Axium PrimeTM APB-3-8-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536031944), received between Jan 16, 2020 and Jul 21, 2021 — classified as 4 malfunctions.

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

• MalfunctionJul 21, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXUM PRIME COIL COULD NOT BE DETACHED AFTER 4-5 ATTEMPTS USING THE INSTANT DETACHER. MANUAL DETACHMENT WAS ATTEMPTED AS WELL, BUT THE COIL STILL COULD NOT BE DETACHED. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207237 ↗
• MalfunctionJun 1, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED CLARIFICATION THAT THE CATHETER WAS STRETCHED, NOT SEPARATED. THE CATHETER USED WAS A NON-MEDTRONIC DEVICE. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913441 ↗
• MalfunctionOct 23, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10727353 ↗
• MalfunctionJan 16, 2020Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM COIL WAS OBSERVED TO BE UNWINDING DURING THE PROCEDURE. PRIOR TO THE EVENT, THE MICROCATHETER WAS DELIVERED TO THE LESION THROUGH THE GUIDE CATHETER. THEN THE AXIUM COIL WAS PUSHED FROM THE MICROCATHETER AND THE SPRING COIL FILLING INTO THE TUMORS. THROUGH THE GUIDING CATHETER ANGIOGRAPHY TAMPONADE AND FOUND THERE WAS SOMETHING ABNORMAL, AND AGAIN THROUGH THE RAY, OBSERVING THE SPRING COIL WAS UNWINDING. THE SPRING COIL WAS TIMELY WITHDRAWN OUT OF THE BODY WITH MICROCATHETER AND GUIDING CATHETER. CONSIDERING THE PATIENT'S SITUATION, THE SURGERY WAS SUSPENDED. IT WAS NOTED THAT THERE WAS COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 5MM X 4MM LOCATED IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT¿S BLOOD FLOW WAS NORMAL AND THE VASCULATURE WAS MODERATE IN TORTUOSITY. THE PUSHWIRE WAS BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL AND DID NOT ATTEMPT TO DETACH THE COIL. THERE WAS NO ROTATING OF THE DELIVERY PUSHER DURING PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9598283 ↗