TriForceRecalls & reported problems across all models
Cook Incorporated · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 6 models of TriForce by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2016 and Sep 3, 2025 — classified as 4 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TriForce problems
Device problems
- Break11
- Material Separation4
- Material Split, Cut or Torn3
- Peeled/Delaminated3
- Unraveled Material3
- Detachment of Device or Device Component2
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient6
- Foreign Body In Patient3
- No Known Impact Or Consequence To Patient3
- No Patient Involvement2
- Insufficient Information1
TriForce models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TriForce G56417Catheter, continuous flush11 reports
- TriForce G56416Catheter, continuous flush4 reports
- TriForce G56413Catheter, continuous flush3 reports
- TriForce G56415Catheter, continuous flush3 reports
- TriForce G56419Catheter, continuous flush3 reports
- TriForce G56412Catheter, continuous flush1 report
Recent TriForce adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJul 28, 2025Break; Break
AS REPORTED, DURING A VENOUS INTERVENTION PROCEDURE, THE TIP OF A TRIFORCE PERIPHERAL CROSSING SET BROKE. PER THE REPORTER, THE USER WAS ATTEMPTING TO CROSS A TIGHT STENOSIS/OCCLUSION, AND RESISTANCE WAS ENCOUNTERED DUE TO THE DIFFICULT ANATOMY. AS THE SHEATH WAS PULLED BACK, THE TIP BROKE. THE DEVICE WAS REMOVED MANUALLY WITH THE SHEATH. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631336 ↗MalfunctionNov 14, 2024Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 13NOV2024 AND INADVERTENTLY OMITTED FROM THE INITIAL REPORT. THE BREAK/UNRAVELING WAS NOTED AFTER SUCCESSFUL USE AND REMOVAL OF THE DEVICE, PER THE INSTRUCTIONS FOR USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT INCIDENT. 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. NO ADDITIONAL INFORMATION WILL BE PROVIDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20682832 ↗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 ↗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 ↗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 ↗MalfunctionJan 15, 2024Break; Break
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 18512665 ↗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 ↗InjuryMay 24, 2023Break; Break
AS REPORTED, DURING THE MIDDLE OF A PROCEDURE INVOLVING RECONSTRUCTION OF THE INFERIOR VENA CAVA, VIA ACCESS IN THE FEMORAL ARTERY, THE TIP BROKE OFF OF A TRIFORCE PERIPHERAL CROSSING SET'S SHEATH. THE SEPARATED TIP WAS BALLOONED INTO THE SHEATH AND REMOVED FROM THE PATIENT SUCCESSFULLY. SCISSORS WERE THEN USED TO REMOVE THE ENCAPSULATED BROKEN TIP. THERE HAS BEEN NO REPORT OF ANY ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16992546 ↗MalfunctionSep 22, 2021Material Separation; Material Separation
AS REPORTED, DURING A VENOUS OCCLUSION PROCEDURE THE TIP OF A TRIFORCE¿ PERIPHERAL CROSSING SET SHEARED WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THE PATIENT IS DOING WELL. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12511939 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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