Axium PrimeTM APB-1-1-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536032088), received between Mar 18, 2021 and Dec 20, 2021 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LARGE RESISTANCE OCCURRED DURING RETRIEVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048605 ↗
• MalfunctionJun 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING EMBOLIZATION, THE COIL WAS PREMATURELY DETACHED. THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE COIL INTO THE ANEURYSM, BUT THE COIL WAS NOT IMPLANTED/POSITIONED IN THE INTENDED LOCATION. THE PUSHWIRE WAS NOT DAMAGED, THERE WAS NO FRICTION EXPERIENCED, NO DETACHMENT ATTEMPTS MADE, NO REPOSITIONING OF THE COIL PERFORMED, NO ROTATION OF THE PUSHWIRE WAS DONE, AND A CONTINUOUS FLUSH HAD NOT BEEN USED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. 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 A SACCULAR, RUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 11945989 ↗
• InjuryMar 18, 2021Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A TRANSLATION ERROR IN THE INITIAL REPORT; THE COIL WAS DETACHED BUT NOT STRETCHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11515577 ↗