INFINITI 534676TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032014489), received between May 4, 2018 and Oct 20, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K970854); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Crack; Crack

  AS REPORTED, THE TIP OF A 6F 100 CM 3DRC INFINITI DIAGNOSTIC CATHETER FRACTURED WHILE A .035-INCH WIRE WAS BEING INTRODUCED THROUGH THE CATHETER. THE CATHETER DID NOT BECOME ENTRAPPED, AND THERE WAS NO DEVICE SEPARATION. A SECOND 3DRC INFINITI CATHETER WAS USED TO COMPLETE THE ANGIOGRAPHY PROCEDURE, AND A CONTRALATERAL APPROACH WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE IN THE CATHETER PACKAGING. THE PRODUCT WAS STORED ON THE SHELF IN THE CATH. LAB AND OPENED IN STERILE FIELD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO KINK IN THE DISTAL OF THE CATHETER WAS REMARKED. THE DEVICE DAMAGE WAS NOT NOTICED ONCE THE CATHETER WAS OPENED FROM THE PACKAGING. NO FORCE WAS APPLIED BECAUSE THE CATHETER DID NOT INTRODUCE THROUGH THE SHEATH. AT THE TARGET SITE, THE VESSEL WAS NON-CALCIFIED, MILDLY TORTUOUS, NON-BIFURCATING, AND THE STENOSIS PERCENTAGE AND PRESENCE OF AN ACUTE ANGLE WERE NOT AVAILABLE. AT THE ACCESS SITE, THE VESSEL WAS NEITHER CALCIFIED NOR TORTUOUS, AND DETAILS ON STENOSIS PERCENTAGE, ACUTE ANGLE, AND BIFURCATION WERE NOT AVAILABLE. THE DEVICE WAS NEITHER PULLED FROM THE PACKAGING BY THE HUB NOR TORQUED/STEERED BY THE HUB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335438 ↗
• MalfunctionMay 4, 2018Crack; Crack

  BEFORE USE, THE TIP OF THE 6F INFINITI CATHETER WAS NOT ATTACHED AND WAS HANGING BY A PIECE OF PLASTIC. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7487688 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970854. One submission often covers many models, so check the product and lot details in each record.

• Z-0286-2024 · Sep 26, 2023 · Open, Classified
  Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
• Z-0720-2023 · Nov 7, 2022 · Open, Classified
  Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
• Z-1240-06 · Jun 26, 2006 · Terminated
  Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T