TriForce G56419Recalls & reported problems
Cook Incorporated · TriForce Peripheral Crossing Set · Class 2
All models of TriForce (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002564190), received between Dec 4, 2020 and Jul 28, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionDec 4, 2020Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10945762 ↗
Other Catheter, continuous flush devices
- PROWLER SELECT 606-S255XMedos International Sàrl · Catheter, continuous flush2 deaths980 reports
- PhenomTM 27 Catheter FG15150-0615-1SMicro Therapeutics, Inc. · Catheter, continuous flush2 deaths139 reports
- MarathonTM 105-5056Micro Therapeutics, Inc. · Catheter, continuous flush124 reports
- MarksmanTM FA-55150-1030Micro Therapeutics, Inc. · Catheter, continuous flush109 reports
- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · Catheter, continuous flush109 reports
- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page