Axium PrimeTM APB-2-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536032163), received between Jan 25, 2022 and May 11, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL HAD PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM IN THE LEFT C7 SEGMENT WITH A MAX DIAMETER OF 6.5 X 6.2 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE DETACHABLE SPRING COIL APB-2-2-HX-ES ACCIDENTALLY DETACHED EARLY WHEN PASSING THROUGH THE Y VALVE, AND COULD NOT CONTINUE TO DELIVER. SUBSEQUENT REPLACEMENT OF OTHER COIL COULD BE DELIVERED NORMALLY AT THE Y VALVE. THE OPERATOR BELIEVED THAT THE COIL WAS A QUALITY PROBLEM. IT WAS REPORTED THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. IT WAS REPORTED THE COIL HAD NOT ENTERED THE HUMAN BODY, HAD BEEN TAKEN OUT. THERE WERE NO SURGICAL OR MEDICINAL INTERVENTIONS 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. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910690 ↗
• MalfunctionJan 25, 2022Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED REPORT THAT WHEN THE AXIUM COIL (MODEL APB-2-2-HX-ES, LOT: B197786) WAS DELIVERED INTO THE ANEURYSM SAC, THE COIL COULD NOT BE DETACHED. THE COIL WAS REMOVED AND REPLACED. IT WAS OBSERVED THAT THE MIDDLE SEGMENT OF THE PUSHER WAS DAMAGED. THERE HAD NOT BEEN ANY FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL BUT THE PHYSICIAN DID ROTATE THE PUSHER. WHEN THE AXIUM COIL (MODEL: APB-1.5-2-HX-ES, LOT: 222087536) WAS BEING DELIVERED, THE TIP OF THE COIL WAS STRETCHED SO THE DEVICE WAS REMOVED AND REPLACED. IT WAS NOTED THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN DID NOT ROTATE THE PUSHER DURING THE DELIVER. INFORMATION IN THE REPORT ALSO INDICATED THAT BOTH COILS DETACHED PREMATURELY AS WELL; THE PHYSICIAN HAD NOT ATTEMPTED TO DETACH THE 1.5-2 COIL. IT WAS NOTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED FUSIFORM POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER 6.1MM AND THE NECK DIAMETER 3.9MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342861 ↗