Axium Prime Detachable Coil System APB-5-15-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536038578), received between Jun 28, 2022 and Jul 31, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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.

• MalfunctionJul 31, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE/WAS STUCK IN THE CATHETER DURING DELIVERY AND WAS DAMAGED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM THAT HAD A MAX DIAMETER WAS 6.4MM AND 2.4MM NECK. PATIENT'S BLOOD FLOW WAS NORMAL; VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS POSITIONED AT THE TARGET SITE AND THE COIL WAS INTRODUCED. THE COIL HAD RESISTANCE AND WAS STUCK IN THE CATHETER. NECESSARY ADJUSTMENT WAS MADE TO ENSURE ACCURATE PLACEMENT BUT THE COIL SEEMED OBSTRUCTED IN THE CATHETER, PREVENTING IT FROM EXITING THE CATHETER TIP. THE SYSTEM WAS REMOVED TOGETHER TO ALLOW FOR REPOSITIONING OF THE CATHETER. UPON REMOVAL, THE COIL WAS FOUND TO BE DAMAGED. THE CATHETER WAS NOT DAMAGED. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE RESISTANCE WAS ENCOUNTERED AT THE DISTAL PART OF THE CATHETER. THE COIL INITIALLY CAME OUT WITH RESISTANCE, UNLIKE THE PREVIOUS COIL, AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680299 ↗
• MalfunctionMar 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULDN'T BE RELEASED INTO THE HUB AND THE COIL COULDN'T COME OUT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A 7F SHEATH AND ECHELON MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE CATHETER OR COIL AFTER REMOVAL. A CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679364 ↗
• MalfunctionDec 2, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE AND BECAME STUCK IN THE MIDDLE OF THE CATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR NEUROVASCULAR ABNORMALITIES (E.G. ARTERIOVENOUS MALFORMATIONS OR FISTULAE) WITH A CCF GRADE TYPE OF ABNORMALITY. IT WAS UNKNOWN IF THE ABNORMALITY WAS LOCATED IN THE ELOQUENT REGION. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE CATHETER WAS NOT DAMAGED. IT WAS UNKNOWN IF THE COIL WAS DAMAGED. IT WAS A CCF CASE AND WHEN PUSHING COILS THROUGH THE CATHETER, THEY FACED HIGH RESISTANCE. COIL (LOT # 228640123) PUSHWIRE WAS DAMAGED AT THE PROXIMAL SEGMENT. THE HEALTHCARE PROVIDER REMOVED THE COILS AND WENT WITH OTHER COILS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BEING TREATED FOR A 6MM CAROTID CAVERNOUS FISTULA. VESSEL TORTUOSITY WAS MODERATE. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE COIL CAME OUT VERY SMOOTHLY FROM THE SHEATH. THE CATHETER USED WAS NOT A MEDTRONIC PRODUCT. THERE WERE NO ISSUES THAT RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824749 ↗
• InjuryJun 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY AND REQUIRED ADDITIONAL INTERVENTION TO PREVENT PATIENT INJURY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 16MM AND THE NECK DIAMETER WAS 9MM. BLOOD FLOW WAS HIGH. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL DETACHED PREMATURELY 3CM FROM THE ANEURYSM SAC IN THE A1 SEGMENT AND RIGHT SUPRACLINOID SEGMENT AT THE ORIGIN OF THE POSTERIOR COMMUNICATING ARTERY. IT WAS NOTED THAT THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN HAD NOT REPOSITIONED THE COIL, ROTATED THE PUSHWIRE, OR ATTEMPTED TO DETACH THE COIL. CONTINUOUS CATHETER FLUSHED WAS ADMINISTERED DURING THE PROCEDURE. A STENT WAS IMPLANTED FROM THE LEFT A2 TO ALL OF THE RIGHT A1 AND ANOTHER STENT WAS IMPLANTED FROM THE M1 SEGMENT TO THE RIGHT OPHTHALMIC SEGMENT TO SECURE THE COIL AND PREVENT PATIENT INJURY. TIROFIBAN WAS ADMINISTERED TO PREVENT THROMB

  Patient problems: Foreign Body In Patient

  MAUDE report 14842632 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab