Axium Prime Detachable Coil System APB-2-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000313678), received between Dec 19, 2022 and Sep 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Separation Failure; Detachment of Device or Device Component; Migration; Physical Resistance/Sticking

  Medtronic received a report of Axium coil detachment after non-detachment. The patient was undergoing surgery for treatment of a saccular, ruptured "comunicante" anterior aneurysm with a max diameter of 4 mm and a 3 mmneck diameter. It was noted the patient's blood flow was normal and vessel tortuosity was moderate. The reported event occurred during normal use, i.e during the life of an implanted device; after post-op and before explant. It was reported that at the time of release of the device, the Axium coil detached erratically, causing a part of it to prolapse into the left anterior cerebral artery. As a result of this event, a thrombosis of the compromised vessel occurred, generating an intraprocedural complication. As a rescue measure, a stent was implanted in order to restore blood circulation and maintain vascular permeability. The coil was stuck in the sheath and had non-detachment. The physician attempted to detach the coil with the Instant Detacher three times. The physician did not try to detach with another Instant Detacher. There was one manual method at detachment attempted via hypotube. There was no issue with the Instant Detacher. The device and any accessories we

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50867752 ↗
• MalfunctionFeb 10, 2026Break; Stretched; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305700 ↗
• MalfunctionMay 8, 2025Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Migration; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Migration

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL ESCAPED FAR AWAY AND WAS NOT TREATED. THE SURGEON COULD NOT DETERMINE SPECIFICALLY WHICH COIL ESCAPED. THE CAUSE OF THE COIL PREMATURE DETACHMENT AND MIGRATION WAS NOT DETERMINED. THERE WERE 3 COILS IMPLANTED BEFORE AND AFTER THE MALFUNCTIONED COIL. THE PATIENT HAS NOT RECEIVED ANY MEDICAL/SURGICAL INTERVENTION AS A RESULT OF THE MIGRATION AND NO ANTIPLATELET REGIMEN WAS ADMINISTERED.

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

  MAUDE report 21987175 ↗
• MalfunctionApr 7, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 2MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. THE PARENT VESSEL WAS THE LEFT INTERNAL CAROTID ARTERY WITH A DIAMETER OF 4MM. IT WAS REPORTED THAT WHEN TREATING THE ANEURYSM, THE COIL WAS DELIVERED AFTER THE MICROCATHETER WAS IN PLACE. THE COIL WAS AUTOMATICALLY DETACHED IN THE BLOOD VESSEL AND ESCAPED TO THE MIDDLE CEREBRAL ARTERY, SO THE SOLITAIRE AB STENT WAS USED TO SUCCESSFULLY GRAB AND PULL IT OUT OF THE BODY. THEN ANOTHER BRAND OF COIL AND AUXILIARY STENT WERE USED TO END THE OPERATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, ATTEMPT TO DETACH, OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21787496 ↗
• MalfunctionJan 2, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A RUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY, A COIL FROM THE AXIUM COIL BECAME STUCK IN THE SHEATH. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 5 MILLIMETERS AND A NECK DIAMETER OF 2 MILLIMETERS, WITH MODERATE VESSEL TORTUOSITY AND NORMAL BLOOD FLOW. THE DEVICES, INCLUDING A MICROCATHETER (ECHELON) AND A GUIDEWIRE (AVIGO), WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE ISSUE INVOLVED COIL RESISTANCE AND THE COIL BEING STUCK IN THE SHEATH. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL ACCIDENTALLY BROKE DURING THE PROCEDURE, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063993 ↗
• MalfunctionAug 31, 2023Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT UPON OPENING THE OUTER PACKAGE, IT WAS OBSERVED THAT THE AXIUM PUSHER WAS KINKED A THE COIL DETACHMENT POINT. IT WAS NOTED THAT THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY OF THE COIL. THE COIL WAS NOT IMPLANTED REPLACED WITH ANOTHER MODEL OF COIL TO COMPLETE THE PROCEDURE SUCCESSFULLY.  THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. IT WAS NOTED THAT THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED 3.31MM X 2.95MM SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH 2.67MM ANEURYSM NECK DIAMETER. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DAMAGE WAS NOT NOTICED UPON OPENING THE PACKAGE. THERE WAS NO PREP PERFORMED PRIOR TO THE DAMAGE BEING SEEN. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662341 ↗
• MalfunctionDec 19, 2022Break; Stretched; Separation Failure; Detachment of Device or Device Component; Break; Stretched; Separation Failure; Detachment of Device or Device Component

  NEW INFORMATION WAS RECEIVED. TO CLARIFY THE IF THE COIL SEPARATED/PREMATURELY DETACHED, THE COIL WAS STRETCHED INSIDE THE MICROCATHETER WHEN BEING PUSHED. THE ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND WAS THE COIL WAS STRETCHED. UNDER DAS, THERE WAS RESIS TANCE DURING PUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16007112 ↗