TriForce G56412Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002564121), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING A PATIENT WITH CENTRAL VENOUS STENOSIS, THE TIP OF A TRIFORCE PERIPHERAL CROSSING SET'S SHEATH SPLIT. ACCESS WAS OBTAINED IN THE RIGHT UPPER ARM TO TARGET THE BRACHIAL VEIN, AND THE ANATOMY WAS VERY CALCIFIED. THE HYDROPHILIC COATING WAS ACTIVATED, AND THE SHEATH WAS ADVANCED WITH THE DILATOR, PRIOR TO CATHETER ADVANCEMENT. THE DEVICE WAS USED TO CROSS A CHRONIC OCCLUSION. RESISTANCE WAS NOT FELT DURING INSERTION OR REMOVAL OF THE DEVICE; HOWEVER, WHEN THE DEVICE WAS REMOVED, THE USER NOTED THAT THE SHEATH TIP HAD SPLIT. A POWER INJECTOR WAS NOT USED. THE VESSELS WERE NOT DAMAGED. ANOTHER MANUFACTURER'S GRAFT WAS USED TO COMPLETE THE PROCEDURE. PER THE REPORTER, THE GRAFT WAS NOT PLACED DUE TO THE SPLIT IN THE SHEATH TIP, BUT WAS ALREADY PLANNED IF THE OCCLUSION WAS UNABLE TO BE CROSSED, WHICH IT WASN'T. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072482 ↗