Axium PrimeTM APB-2.5-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536031906), received between Dec 5, 2020 and Dec 4, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO SYMPTOMS ASSOCIATED WITH THIS EVENT. THE MODEL NUMBER OF THE COIL THAT FAILED TO PASS THE MICROCATHETER HUB (LOT NUMBER A239068) B239068. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT; STRYKER SL-10.THE COIL¿S WIRE WAS BROKEN INSIDE THE BOX. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260162 ↗
• MalfunctionNov 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY IN THE CATHETER. THE COIL IS PRE-DETACHED AND MIGRATED IN THE MICROCATHETER. REMOVE THE CATHETER, REMOVE THE COIL, AND USE ANOTHER COIL. THE COIL IS PRE-DETACHED AND MIGRATED IN THE MICROCATHETER. REMOVE THE CATHETER, REMOVE THE COIL, AND USE ANOTHER COIL. SURGICAL OR MEDICAL INTERVENTION WAS NOT REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THEY DID NOT ROTATE THE DELIVERY PUSHER DURING INJECTION. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT A COM A LOCATION. THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 1.5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOM OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: FUBUKI 8F GUIDE CATHETER, HEADWAY17 MICROCATHETER, SYNCHRO14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712499 ↗
• MalfunctionSep 7, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE INTRODUCER SHEATH HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING THE HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435188 ↗
• MalfunctionAug 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL HAD PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4 MM AND A AN UNKNOWN NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS XXX AND VESSEL TORTUOSITY WAS XXX. IT WAS REPORTED THAT THERE WAS COIL PREMATURE DETACHMENT. THERE WAS NO SURGICAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ANCILLARY DEVICES INCLUDE A 6F ENVOY DA GUIDE CATHETER AND A PHENOM17, SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377569 ↗
• MalfunctionApr 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE COIL AND CATHETER WERE REMOVED, AND NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING DELIVERY, AND THE PHYSICIAN DID NOT REPOSITION THE COIL. NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED. 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 MIDDLE CEREBRAL ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE AN ENVOY DA GUIDE CATHETER AND STRYKER SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625577 ↗
• MalfunctionDec 5, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10952439 ↗