AxiumTM APB-2.5-4-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536021044), received between Oct 7, 2019 and Sep 29, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 29, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS OPENED AND REMOVED FROM THE HOOP, AND WHEN THE DELIVERY PUSHER WAS PUSHED OUT TO TAKE THE COIL OUT OF THE SLEEVE INTO THE SALINE SOLUTION ACCORDING TO NORMAL PREPARATION, A LONG SPAN OF PUSHING CAUSED A KINK AND THE COIL WAS SEPARATED. ANOTHER PRODUCT WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. IT WAS NOTED THAT THE PROXIMAL SECTION OF THE PUSHER WAS KINKED/BROKEN. IT WAS UNKNOWN IF THERE WAS ANY RESISTANCE DURING PREPARATION OR USE. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. IT WAS NOTED THAT THE EVENT WAS NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844672 ↗
• MalfunctionJul 31, 2023Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THE AXIUM COIL DEVICE WAS ALREADY DAMAGED WHEN THE PACKAGE WAS OPENED. IT WAS NOTED THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS PREP PERFORMED PRIOR TO THE DAMAGE BEING SEEN. THE DEVICE WAS USED IN THE PROCEDURE WITH THE PATIENT. THERE WERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. IT WAS UNKNOWN IF THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17426256 ↗
• MalfunctionFeb 2, 2022Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT BEFORE THE STERILIZED PRODUCT WAS OPENED, A FORCED DETACHMENT WAS CONFIRMED. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13434613 ↗
• InjuryNov 7, 2021Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN INFECTION. THERE WAS A KINK AT THE PROXIMAL PART OF THE PUSHER AND THERE WAS RESISTANCE DURING PREPARATION OR USE. AFTER REPLACING THE DEVICE, THE 4 PRIMES WERE INSERTED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED. A FLUSH WAS PERFORMED WITHOUT INTERRUPTION AT THE DAMAGED POSITION. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE M2 BIFURCATION WITH A MAX DIAMETER OF 4MM AND A 3.2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: Unspecified Infection

  MAUDE report 12764346 ↗
• MalfunctionSep 18, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ISSUES WERE ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT. THREE ATTEMPTS HAD BEEN MADE TO DETACH THE COIL USING THE INSTANT DETACHER, AND ONE ATTEMPT WAS MADE USING THE MANUAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10551872 ↗
• MalfunctionOct 24, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED, A-COM ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THREE COMPETITOR'S COILS WERE INSERTED FOR THE RUPTURED ANEURYSM, AND THE MEDTRONIC AXIUM PRIME COIL WAS INSERTED AS THE FOURTH COIL. AN ATTEMPT WAS MADE TO DETACH USING THE ID-1 TWICE, BUT IT FAILED. THE MANUAL DETACHMENT METHOD WAS PERFORMED, BUT IT ALSO FAILED. THE DEVICE WAS SAFELY RECOVERED WITHOUT BEING DETACHED IN THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S PRODUCT. IT WAS NOTED ALL PRODUCTS WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9233619 ↗
• MalfunctionOct 7, 2019Separation 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). THE PATIENT UNDERWENT EMBOLIZATION TREATMENT A SMALL UNRUPTURED SACCULAR LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM, MEASURING 5MMX24MM. THE VESSEL WAS NORMAL TORTUOUS. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL TWO TIMES WITH FIRST INSTANT DETACHER AND TWO TIMES WITH SECOND INSTANT DETACHER BUT DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING MANUAL METHOD FIVE TIMES BUT STILL COIL DID NOT DETACH. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT¿S BLOOD FLOW WAS NORMAL. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9163390 ↗