Axium PrimeTM APB-2-4-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536032187), received between Mar 23, 2020 and Oct 26, 2022 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionOct 26, 2022Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS PUSHED OUT OF THE MICROCATHETER AND WAS FOUND TO BE STRETCHED, AND THE PRIMARY WIRE OF THE COIL WAS SEPARATED. THE COIL DID NOT PREMATURELY DETACH FROM THE DELIVERY WIRE. A FRAGMENT OF THE COIL DID NOT BREAK OFF. IT WAS STATED THAT THE STRETCH WAS THE ONLY DAMAGE TO THE COIL. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673178 ↗
• InjuryJun 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE USE OF A STENT WAS ALREADY SCHEDULED, BUT A LARGER STENT HAD TO BE USED TO COVER BOTH THE ANEURYSM NECK AND TO EXCLUDE THE SPRING FROM THE CIRCULATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12040528 ↗
• MalfunctionFeb 1, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THE LOT NUMBER OF THE INSTANT DETACHER WAS UNKNOWN. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT ISSUE, AND IT WAS UNKNOWN IF THERE WAS ANY DAMAGE TO THE PUSHWIRE AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263554 ↗
• MalfunctionJan 25, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11223073 ↗
• MalfunctionMar 23, 2020Break; Incomplete or Missing Packaging; Break; Incomplete or Missing Packaging

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT HAVE A COIL AT THE TIP SIDE. A DIFFERENT COIL WAS USED FOR THE PROCEDURE, AND THERE WAS NO PATIENT HARM REPORTED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 4.56MM AND A 2.78MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865987 ↗