Axium PrimeTM APB-1.5-3-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536031852), received between Feb 2, 2021 and Jul 22, 2021 — classified as 2 malfunctions.

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

• MalfunctionJul 22, 2021Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER IMPLANTING THE 1.5-3ES SPRING COIL, THE COIL COULD NOT BE DETACHED AFTER 5 ATTEMPTS WITH THE INSTANT DETACHER. A SECOND INSTANT DETACHED WAS NOT USED, AND THE MANUAL DETACHMENT METHOD WAS PERFORMED TWICE, BUT DETACHMENT WAS STILL UNSUCCESSFUL. IT WAS STATED THERE WAS NO ISSUE WITH THE INSTANT DETACHER. A REPLACEMENT COIL (1.5-2ES) WAS USED AND DETACHED 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 FUSIFORM, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 4.2 MM AND A 3.7 MM 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 12211315 ↗
• MalfunctionFeb 2, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THREE DETACHMENTS HAD BEEN MADE WITH THE INSTANT DETACHER, AND ONE MANUAL DETACHMENT ATTEMPT HAD BEEN MADE WITH A PULL OF THE INNER WIRE. PRIOR TO THE NON-DETACHMENT THERE HAD NOT BEEN ANY ISSUES, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE AFTER REMOVAL. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE, WITH THE ONLY DEVIATION THAT A HEADWAY DUO 167CM .013 ID CATHETER WAS USED. THE PATIENT WAS BEING TREATED FOR FUSIFORM VESSEL SACRIFICE IN THE POSTERIOR INFERIOR CEREBELLAR ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267241 ↗