SAM XT Extremity Tourniquet XT600-BK-ENRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822045000209), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 malfunction.

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

• MalfunctionFeb 17, 2023Break; Break

  A POLICE OFFICER ATTEMPTED TO PLACE A SAM XT ON THE RIGHT THIGH OF A PATIENT WITH AN OPEN COMPOUND TIBIA/FIBIA FRACTURE SUSTAINED IN CAR VS. BICYCLE COLLISION AFTER THE PREVIOUSLY APPLIED CAT TOURNIQUET WAS NOT OCCLUDING BLEEDING. WHEN THE SAM XT WINDLASS WAS TIGHTENED, THE BUCKLE FRAME BROKE. A SECOND TOURNIQUET WAS PLACED ON THE THIGH, AND THE BLEEDING STOPPED. THE PATIENT WAS TRANSPORTED TO HOSPITAL BY AMBULANCE FOR TREATMENT OF INJURIES. THE BROKEN XT WAS RETAINED FROM THE SCENE FOR INVESTIGATION, BUT THE BROKEN BUCKLE WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16398930 ↗