INFINITI 534645TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032014335), received between Mar 31, 2025 and Nov 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Degraded” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, THE PLASTIC AROUND THE CATHETER HUB OF A 6F JUDKIN¿S RIGHT (JR) 4 100CM THRULUMEN (TL) INFINITI DIAGNOSTIC CATHETER DISINTEGRATED WITHIN THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THIS ISSUE HAS REPORTEDLY OCCURRED THREE TIMES, INVOLVING THREE SEPARATE CATHETERS. THE STAFF OBSERVED THE CONDITION WHILE STOCKING SHELVES; THE AFFECTED CATHETERS WERE NOT USED ON PATIENTS. THE REPORTER NOTED THAT THE ONLY DIFFERENCE IDENTIFIED IN THE LABORATORY WAS THE USE OF AN ULTRAVIOLET (UV) LIGHT SYSTEM USED TO STERILIZE THE ROOM AFTER CASES. THE DEVICES WERE STORED HANGING IN A CABINET WITH GLASS DOORS THAT INCLUDE BUILT-IN ULTRAVIOLET (UV) STERILIZING LIGHTS. OTHER CORDIS CATHETERS STORED IN THE SAME ENVIRONMENT REPORTEDLY EXHIBITED SIMILAR ISSUES, WHILE OTHER NON-CORDIS CATHETERS DID NOT. THE DEVICES REMAINED IN THEIR WHITE OUTER BOXES UNTIL USE AND WERE NOT REPROCESSED OR RESTERILIZED. THE LABORATORY ROUTINELY USES UV STERILIZATION AND OZONE DISINFECTION DAILY, INCLUDING IN PROCEDURE ROOMS. THE DEVICE PACKAGING REPORTEDLY SHOWED HUB FLAKING PRIOR TO OPENING. DETAILS REGARDING THE SUPPLIER OF THE UV LIGHTING ARE NOT CURRENTLY AVAILABLE. THE THREE DEVICES WILL BE RETURNED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509543 ↗
• MalfunctionAug 5, 2025Degraded; Degraded

  AS REPORTED, A NEW AND UNUSED 6F TL AL I 100 CM INFINITI DIAGNOSTIC CATHETER WAS FOUND WITH FLAKES INSIDE THE PACKAGE, AS IF THE PLASTIC OR COATING HAD DISINTEGRATED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER THAT WAS SENT IN FOR REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE DAMAGES FOUND ON THE DEVICE PRIOR TO OPENING, BUT NONE ON THE DEVICE PACKAGING. THE ISSUE WAS IDENTIFIED DURING PRE-USE INSPECTION. THE DEVICE WAS STORED IN A HYBRID ROOM IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716054 ↗
• MalfunctionMar 31, 2025Degraded; Degraded

  AS REPORTED, MULTIPLE NEW/UNUSED INFINITI GUIDE CATHETERS HAD FLAKES INSIDE THE PACKAGE. AS IF THE PLASTIC OR COATING DISINTEGRATED. THE FLAKING APPEARS TO BE RIGHT BELOW THE HUB OF THE DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICES ARE STORED WITHIN THE CATH LAB RACK. THE DEVICE IS EXPOSED TO NORMAL LIGHT AND UV SANITIZING LIGHT AFTER A CASE WHEN STORED. THE DEVICES ARE NOT STORED IN THE WHITE OUTER BOX UNTIL THEY ARE USED. THEY ARE STORED IN CABINETS WITH TRANSPARENT GLASS DOORS. THE SHIPMENT OF DEVICES IS STORED DIRECTLY IN THE CATH LAB AND IS NOT EXPOSED TO A NON-CLIMATE-CONTROLLED ENVIRONMENT BEFORE BEING STORED IN THE LAB. THE DEVICE IS NOT REPROCESSED OR RE-STERILIZED. THE DEVICE IS EXPOSED TO UV LIGHTING AS PART OF THE STERILIZATION PROCESS. THE LAB USES UV OR OTHER STERILIZATION PROCESSES IN GENERAL. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731343 ↗

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