Axium Prime Detachable Coil System APB-2-3-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000313876), received between Jul 3, 2023 and Apr 9, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE COIL NON DETACHMENT WERE IDENTIFIED. AN INSTANT DETACHER WAS NOT USED FOR ANY DETACHMENT ATTEMPTS. TWO ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. NO ISSUES WERE ENCOUNTERED PRIOR TO THE NON DETACHMENT, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829845 ↗
• MalfunctionMay 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY AND POSTERIOR COMMUNICATING ARTERY, THE AXIUM PRIME BARE HX 2MM X 3CM EXTRA COIL EXPERIENCED A KINK/DAMAGE. THE PUSHER BECAME STUCK DUE TO STRETCH-RESISTANT SUTURES AFTER THE COIL DETACHMENT. THE PROCEDURE INVOLVED THE USE OF A FUBUKI 6F GUIDE CATHETER, SL-10 J, 90 MICROCATHETER, AND SYNCHRO14 GUIDEWIRE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE, AND A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN REPOSITIONED THE COIL 2-3 TIMES. THE PUSHWIRE'S DISTAL SEGMENT WAS IDENTIFIED AS THE LOCATION OF THE DAMAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE COIL KINK/DAMAGED WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE COIL KINK/DAMAGED: RETRIEVED THE PUSHER WIRE AFTER COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037304 ↗
• MalfunctionDec 30, 2024Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL STRETCHED WHEN IT WAS DELIVERED IN THE MICROCATHETER. THERE WAS FRICTION/DIFFICULTY DURING DELIVERY, AND THERE WAS NOTED TO BE COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENT, AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID NOT REPOSITION THE COIL, THE DELIVERY PUSHER WAS NOT ROTATED, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. A CONTINUOUS FLUSH HAD BEEN 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 RIGHT OPHTHALMIC ARTERY. THE MAX DIAMETER WAS 5.7MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21038384 ↗
• MalfunctionAug 22, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 1.5 MM AND A 1.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHEN TREATING THE RUPTURED ANTERIOR COMMUNICATING ANEURYSM, AFTER THE MICROCATHETER WAS IN PLACE, THE AXIUM ES COIL WAS INSERTED. AFTER DEPLOYMENT, IT WAS FOUND THAT THERE WAS STILL A DEVELOPING WIRE REMAINING IN THE MICROCATHETER. AFTER THE MICROCATHETER WAS WITHDRAWN, IT WAS FOUND THAT THE PROXIMAL BALL OF THE ANTI-STRETCHING WIRE OF THE SPRING COIL FAILED TO REBOUND INTO THE COIL BODY. SUSPECTED ANTI-STRETCHING WIRE RUPTURE, OBSERVED THAT THE COIL BODY WAS STABLE, AND ENDED THE SURGERY. IT WAS REPORTED THE COIL WAS KINKED/DAMAGED THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED LOCATED WAS ON THE IMPLANT COIL. THE PHYSICIAN REPOSITIONED THE COIL DURING THE PROCEDURE ONE TIME. IT WAS REPORTED THE AXIUM PRIME ES ANTI-STRETCHING WIRE BROKE. THE REPORTED DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042497 ↗
• MalfunctionJul 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE OPERATION THE COIL AUTOMATICALLY DETACHED IN ADVANCE. ACTIONS TAKEN TO RESOLVE THE ISSUE WAS USING THE AB STENT TO REMOVE THE DETACHED COIL. NO DETACHMENT ATTEMPTS WERE MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. NO ADDITIONAL MEDICINAL OR SURGICAL INTERVENTION WAS REQUIRED. THE COIL PREMATURELY DETACHED AT THE ANEURYSM NECK AND IT WAS REMOVED. THE CATHETER USED WAS AN ECHELON. THREE COILS WERE IMPLANTED BEFORE THE MALFUNCTIONED COIL AND TWO WERE IMPLANTED AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247623 ↗