INFINITI 534648TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032014366), received between Dec 22, 2021 and Mar 31, 2025 — classified as 2 malfunctions.

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

• 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 21731370 ↗
• MalfunctionDec 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHILE ATTEMPTING TO ADVANCE A 6F INFINITY TL AR MOD 100CM DIAGNOSTIC CATHETER, THE 0.035 J WIRE KINKED AND WHEN THE CATHETER WAS PULLED BACK INTO THE RADIAL ARTERY, THE DISTAL TIP OF THE CATHETER SEPARATED/BROKE APPROXIMATELY 4 INCHES FROM THE DISTAL END OF THE DEVICE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A CUT DOWN PROCEDURE WAS DONE. THE PATIENT WAS STATED TO BE IN GOOD CONDITION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THE INTENDED PROCEDURE WAS A LEFT SIDED HEART CATHETERIZATION WITH A RADIAL ACCESS SITE. THERE WAS NO CALCIFIED LESION, OR TORTUOSITY. THERE WAS NO VESSEL ANGULATION, NO STENOSIS OR CHRONIC TOTAL OCCLUSION. THE DEVICE WAS NOT RE-STERILIZED. THERE WAS RESISTANCE MET WHILE ADVANCING THE DEVICE, AND EXCESSIVE TORQUING WAS REQUIRED. RESISTANCE WAS MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE KINKED IN THE AREA OF SEPARATION. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060127 ↗

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