Axium Prime Detachable Coil System APB-6-20-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536038608), received between Jun 13, 2023 and Mar 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING SEGMENT ANEURYSM WITH A MAX DIAMETER OF 8 MM AND A 5.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING TREATMENT OF THE ANEURYSM, AFTER THE MICROCATHETER WAS POSITIONED IN PLACE, A COIL WAS SUCCESSFULLY FILLED TO FORM A HOOP. WHEN DELIVERING THIS COIL, AFTER THE COIL BODY ENTERED THE ANEURYSM SAC, THE DISTRIBUTION WAS UNSATISFACTORY. WHILE PREPARING TO ADJUST THE COIL BODY, DURING WITHDRAWAL IT WAS FOUND THAT THE COIL HAD SPONTANEOUSLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PUSHER ROD WAS WITHDRAWN, ANOTHER COIL WAS FILLED, THE COIL WITHIN THE MICROCATHETER WAS ADVANCED INTO THE ANEURYSM SAC, AND SUBSEQUENT FINISHING COIL WAS FILLED, AFTER WHICH THE PROCEDURE WAS COMPLETED. THE COIL REMAINED IN THE PATIENT. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THERE WERE NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664321 ↗
• MalfunctionJun 13, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED LEFT MIDDLE CEREBRAL ARTERY M1 BIFURCATION ANEURYSM WITH A MAX DIAMETER OF 14MM AND A 7MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT WHEN TREATING THE RUPTURED AORTIC ANEURYSM AT THE M1 BIFURCATION OF THE LEFT MIDDLE CEREBRAL ARTERY, AFTER THE ECHELON WAS IN PLACE, THE FC COIL FIRST FORMED A HOOP AND WAS NOT DETACHED. AFTER THE STENT MICROCATHETER WAS IN PLACE, THE EP STENT WAS DEPLOYED SMOOTHLY, AND THEN ANOTHER ECHELON WAS PIERCED THROUGH THE MESH, AND THE PRIME SS 6-20 WAS READY TO BE FILLED IN FOR DOUBLE MICROCATHETER EMBOLIZATION. DURING THE PROCESS OF FILLING IN THE COIL, THE RESISTANCE WAS NORMAL, AND THERE WAS NO OBVIOUS RESISTANCE DURING ADJUSTMENT. DURING THE OPERATION, THE COIL WAS FOUND TO BE STRETCHED, SO THE COIL WAS WITHDRAWN. ALTHOUGH IT INTERACTED WITH THE FC THAT FORMED THE HOOP BEFORE, BUT BECAUSE OF THE STENT, THE STRETCHED SS WAS SUCCESSFULLY WITHDRAWN FROM THE BODY COMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118063 ↗

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