Axium PrimeTM FC-7-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536034273), received between Jun 7, 2022 and Jun 28, 2023 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2023Break; Stretched; Break; Stretched

  MEDTRONIC RECEIVED INFORMATION THAT A FRAMING COIL STRETCHED AND BROKE. THE DAMAGED SECTION WAS IN THE PUSHWIRE PROXIMAL SEGMENT. THE PATIENT HAD AN ASSOCIATED RIGHT SIDE STROKE. DURING THE RETRACTION OF THE 7X30 FRAME 3D, THE COIL STRETCHED. ATTEMPTED TO SNARE THE COIL; UPON SNARING, THE COIL BROKE OFF AND REMAINED IN THE PATIENT. ONCE IMAGING WAS OBTAINED, THE INTERNAL CAROTID ARTERY (ICA) HAD CLOTTED OFF. ATTEMPTED TO ASPIRATE BUT WAS UNSUCCESSFUL. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR TESTING. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN REPOSITIONED THE COIL DURING THE PROCEDURE 3 TIMES. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. ATTEMPTED TO SNARE THE COIL BUT FAILED, THEN THE ICA CLOTTED OFF. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR NEUROVASCUALR ABNORMALITIES. IT WAS NOT IN THE ELOQUENT REGION. PATIENT BLOOD FLOW WAS LOW AND VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: Device Embedded In Tissue or Plaque; Stroke/CVA

  MAUDE report 17221235 ↗
• MalfunctionJun 7, 2022Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS PRE-DETACHED AFTER UNPACKING. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE COIL WAS NOT IMPLANTED IN THE PATIENT. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ICA PARACLINOID WITH A MAX DIAMETER OF 8MM AND A 3.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622653 ↗