AxiumTM APB-5-20-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536008236), received between Mar 11, 2020 and Jun 20, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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.

• MalfunctionJun 20, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM TREATMENT, WHILE PREPARING TO USE THE PRODUCT AND PUSHING THE AXIUM COIL OUT INTO THE BATH, IT WAS NOTICED THAT IT HAD DETACHED AND EARLY DISLODGEMENT, AND THEREFORE IT WAS NOT USED. IT WAS NOTED THAT THERE WAS NO DEFORMATION OR DAMAGE OBSERVED IN THE DELIVERY PUSHER. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY. THE COIL WAS NOT REPOSITIONED, AND NO DISLODGEMENT WAS ATTEMPTED. ADDITIONALLY, THE DELIVERY PUSHER DID NOT ROTATE INSIDE THE PATIENT'S BODY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302172 ↗
• MalfunctionJan 21, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT WAS RESOLVED BY REPLACING WITH ANOTHER COIL WHICH WAS PERFORMED ON (B)(6) 2025. THERE WAS NO ISSUE WITH THE CATHETER USED. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196215 ↗
• MalfunctionNov 27, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798267 ↗
• InjuryJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECIEVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY. PHYSICIAN PERFORMING THE CASE AND DURING REPOSITION AXIUM COIL FOR FILLING THERE WAS AUTO DETACHED, AND COILS MOVE TO PARENT ARTERY. THEN PHYSICIAN DECIDED TO USE SPIDERFX TO REMOVE THE COIL. THE PUSHWIRE WAS NOT BENT OR BRKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELVIERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM IN THE VERTEBRAL ARTERY. THE MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 3MM. PATIENT BLOOD FLOW AND VESSEL TORTUSOITY WAS NORMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18433211 ↗
• InjuryJun 1, 2023Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL PROTRUDED AND INADVERTENTLY STOPPED DURING PLACEMENT WITHIN THE ANEURYSM. CAUSED INTERRUPTION OF THE PROCEDURE AND CONSEQUENTLY IMPOSSIBILITY OF MECHANICAL TREATMENT OF THE VASOSPASM, INVOLVING A HIGHER RISK OF LATE ISCHEMIA.

  Patient problems: Vasoconstriction

  MAUDE report 17039960 ↗
• MalfunctionAug 10, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 7.36MM, AND THE NECK DIAMETER WAS 4.57MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE COILS WERE PLACED IN THE ANEURYSM. WHEN THE COIL MARKER ON THE PUSHER MARKER AND MICROCATHETER WERE ALIGNED, THE COIL WAS ATTEMPTED TO BE DETACHED VIA THE HYPOTUBE. WHEN THIS WAS DONE, THE RELEASE ELEMENT WAS ALSO BROKEN AND COULD NOT BE SEPARATED. NO DETACHMENT ATTEMPTS HAD BEEN MADE WITH THE INSTANT DETACHER, AND ONE MANUAL DETACHMENT ATTEMPT WAS MADE. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A 6FR SHEATH, 6FR ENVOY GUIDE CATHETER, HEADWAY 17 MICROCATHETER, AND TRANSFORM 4X10 BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202262 ↗
• MalfunctionNov 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ANEURYSM SIZE WAS 11.9 X 7 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800672 ↗
• MalfunctionMar 11, 2020Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE MICROCATHETER AND BECAME STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, RIGHT POSTERIOR COMMUNICATING (PCOM) ANEURYSM WITH A MAX DIAMETER OF 7MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL EXPERIENCED RESISTANCE DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL THREE TIMES DURING THE PROCEDURE, BUT THE COIL WAS EVENTUALLY REMOVED FROM THE MICROCATHETER AND IT WAS NOTICED THE COIL WAS STRETCHED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE AN ENVOY DAXB GUIDE CATHETER AND SL-10 MICROCATHETER. THE RESISTANCE WAS FELT IN NEAR THE HUB OF THE MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9821831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab