INFINITI 555500T1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032079303), received between Aug 26, 2024 and Aug 26, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN THE PHYSICIAN AIMED TO INSERT AND SHAPE THE 5F 100CM, RBL-TG 1 SIDE HOLE (SH) INFINITI DIAGNOSTIC CATHETER, IT BECAME DETACHED AND COULD NOT BE USED AT ALL. THERE WERE NO REPORTS OF PATIENT INJURY. THIS EVENT OCCURRED DURING PREP. FOUR CATHETERS ARE BEING RETURNED. THE DEVICES WERE STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), AND A CONTRALATERAL APPROACH WAS NOT USED. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB, BUT IT WAS NOT TORQUED OR "STEERED" BY THE HUB. THE CATHETER DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE. A TOTAL OF FOUR (4) CATHETERS WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071155 ↗

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