IT WAS NOTED THAT THE COIL WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695273 ↗
• MalfunctionMar 24, 2023Migration; Migration

  MEDTRONIC RECEIVED INFORMATION THAT THREE AXIUM COILS MIGRATED AFTER DEPLOYMENT. ON MARCH 6TH A PATIENT WAS TREATED FOR A SMALL 2.5MM RUPTURED ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM THAT WAS AT THE A1 , A2 JUNCTION. THE ANEURYSM WAS SACCULAR IN SHAPE. THE HEALTHCARE PROVIDER (HCP) COMPLETED THE PROCEDURE ON MARCH 6TH WITH AN INTRAVASCULAR COILING WITH FEMORAL ACCESS. HE INSERTED 3 COIL (FIRST THE 2-4-3D, SECOND THE 1.5-3-3D, THIRD 1-3-HX). THE CASE WENT AS HOPED. THE PATIENT IN THE FOLLOW UP THE NEXT DAY WAS DOING VERY WELL AND BOTH THE A1 AND A2 WERE OPEN DURING THE FOLLOW UP CT SCAN. PATIENT CONTINUED TO PROGRESS WELL AND WAS NEARLY GOING TO BE DISCHARGED. ON MARCH 21ST THE PATIENT BEGAN HAVING SOME NUMBNESS IN HER RIGHT LEG AND MILD WEAKNESS. THIS WAS REPORTED TO ANOTHER HCP. SHE COMPLETED ANOTHER CT SCAN AND FOUND THAT THERE WAS NOW ARTIFACT FROM THE COIL IN THE A2. SHE REPORTED THAT SHE BELIEVES ONE OF THE COILS HAS MIGRATED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCUALR ANEURSYM IN THE ACOM. THE MAX DIAMETER WAS 2.5MM. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WAS NORM AL. PATIENT INJUR

  Patient problems: Muscle Weakness/Atrophy; Numbness

  MAUDE report 16614967 ↗
• MalfunctionNov 17, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO DAMAGE TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821941 ↗
• MalfunctionJan 12, 2022Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE AND WAS STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR LEFT MIDDLE CEREBRAL ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3.2MM AND THE NECK DIAMETER WAS 2.1MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS SELECTED AS THE LAST COIL FOR THE PROCEDURE. THE COIL HAD RESISTANCE DURING DELIVERY AND WAS FOUND TO BE STRETCHED AND COULD NOT BE IMPLANTED NORMALLY. IT WAS NOTED THAT THE CATHETER WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE COIL WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED CLARIFICATION THAT THERE WAS NO RESISTANCE FELT DURING DELIVERY OF THE COIL IN THE ECHELON 10 MICROCATHETER AND THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE STRETCH WAS OBSERVED DURING THE FILLING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239671 ↗
• MalfunctionDec 14, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT. THERE WERE NO EFFECTS ON THE PATIENT AND THERE WERE NO DISCOMFORT OR PROBLEMS ASSOCIATED WITH THE PUSH WIRE ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002994 ↗
• MalfunctionJan 20, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT TWO DETACHMENT ATTEMPTS HAD BEEN MADE WITH THE INSTANT DETACHER, AND TWO ATTEMPTS HAD BEEN MADE WITH THE MANUAL METHOD. THE SAME INSTANT DETACHER WAS USED NORMALLY TO DETACH OTHER COILS. PRIOR TO THE NON-DETACHMENT NO ISSUES HAD BEEN ENCOUNTERED, AND NO DAMAGE TO THE PUSHWIRE HAD BEEN OBSERVED. THE OTHER COIL THAT WAS STRETCHED HAD BEEN FOUND DURING PREPARATION, AND THERE WERE NO ISSUES THAT MAY HAVE CAUSED THE DAMAGE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202084 ↗
• MalfunctionJul 23, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM PRIME COIL WAS PLACED IN THE ANEURYSM. THE COIL WAS ATTEMPTED TO BE DETACHED TWO TIMES WITH THE INSTANT DETACHER. THEN THE HB METHOD (MANUAL DETACHMENT) WAS ATTEMPTED. HOWEVER, THE COIL STILL DIDN¿T DETACH. THE COIL WAS THEN REMOVED FROM THE PATIENT WITHOUT INCIDENT. A SECOND DETACHER WAS NOT USED. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF AN UNRUPTURED, SACCULAR, ANTERIOR COMMUNICATING (ACOM) ANEURYSM. THE MAX DIAMETER WAS 5 MM AND THE NECK WAS 3MM. THE BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8817395 ↗