AXS Offset M003DC050150A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327361155), received between Dec 2, 2020 and Dec 8, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 16, 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.

• InjuryDec 8, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE RO MARKER OF CATHETER (SUBJECT DEVICE) DISLODGED FROM CATHETER AND BECAME STUCK IN MCA BRANCH. THE PHYSICIAN ATTEMPTED TO REMOVE THE RO MARKER FROM THE PATIENT'S ANATOMY BUT WAS NOT ABLE TO REMOVE FROM VESSEL. THE DETACHED RO MARKER OF SUBJECT CATHETER REMAINS INSIDE THE PATIENT'S ANATOMY. SURGICAL DELAY OF 3 HOURS WAS REPORTED AND THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STROKE LIKE SYMPTOMS AND IS UNDER ADDED MEDICATION. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient; Stroke/CVA

  MAUDE report 10970208 ↗
• MalfunctionDec 2, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE SUBJECT CATHETER'S RADIO OPAQUE (RO) MARKER DETACHED DURING PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10937051 ↗