AxiumTM APB-2-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536020986), received between May 15, 2019 and Oct 31, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY. THE COIL BECAME PRE-DETACHABLE IN THE MICROCATHETER. REMOVED AND TREATED WITH ANOTHER COIL. THE COIL WAS REMOVED FROM THE PATIENT BY WITHDRAWING THE CATHETER, NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL .THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE A COM LOCATION. THE MIX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 1.5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: FUBUKI 8F GUIDE CATHETER, HEADWAY17 MICROCATHETER, SYNCHRO14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705505 ↗
• MalfunctionAug 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, THE AXIUM COIL DETACHED PREMATURELY. THE PHYSICIAN HAD NOT ATTEMPTED TO DETACH THE COIL. IT WAS NOTED THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR OTHER DIFFICULTY OBSERVED DURING DELIVERY BUT THE PHYSICIAN DID TRY 2-3 TIMES TO REPOSITION THE COIL. THE PHYSICIAN DID NOT ROTATE THE PUSHER DURING THE PROCEDURE. THE PUSHWIRE WAS NOT BENT OR BROKEN. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED. THE COIL WAS REMOVED AND REPLACED WITH A COMPETITOR'S DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATE WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377594 ↗
• MalfunctionJul 9, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM PRIME COIL FAILED TO DETACH. THREE DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. A SECOND DETACHER WAS NOT USED. THE HYPOTUBE WAS BROKEN 2 TIMES. THE DETACHER WAS DISCARDED AT THE SITE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). IT IS UNKNOWN IF THE PATIENT WAS INFECTED WITH A COMMUNICABLE DISEASE. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THERE ARE NO IMAGES. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT ANTERIOR COMMUNICATING ARTERY, UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 8 MM AND THE NECK WAS 4 MM. THE BLOOD FLOW IS UNKNOWN. THE VESSEL ANATOMY WAS NORMAL. THE CUSTOMER WAS NOTIFIED TO RETURN THE DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10255330 ↗
• InjuryDec 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF AXIUM PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM IN THE ANTERIOR COMMUNICATING (ACOM) ARTERY. VESSEL TORTUOSITY WAS DESCRIBED AS MODERATE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL WAS ADVANCED WITHOUT DIFFICULTY. THE COIL REPORTEDLY PREMATURELY DETACHED LEAVING THE COIL PARTIALLY OUTSIDE THE ANEURYSM. THERE HAD BEEN NO ATTEMPTS TO DETACH THE COIL AND THE DELIVERY WIRE HAD NOT BEEN ROTATED. AFTER PREMATURE DETACHMENT, A STENT WAS USED TO PIN DOWN THE COIL EXTENDING OUT OF THE ANEURYSM. THERE WERE NO REPORTS OF PATIENT SYMPTOMS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9512032 ↗
• MalfunctionNov 22, 2019Separation Failure; Detachment of Device or Device Component; Activation Problem; Separation Failure; Detachment of Device or Device Component; Activation Problem

  MEDTRONIC RECEIVED REPORT OF THE AXIUM COIL FAILED TO DETACH WITH THE INSTANT DETACHER AND VIA THE MANUAL DETACHMENT. THE COIL EVENTUALLY DETACHED VIA MANIPULATION. NO PATIENT INJURY OCCURRED. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT IC-PC, UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 4.5MM AND THE NECK WAS 3.5MM. THE BLOOD FLOW AND THE VESSEL ANATOMY WERE BOTH NORMAL. VIA 9FOPTIMO, HEADWAY 17 AND ECHELON 10 WERE USED RESPECTIVELY TO APPROACH THE TWO TACTICS TO THE TARGET IC-PC 4.5MM ANEURYSM USING DOUBLE CATHETER TECHNIQUE. THE TIP OF THE ECHELON10 WAS SET NEAR THE NECK OF THE ANEURYSM AND THE TIP OF THE HEADWAY 17 WAS SET AT THE DOME PART, AND COIL EMBOLIZATION WAS STARTED FROM THE ECHELON. THE FIRST PRIMEFRAME4 * 12 WAS POSITIONED, AND THEN 6 AXUIMPRIMES WERE USED. APPROXIMATELY HALF THE REPORTED COIL AXUIMPRIMEHELIX2 * 2 WHICH WAS USED AS THE LAST ONE WAS DELIVERED IN THE ANEURYSM, AND THE STENT WAS PLACED BEFORE DETACHMENT SO THAT THE WHOLE COIL DID NOT COME OUT. THE STATUS OF COIL WAS KEPT TEMPORARILY WITHOUT BEING DETACHED, AND FIRSTLY, ECHELON 10 WAS REMOVED, AND XT17 WAS DELIVERED TO THE DISTAL PART OF THE ANEURYSM AND IC-TOP, ATLAS 4.5 * 21WAS DEPLOYED WI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9363774 ↗
• MalfunctionMay 15, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM COIL (APB-2-2-HX-ES) HAD RESISTANCE IN THE MICROCATHETER AND THEN PREMATURELY DETACHED INSIDE THE MICROCATHETER. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612998 ↗