TriForce G56415Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002564152), received between May 16, 2017 and Sep 3, 2025 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 3, 2025Break; Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A TRIFORCE PERIPHERAL CROSSING SET BROKE. PER THE REPORTER, THE TIP APPEARS TO BE PARTIALLY ATTACHED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE TIP OF THE SHEATH WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955897 ↗
• MalfunctionFeb 4, 2020Material Separation; Material Separation

  AS REPORTED, DURING A RECANALIZATION PROCEDURE OF THE FEMORAL VEIN INVOLVING A PATIENT WITH DEEP VEIN THROMBOSIS, A TRIFORCE PERIPHERAL CROSSING SET SHEATH KINKED UPON ADVANCEMENT INTO A CHRONIC CLOT. ACCESS WAS OBTAINED IN THE BACK OF THE LEG. THE ANATOMY WAS REPORTED TO BE CALCIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S SHEATH, USING THE CATHETER INCLUDED WITH THE TRIFORCE PERIPHERAL CROSSING SET. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 03FEB2020, THE SHEATH WAS NOTED TO BE PARTIALLY SEPARATED IN TWO PLACES. THE TIP WAS ALSO NOTED TO BE DAMAGED. 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 Consequences Or Impact To Patient

  MAUDE report 9667157 ↗
• MalfunctionMay 16, 2017Peeled/Delaminated

  AS THE FACILITY WAS PREPPING THE DEVICE BEFORE THE PROCEDURE, IT WAS NOTED THAT THE SHEATH'S MATERIAL WAS PEELING OFF TOWARDS THE END OF THE DEVICE. THE FACILITY OPENED A NEW PRODUCT (UNKNOWN MAKE AND MODEL) TO COMPLETE THE INTENDED PROCEDURE. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6568649 ↗