Axium Prime Detachable Coil System APB-3-4-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000313951), received between Jan 6, 2025 and Jan 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJan 2, 2026Unintended Movement

  ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE CATHETER DISPLACEMENT WAS DETERMINED TO BE TENSION IN THE MICROCATHETER. THERE WAS SIGNIFICANT TENSION BECAUSE, UPON REACHING THE ANEURYSM WITH THE COIL, THE SYSTEM FELT SO RIGID THAT THE COIL WOULD NOT DEPLOY WITHIN THE ANEURYSM, GENERATING TENSION. DURING THE INITIAL ASCENT, NO FRICTION WAS FELT; THE TENSION WAS EXPERIENCED WHEN THE COIL REACHED THE DISTAL SEGMENT.

  Patient problems: Hemorrhagic Stroke; Ruptured Aneurysm

  MAUDE report 23945405 ↗
• MalfunctionDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM EMBOLIZATION, WHILE ADJUSTING THE POSITION OF THE COIL INSIDE THE ANEURYSM, THE COIL WAS WITHDRAWN OUT OF THE ANEURYSM. WHEN IT REACHED THE PROXIMAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY, THE COIL DETACHED AUTOMATICALLY. THE COIL WAS THEN RETRIEVED AND REMOVED FROM THE BODY USING A GUIDEWIRE AND SNARE. IT WAS FOUND THAT THE PROXIMAL DETACHMENT POINT WAS NOT KINKED, INDICATING THAT THE DETACHMENT WAS NOT DUE TO OPERATOR ERROR. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THERE WAS COIL PREMATURE DETACHMENT. THE IMPLANT COIL WAS REMOVED FROM THE PATIENT. IT WAS REMOVED FROM THE BODY USING A GUIDEWIRE AND SNARE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH A MAX DIAMETER OF 3.5 MM AND A 2.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764549 ↗
• MalfunctionJan 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079724 ↗