AxiumTM APB-2.5-3-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536021037), received between Jul 21, 2022 and Dec 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2022Break; Separation Failure; Break; Separation Failure

  NEW INFORMATION WAS RECEIVED. THE PATIENT IS RECOVERING FROM THE PROCEDURE NORMALLY. TO CLARIFY THE REPORT OF "IT BROKE WHEN USING THE COIL" MEANT THE COIL WAS UNRAVELING. WHEN ASKED IF THE COIL FRACTURED AND SEPARATE FROM THE REST IT WAS ANSWERED THAT THE COIL WAS UNRAVELING. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE COIL WAS REMOVED FROM THE PATIENT. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052423 ↗
• MalfunctionSep 12, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME COIL COULD NOT BE DETACHED. THREE DETACHMENT ATTEMPTS HAD BEEN MADE WITH THE INSTANT DETACHER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 1.5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406696 ↗
• MalfunctionJul 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT AFTER THE AXIUM COIL WAS SUCCESSFULLY DETACHED WITH THE INSTANT DETACHER (ID), THE PUSHWIRE WAS STUCK IN THE ID AND COULD NOT BE REMOVED. THE PUSHWIRE WAS REMOVED FROM THE PATIENT'S BODY WHILE STILL ATTACHED TO THE DETACHER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075010 ↗