Axium PrimeTM APB-2-3-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536031883), received between Sep 24, 2019 and Jun 10, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED IN THE MICROCATHETER WHILE DEPLOYING. THE PUSHWIRE WAS NOT BENT OR BROKEN, THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, THE PHYSICIAN DID NOT REPOSITION THE COIL, THE DELIVERY PUSHER WAS NOT ROTATES, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. A CONTINUOUS FLUSH WAS ADMINISTERED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT ICA. THE MAX DIAMETER WAS 7MM, AND THE NECK DIAMETER WAS 5MM. ANCILLARY DEVICES INCLUDE AN ENVOY 7 GUIDE CATHETER AND AN SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655518 ↗
• MalfunctionJul 9, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE) DURING THE COILING TREATMENT OF ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL THREE TIMES WITH THE INSTANT DETACHER AND TWO TIMES WITH USING MANUAL METHOD BUT STILL COIL FAILED TO DETACH. THE COIL AND MICROCATHETER REMOVED I SET ASIDE FOR RETURN TO MEDTRONIC. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NOT ANY IMAGE AVAILABLE FOR REVIEW. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT¿S BLOOD FLOW NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A SMALL RUPTURED SACCULAR ANEURYSM LOCATED IN A1 SEGMENT, MEASURING 4MMX2MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10249004 ↗
• MalfunctionSep 24, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED TO DETACH WITHIN THE ANEURYSM. THE DEVICE WAS RETRIEVED WITHOUT ISSUE. ONCE THE DEVICE WAS REMOVED, THE COIL FELL ON THE FLOOR FROM WITHIN THE SL10 MICROCATHETER. A SECOND INSTANT DETACHER WAS NOT USED. MANUAL DETACHMENT WAS NOT ATTEMPTED. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109657 ↗