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

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536032279), received between Nov 22, 2019 and Dec 1, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. NO ATTEMPT WAS MADE AT DETACHMENT; THE COIL WAS NEVER PUSHED OUT OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909015 ↗
• MalfunctionMay 13, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED COIL DETACHMENT WAS ATTEMPTED THREE TIMES WITH THE INSTANT DETACHER (ID), AND THE MANUAL DETACHMENT METHOD WAS PERFORMED ONCE. THERE WERE NO OTHER ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816408 ↗
• MalfunctionNov 22, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE AXIUM COILS COULD NOT BE DETACHED USING 2 DIFFERENT INSTANT DETACHERS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE COILS COULD NOT BE DETACHED IN ANEURYSM. THE USE OF A NEW DETACHER DID NOT WORK. THE COIL WAS WITHDRAWN FROM THE ANEURYSM, A SECOND COIL WAS USED INSTEAD WHICH ALSO COULD NOT BE DETACHED. THE SECOND COIL WAS ALSO WITHDRAWN AND REPLACED BY A THIRD COIL WHICH COULD ALSO NOT BE DETACHED. IT WAS UNKNOWN HOW MANY ATTEMPTS WERE PERFORMED TO DETACHED THE COIL WITH THE INSTANT DETACHER. A MANUAL ATTEMPT WAS NOT DONE VIA THE HYPOTUBE. IT WAS NOTED ALL PRODUCTS WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. REFER TO MANUFACTURER REPORT 2029214-2019-01157 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9362376 ↗
• MalfunctionNov 22, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE AXIUM COILS COULD NOT BE DETACHED USING 2 DIFFERENT INSTANT DETACHERS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE COILS COULD NOT BE DETACHED IN ANEURYSM. THE USE OF A NEW DETACHER DID NOT WORK. THE COIL WAS WITHDRAWN FROM THE ANEURYSM, A SECOND COIL WAS USED INSTEAD WHICH ALSO COULD NOT BE DETACHED. THE SECOND COIL WAS ALSO WITHDRAWN AND REPLACED BY A THIRD COIL WHICH COULD ALSO NOT BE DETACHED. IT WAS UNKNOWN HOW MANY ATTEMPTS WERE PERFORMED TO DETACHED THE COIL WITH THE INSTANT DETACHER. A MANUAL ATTEMPT WAS NOT DONE VIA THE HYPOTUBE. IT WAS NOTED ALL PRODUCTS WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. REFER TO MANUFACTURER REPORT 2029214-2019-01157 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9362326 ↗
• MalfunctionNov 22, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE AXIUM COILS COULD NOT BE DETACHED USING 2 DIFFERENT INSTANT DETACHERS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE COILS COULD NOT BE DETACHED IN ANEURYSM. THE USE OF A NEW DETACHER DID NOT WORK. THE COIL WAS WITHDRAWN FROM THE ANEURYSM, A SECOND COIL WAS USED INSTEAD WHICH ALSO COULD NOT BE DETACHED. THE SECOND COIL WAS ALSO WITHDRAWN AND REPLACED BY A THIRD COIL WHICH COULD ALSO NOT BE DETACHED. IT WAS UNKNOWN HOW MANY ATTEMPTS WERE PERFORMED TO DETACHED THE COIL WITH THE INSTANT DETACHER. A MANUAL ATTEMPT WAS NOT DONE VIA THE HYPOTUBE. IT WAS NOTED ALL PRODUCTS WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9362304 ↗