TriForce G56416Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002564169), received between Oct 23, 2019 and Nov 14, 2024 — classified as 1 injury, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 05NOV2019 NOTING THAT THE PROCEDURE BEING PERFORMED WAS A CHRONIC ILIOFEMORAL OUTFLOW OBSTRUCTION. THE FLEXOR SHEATH SPLIT WHILE TRYING TO CROSS THE LESION. REPORTEDLY, THE PHYSICIAN NOTED THAT THERE WAS ONE LOCATION WHERE HE WAS TRYING TO CROSS AND "YOU COULD SEE THE FLEXOR TIP GET 'HUNG UP' ON THE LESION". ADDITIONALLY, RESISTANCE DURING INSERTION OR RESISTANCE WAS NOT NOTED. PRIOR TO USE, THE SHEATH WAS ADEQUATELY PREPPED AND FLUSHED, AND THE HYDROPHILIC COATING WAS ACTIVATED. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY OTHER COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9225286 ↗