TriForce G56417Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002564176), received between Aug 10, 2016 and Oct 30, 2024 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING A THROMBECTOMY AND VENOUS STENT PLACEMENT VIA IPSILATERAL ACCESS, THE TIP OF A TRIFORCE PERIPHERAL CROSSING SET¿S SHEATH SPLIT AND SEPARATED WHILE TRYING TO CROSS A STENOSED AND VERY THROMBOTIC CHRONIC VENOUS OCCLUSION. THE PATIENT REPORTEDLY HAD A LARGE AMOUNT OF THROMBUS BURDEN, AND RESISTANCE WAS ENCOUNTERED WHILE TRYING TO ADVANCE THE DEVICE THROUGH THE LESION. THE SEPARATED FRAGMENT WAS RETRIEVED FROM THE VEIN DURING THE SAME PROCEDURE, USING A SUCTION THROMBECTOMY CATHETER. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570897 ↗
• MalfunctionMay 6, 2024Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING RECANALIZATION OF A CENTRAL VEIN, A TRIFORCE PERIPHERAL CROSSING SET¿S SHEATH SEPARATED AT THE TUNGSTEN TIP. AFTER THE DEVICE¿S HYDROPHILIC COATING WAS ACTIVATED, ACCESS WAS OBTAINED IN THE RIGHT BRACHIAL VEIN TO TARGET THE PROXIMAL SUBCLAVIAN VEIN. THE ANATOMY WAS NORMAL. THE WIRE TIP WAS EXTENDED PAST THE CATHETER TIP AT ALL TIMES, AND THE CATHETER TIP WAS EXTENDED PAST THE SHEATH TIP AT ALL TIMES. THE SYSTEM WAS ADVANCED IN STEPWISE, SHORT ADVANCES OF THE WIRE GUIDE, CATHETER, AND SHEATH. WHILE ATTEMPTING TO CROSS THE LESION, THE SHEATH TIP ¿SNAPPED¿ WITHIN THE FIRST FEW MILLIMETERS, AT THE NATURAL BEND OF THE STENOTIC VEIN. PER THE REPORTER, ¿QUITE A BIT¿ OF FORCE WAS APPLIED WHILE TRYING TO CROSS THE LESION. THE CATHETER AND SHEATH WERE REMOVED OVER THE WIRE GUIDE AFTER THE SHEATH TIP SEPARATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER COOK SHEATH AND THE ORIGINAL CATHETER. AN ANGIOPLASTY BALLOON WAS THEN USED THROUGH THE STRICTURE TO ALLOW PASSAGE OF LARGER BALLOONS AND A 5-FRENCH SHEATH. THE USER NOTED EVIDENCE OF A FOCAL LESION WHEN LARGER UNKNOWN BALLOONS WERE USED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255382 ↗
• MalfunctionMay 6, 2024Break; Unraveled Material; Break; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255295 ↗
• InjuryJan 31, 2024Break; Break

  AS REPORTED, DURING TRANSLUMINAL ANGIOPLASTY OF THE LOWER LIMBS, THE TIP OF A TRIFORCE PERIPHERAL CROSSING SET'S SHEATH SEPARATED AND REMAINS IN THE PATIENT. ACCESS WAS OBTAINED IN THE SUPERFICIAL FEMORAL ARTERY TO TARGET A VERY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED. BECAUSE THE LESION WAS VERY CALCIFIED, PROGRESSION OF AN UNSPECIFIED GUIDE WAS DIFFICULT, AND IT WAS DIRECTED TOWARD THE SUBINTIMAL SPACE. THE USER ATTEMPTED TO "RETURN TO THE LIGHT" WITH A CXI CATHETER; HOWEVER, THIS WAS UNSUCCESSFUL. THE CXI CATHETER REPORTEDLY DID NOT MALFUNCTION, BUT WOULD NOT CROSS THE VERY CALCIFIED LESION. A COOK WIRE GUIDE, USED DURING THE PROCEDURE, DID NOT MALFUNCTION. THE USER THEN CHANGED THE PUNCTURE SITE AND OBTAINED ACCESS MEDIAL TO THE LIMB IN AN ATTEMPT TO CROSS THE LESION, WITHOUT MAJOR PROGRESSION. THE COMPLAINT DEVICE WAS THEN USED, WHICH PROGRESSED A "LITTLE MORE" THAN WITH OTHER ATTEMPTS; HOWEVER, THE GUIDE ALWAYS LED TO THE SUBINTIMAL SPACE. A POWER INJECTOR WAS USED DURING THE PROCEDURE. DURING THE ATTEMPTS TO ADVANCE THE COMPLAINT DEVICE, THE RADIOPAQUE TIP OF THE SHEATH SEPARATED. THE SEPARATED TIP REMAINS IN THE PATIENT. TH

