INFINITI CP0210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032025942), received between Nov 11, 2024 and Nov 11, 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 16, 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.

• MalfunctionNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE CURVE OF A 6F PIGTAIL INFINITI DIAGNOSTIC CATHETER WITHIN A CUSTOMIZED 6F INFINITY DIAGNOSTIC CATHETER MULTIPACK CAME OFF. AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT. FOR EVALUATION. THE DEVICE WAS NOT IN TOUCH WITH THE PATIENT AND THERE WERE NO REPORTED PATIENT INJURIES. THERE WAS NO APPARENT DAMAGE WHEN UNPACKING THE CATHETER AND THE DEVICE WAS PLACED AT THE TABLE. WHEN THE PHYSICIAN PICKED UP THE DEVICE TO BE USED, THE DISTAL TIP CAME OFF. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THE MULTIPACK INCLUDED A PIG-TAIL CATHETER, A JUDKINS LEFT (JL) CATHETER AND A JUDKINS RIGHT (JR) CATHETER. THE PIGTAIL WAS THE ONLY CATHETER WITH ISSUES. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652156 ↗

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