AxiumTM APB-2.5-8-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536021068), received between Apr 29, 2020 and Nov 3, 2021 — classified as 4 malfunctions.

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

• MalfunctionNov 3, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE REP CHECKED AGAIN WITH THE DOCTOR IF HE KNEW THAT THE PRODUCT WAS EXPIRED, HE DIDN'T RECOGNIZE IT. IT WAS NOT TRANSPLANTED INTO THE PATIENT'S BODY, AND THERE WAS NO HEALTH PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749872 ↗
• MalfunctionSep 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THREE AXIUM COILS PREMATURELY DETACHED BEFORE DEPLOYMENT. THE COILS WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE PATIENT'S BLOOD FLOW WAS NORMAL. ANCILLARY DEVICES INCLUDE A BOSTON SCIENTIFIC XF GUIDER SOFT TIP GUIDE CATHETER, EXCELSIOR SL-10 MICROCATHETER, AND TRANSEND EX-SOFT GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541084 ↗
• MalfunctionMar 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF AN ANTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 2.8MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.  IT WAS REPORTED THAT WHEN FILLING THE ANEURYSM, THE AXIUM COIL (MODEL: APB-5-15-3D-SS) WAS USED FOR FORMING THE HOOP. AFTER FILLING APPROXIMATELY 2/3 OF THE COIL INTO THE ANEURYSM, THE FORMATION WAS NOT SATISFACTORY AND REQUIRED ADJUSTMENT. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE PUSHER, IT WAS FOUND TO BE DETACHED. THE ECHELON MICROCATHETER WAS WITHDRAWN AND DIFFERENT CATHETER WAS USED WITH A STENT RETRIEVER TO CAPTURE THE DETACHED AXIUM COIL AND REMOVE IT FROM THE PATIENT'S BODY. THERE WAS NO DAMAGE OBSERVED TO THE COIL PUSHER. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING THE DELIVERY OF THE COIL. NO ATTEMPTS HAD BEEN MADE TO THE DETACH THE COIL AND THE PHYSICIAN TRIED ONLY ONCE TO REPOSITION THE COIL. THE PHYSICIAN DID NOT ROTATE THE PUSHER. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543952 ↗
• MalfunctionApr 29, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM COIL ENCOUNTERED RESISTANCE AND DID NOT EXIT THE SHEATH SMOOTHLY, AS THE DEVICE WAS UN ABLE TO EXIT OUT OF SHEATH. THE DEVICE WAS PREPARED AND USED PER INSTRUCTIONS FOR USE (IFU). BASED ON DEVICE ANALYSIS, THE COIL WAS FOUND TO HAVE BROKEN AND THE TIP HAD SEPARATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10010751 ↗