Axium Prime Detachable Coil System APB-3-10-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000313982), received between Aug 17, 2021 and Dec 26, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Break; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Break; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED CEREBRAL ANEURYSM. IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE USING A FLOW DIVERTER, THE PIPELINE DEVICE WAS CORRECTLY POSITIONED AT THE LEVEL OF THE ANEURYSM NECK. THE ECHELON MICROCATHETER WAS PROPERLY ANCHORED INSIDE THE ANEURYSM AND TWO COILS HAD BEEN PREVIOUSLY IMPLANTED WITHOUT INTERCURRENCES. AT THE TIME OF THE ATTEMPT TO IMPLANT THE THIRD MICROCOIL, EARLY DETACHMENT OF THE DEVICE WAS OBSERVED, BEFORE ITS COMPLETE AND ADEQUATE ACCOMMODATION INSIDE THE ANEURYSM. AS A CONSEQUENCE, PART OF THE MICROCOIL REMAINED INSIDE THE ANEURYSM, WHILE THE OTHER PART WAS PROJECTED OUT OF THE ANEURYSM NECK. IT IS NOTEWORTHY THAT, DURING THE PREPARATION OF THE MATERIAL, NO APPARENT DAMAGE TO THE DEVICE WAS IDENTIFIED, NOR WAS THERE ANY ABNORMAL RESISTANCE DURING THE REMOVAL OF THE MICROSPRING FROM THE HIVE, FOLLOWED BY THE INSTRUCTIONS FOR USE. THE COIL REMAINED IN THE PATIENT AND WAS NOT IMPLANTED AT THE INTENDED LOCATION. FACED WITH THE EARLY DETACHMENT OF THE MICROSPRING AND THE NEED TO STABILIZE THE ANEURYSM, IT WAS DECIDED TO IMPLANT A

  Patient problems: Foreign Body In Patient

  MAUDE report 23896821 ↗
• MalfunctionMar 16, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR THOUGHT THESE TWO AXIUM WERE DEFECTIVE TO CAUSE THE POOR VISUALIZATION DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561098 ↗
• InjuryAug 17, 2021Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS DETACHED USING AN INSTANT DETACHER. AS THE PUSHWIRE WAS PULLED BACK, THE PHYSICIAN NOTICED SOMETHING THIN VISIBLE ON THE SCREEN STILL ATTACHED TO THE COIL. AT THE MICROCATHETER HUB, A HAIR LIKE FILAMENT WAS PRESENT. THE FILAMENT COULD NOT BE PULLED AS IT WAS STILL CONNECTED TO THE COIL. AS THE LEFT JUGULAR VEIN WAS OCCLUDED, THE PHYSICIAN PUSHED OUT THE FILAMENT IN THE VEIN AND IT WAS LEFT IMPLANTED. THERE WAS NO FUTURE PLAN OR INTENTION TO REMOVE THE FILAMENT FROM THE PATIENT BODY. THE PHYSICIAN ACKNOWLEDGED THEY PUT SOME FORCE ON THE COIL WHILE REPOSITIONING WHICH MAY HAVE CAUSED THE COIL STRETCH, BUT DID NOT THINK THE FILAMENT WAS A STRETCHED COIL. ONCE THE FILAMENT WAS STATIONED IN THE PATIENT' VEIN, THE MICROCATHETER WAS REPOSITIONED, AND THE PROCEDURE WAS COMPLETED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNSPECIFIED NEUROVASCULAR ABNORMALITY OF THE LEFT SIGMOID SINUS WITH NORMAL VESSEL TORTUOSITY. ANCILLARY DEVICES INCLUDE A HEADWAY DUO.

  Patient problems: Foreign Body In Patient

  MAUDE report 12332843 ↗