Axium PrimeTM APB-5-20-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536032354), received between Dec 29, 2020 and Apr 18, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY AND ANOTHER HAD RESISTANCE IN THE DISTAL SECTION OF AN ECHELON MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE LEFT OPHTHALMIC ARTERY. THE MAX DIAMETER WAS 5.3MM X 6.5MM. THE NECK DIAMETER WAS 2.6MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL IS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 6.5MM. THE TREATMENT WAS STENT-ASSISTED COIL EMBOLIZATION IN THE TREATMENT OF INTRACRANIAL ANEURYSM. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DURING THE DELIVERY PROCESS THE COIL WAS ACCIDENTALLY DRAWN WIRE BEFORE THE COIL WAS DETACHED, AND IT WAS TAKEN OUT THROUGH THE MICROCATHETER. IT DETACHED ACCIDENTALLY WITH WIRE DRAWING. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED. THE NEXT COIL WAS DELIVERED DURING THE SURGERY, THE COIL COULD NOT BE PUSHED OUT AFTER REACHING THE DISTAL OF THE MICROCATHETER. THE QUALITY OF THE COIL AND THE MICROCATHETER WAS SUSPECTED. NO SYMPTOMS WERE REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139243 ↗
• MalfunctionSep 13, 2021Stretched; Unintended Movement; Stretched; Unintended Movement

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS WILL BE SUBMITTED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465728 ↗
• MalfunctionAug 26, 2021Stretched; Unintended Movement; Stretched; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT STRETCHED WITH A SEGMENT EXTENDING INTO THE PARENT VESSEL. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 2MM. BLOOR FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL (MODEL: APB-5-20-HX-SS, LOT: B165311) WAS THE THIRD TO BE IMPLANTED DURING THE PROCEDURE. AFTER ENTERING THE ANEURYSM, PART OF THE AXIUM COIL STRETCHED WITH A SEGMENT EXTENDING INTO THE PARENT VESSEL AND COULD NOT BE WITHDRAWN. THE PROCEDURE WAS HALTED. THE PUSHER WAS WITHDRAWN AFTER CUTTING THE WIRE IN VITRO. A REBAR CATHETER WAS USED TO DEPLOY A SOLITAIRE AB (SAB) STENT TO HOLD THE COIL IN PLACE. TWO ADDITIONAL COILS WERE SUBSEQUENTLY PLACED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR OTHER COMPLICATIONS ASSOCIATE WITH THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12372595 ↗
• MalfunctionDec 29, 2020Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT ONCE THE ANCILLARY DEVICES WERE IN PLACE, THREE COILS WERE DELIVERED: APB-5-20-HX-SS, APB-6-15-3D-SS, QC-7-30-3D IN SEQUENCE. WHEN PUSHING THE APB-5-20-HX-SS, THE PUSHWIRE KINKED/BROKE IN THE DISTAL SEGMENT. THERE WAS NO FRICTION DURING DELIVERY NOTED, AND A CONTINUOUS FLUSH HAD BEEN USED. A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE SMOOTHLY. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE RIGHT POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 10 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN INDICATED THAT THE PUSHWIRE WAS BROKEN INTO TWO PIECES, WHICH WERE TAKEN OUT BY SUCTION AND THE MICROCATHETER. IT IS UNKNOWN IF THERE WERE ANY OTHER ISSUES THAT RESULTED IN THE DAMAGE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11091140 ↗

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