T2 ALPHA 2341-1230SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327291056), received between Nov 12, 2025 and Nov 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Device Difficult to Setup or Prepare; Mechanical Jam; Device Difficult to Setup or Prepare; Mechanical Jam

  AS REPORTED: "AFTER INSERTING THE NAIL, THE SURGEON ATTEMPTED TO REMOVE THE GUIDEWIRE, BUT IT FAILED. THE PROCEDURE WAS STOPPED AND THE NAIL AND GUIDEWIRE WERE REMOVED FOR CONFIRMATION. WHEN WE CHECKED WHETHER THE WIRE COULD BE PASSED THROUGH THE NAIL OUTSIDE THE PATIENT'S BODY, THE GUIDE WIRE GOT STUCK INSIDE THE NAIL AND COULD NOT BE PASSED THROUGH. THE NAIL WAS REPLACED WITH ONE SIZE SHORTER AND THE PROCEDURE CONTINUED." THIS RESULTED IN A 30 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532385 ↗