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TriForce G56413Recalls & reported problems

Cook Incorporated · TriForce Peripheral Crossing Set · Class 2

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 00827002564138), received between May 29, 2018 and Nov 5, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Device problems

  • Fluid/Blood Leak1
  • Split1
  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 5, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED, THE OUTER SHEATH OF A TRIFORCE PERIPHERAL CROSSING SET CAME OUT OF THE PLASTIC CASE AND PUNCTURED THE PEEL AWAY PACKAGING, RENDERING IT NON-STERILE. THE PRODUCT WAS PART OF THE SALES REP STOCK, SO NO PATIENT WAS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

    MAUDE report 10794626 ↗
  • MalfunctionOct 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

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

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9167946 ↗
  • MalfunctionMay 29, 2018Split; Split

    IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND, VIA THE ILIAC VEIN, THE TRIFORCE¿ PERIPHERAL CROSSING SET BEGAN TEARING AT THE TIP UPON REMOVAL FROM THE PATIENT'S ANATOMY. ACCORDING TO THE COMPLAINANT, THE COMPLAINT DEVICE REMOVAL WAS NOT DIFFICULT AND NO PORTION REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER TYPE OF DEVICE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7550163 ↗

Other Catheter, continuous flush devices

All Catheter, continuous flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.