Axium PrimeTM APB-4-8-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536031999), received between Nov 19, 2020 and Jun 17, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Break; Unintended Movement; Break; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS DIFFICULT TO DETACH BY MANUAL METHOD. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR OPHTHALMIC ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.17MM AND THE NECK DIAMETER WAS 2.8MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERED AND MANUAL DETACHMENT WAS ATTEMPTED BUT FOUND TO BE DIFFICULT. THREE ATTEMPTS WERE MADE AND THE SURGEON HAD TO REPEATED PUSH AND PULL THE PUSHER; FINALLY THE COIL DETACHED. NO ATTEMPT WAS MADE TO DETACH THE COIL WITH AN INSTANT DETACHER (ID). AFTER THE DETACHMENT, A PORTION OF THE COIL WAS STILL OUTSIDE THE ANEURYSM CAVITY. THE SURGEON USED THE PUSHER TO PUSH THE COIL INTO THE ANEURYSM AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM OR INJURY TO THE PATIENT.

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

  MAUDE report 14733888 ↗
• MalfunctionApr 4, 2022Break; Unintended Movement; Break; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 2.56MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS NO RESISTANCE IN THE DELIVERY PROCESS. WHEN THE FIRST COIL AT THE HALF OF FORMING A HOOP, IT WAS FOUND THAT THERE WAS A LOOP HERNIATION OF THE COIL INTO THE PARENT ARTERY. THEY RECOVERED THE COIL TO ADJUST AND PREPARED TO FORM A HOOP AGAIN, BUT IT WAS FOUND THAT THE OPERATION OF PUSHING THE GUIDE WIRE AND THE COIL BODY WERE NOT SYNCHRONIZED. THEY WITHDREW THE PUSH WIRE AGAIN, AND IT WAS FOUND THAT THE COIL BODY WAS BROKEN. THEY QUICKLY WITHDREW THE MICROCATHETER AND REINSTALLED A NEW GUIDE WIRE AND MICROCATHETER. THEY PUT THE BROKEN PART OF THE COIL INTO THE INSIDE OF THE ANEURYSM AND CONTINUED THE PROCEDURE. THEN IN VITRO, IT WAS FOUND THAT THE OTHER HALF OF THE BROKEN COIL BODY WAS STUCK IN THE ECHELON 10 MICROCATHETER. NO FURTHER MEDICAL/SURGICAL INTERVENTION WAS REQUIRED, AND THE COIL WAS IMPLANTED IN THE INTENDED LOCATION. THE PUSHWIRE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995605 ↗
• MalfunctionMar 28, 2022Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING FILLING THE SPRING COIL, IT WAS STRETCHED WHEN FILLED HALFWAY. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS PULLED OUT SLOWLY FROM THE PATIENT. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929393 ↗
• MalfunctionMar 25, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STUCK IN SHEATH. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906272 ↗
• MalfunctionJul 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT AN AXIUM COIL DETACHED PREMATURELY DURING A PROCEDURE. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN REPOSITIONED THE COIL BUT DID NOT ROTATE THE DELIVERY PUSHER OR MAKE ANY DETACHMENT ATTEMPTS. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS SAFELY REMOVED WITH THE MICROCATHETER AND A COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173898 ↗
• InjuryNov 19, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THE COIL DETACHED IN THE MICROCATHETER, AND WAS SUCCESSFULLY REMOVED VIA THE CRANIOTOMY. THE MICROCATHETER USED WAS AN ECHELON 10, BUT IT WAS DISCARDED. THE PATIENT IS RECOVERING WELL AFTER THE SURGERY, AND THERE ARE NO ADVERSE EVENTS OR PATIENT COMPLICATIONS TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10869679 ↗

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