  Patient problems: Foreign Body In Patient

  MAUDE report 18619105 ↗
• InjuryAug 24, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17618521 ↗
• InjuryAug 4, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  AS REPORTED, DURING A PROCEDURE INVOLVING AN ANGIOPLASTY OF THE RIGHT LOWER LIMB, THE TIPS SEPARATED FROM A TRIFORCE PERIPHERAL CROSSING SET'S CATHETER AND SHEATH. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TARGET THE SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE BIFURCATION WAS "SLIGHTLY ANGLED" AND CALCIUM PLAQUES WERE REPORTED ALONG THE ENTIRE LENGTH OF THE STENOSED SUPERFICIAL FEMORAL ARTERY. ALTHOUGH RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE COMPLAINT DEVICE, RESISTANCE WAS ENCOUNTERED DURING INSERTION AND REMOVAL OF OTHER DEVICES THROUGH THE SHEATH AT THE LOCATION OF THE CALCIFIED ANATOMY. A POWER INJECTOR WAS NOT USED DURING THE PROCEDURE. AS THE DEVICE WAS PASSED THROUGH THE LESION, THE CATHETER TIP SEPARATED. AS THE TRIFORCE COAXIAL SYSTEM WAS REMOVED FROM THE PATIENT, THE USER NOTED THAT THE SHEATH TIP WAS ALSO DAMAGED. PHOTOS PROVIDED BY THE CUSTOMER APPEAR TO SHOW SHEATH TIP SEPARATION AND POSSIBLE SHEATH DELAMINATION. THE CATHETER TIP REMAINS IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY; HOWEVER, RADIOLOGIC IMAGING DID NOT IDENTIFY ANY SHEATH MATERIAL LEFT IN THE PATIENT. AN UNSPEC

  Patient problems: Foreign Body In Patient

  MAUDE report 17460614 ↗
• MalfunctionSep 9, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING RE-CANNULATION OF THE LEFT COMMON FEMORAL AND LEFT COMMON ILIAC VEINS, THE HUB SEPARATED FROM A TRIFORCE PERIPHERAL CROSSING SET'S CATHETER. ACCESS WAS OBTAINED IN THE LEFT POPLITEAL VEIN. THE LEFT COMMON FEMORAL AND COMMON ILIAC VEINS WERE OCCLUDED AND STENTS HAD BEEN PREVIOUSLY PLACED. DURING MANIPULATION OF THE DEVICE BY TWISTING THE CATHETER, IN ORDER TO CROSS THE OCCLUDED PORTION OF THE VESSEL, THE HUB REPORTEDLY "SPUN OFF". 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 12450473 ↗
• MalfunctionFeb 1, 2021Crack; Crack

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A TRIFORCE PERIPHERAL CROSSING SET WAS USED TO CROSS A VENOUS LESION. THE INNER CXI CATHETER WAS REMOVED, LEAVING AN UNKNOWN WIRE GUIDE IN PLACE. THE USER FLUSHED THROUGH THE SIDE PORT OF THE OUTER CATHETER AND THE HUB CRACKED, LEAVING A SMALL PIECE IN THE SYRINGE. THE INNER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. 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; No Consequences Or Impact To Patient

  MAUDE report 11259472 ↗
• MalfunctionFeb 4, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OCCLUSION OF THE LEFT COMMON ILIAC VEIN, A TRIFORCE PERIPHERAL CROSSING SET CATHETER SPLIT. AT THE BEGINNING OF THE PROCEDURE, AN UNSPECIFIED COOK 0.035 INCH ROADRUNNER WIRE GUIDE WAS PLACED IN THE LEFT SAPHENOUS VEIN THROUGH THE 14FR 15CM TRIFORCE SHEATH. DURING ADVANCEMENT OF THE SHEATH, THE SHEATH WOULD NOT FOLLOW ALONG THE CATHETER ALREADY PRESENT IN THE OCCLUSION. IT WAS FOUND, VIA FLUOROSCOPY, THAT THE TIP OF THE CATHETER HAD PARTIALLY SPLIT DOWN THE SIDE. THE CATHETER WAS ABLE TO BE REMOVED THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN CATHETER AND WITHOUT THE SHEATH. THE ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR CALCIFIED. THE PATIENT'S OUTCOME WAS REPORTED AS "GOOD." UPON INITIAL EVALUATION OF THE DEVICE ON 03FEB2020, THE CATHETER WAS SPLIT ON BOTH SIDES. 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 9665114 ↗
• MalfunctionJan 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A VENOGRAM, A TRIFORCE PERIPHERAL CROSSING SET HUB SEPARATED FROM THE CATHETER. BOTH JUGULAR AND FEMORAL VEINS WERE ACCESSED. THE PATIENT'S ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR CALCIFIED. THE DEVICE WAS NOT USED WITH A POWER INJECTOR. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED OR AT WHAT POINT IN THE PROCEDURE THE HUB SEPARATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER OF THE SAME DEVICE AND A VENOUS STENT WAS PLACED. 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. DURING THE SAME PROCEDURE, THE TIP OF ANOTHER TRIFORCE PERIPHERAL CROSSING SET SHEATH SEPARATED IN THE PATIENT. THIS EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538480 ↗
• MalfunctionAug 10, 2016Material Separation; Material Separation

  THE DEVICE BROKE AND WASN'T EVEN BEING TOUCHED WHILE CROSSING A VENOUS OCCLUSION PROCEDURE. WHEN THE USER WENT TO REMOVE IT FROM THE PATIENT'S ACCESS SITE, THE DEVICE CAME APART BETWEEN THE HEMOSTATIC VALVE AND SHEATH. NO INSTRUMENTS WERE USED TO REMOVE THE DEVICE. INFORMATION WAS PROVIDED THAT YOU CAN SEE THE WIRE. THE WHITE CONNECTOR STILL HAS THE A PIECE OF CATHETER IN IT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5865518 ↗