INFINITI 534622TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032014205), received between Aug 10, 2021 and Mar 31, 2025 — classified as 3 malfunctions.

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

• MalfunctionMar 31, 2025Degraded; Degraded

  AS REPORTED, DURING INVENTORY REVIEW, A STAFF MEMBER NOTICED THAT THE UN-OPENED F6 INFINITI JL 5 DIAGNOSTIC CATHETER HAD A SIGNIFICANT AMOUNT OF BLUE COLORED PARTICLES SPRINKLED ALL THROUGHOUT THE INSIDE OF THE UNOPENED PACKAGE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE HAS NOT BEEN REMOVED FROM ITS PACKAGE, SO NO OBSERVATIONS OF FLAKING COULD BE MADE. IT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICES ARE HUNG ON A HOOK IN THE CATH LAB AND RECEIVED NO DIRECT SUNLIGHT EXPOSURE, ONLY INDIRECT EXPOSURE TO NORMAL CATH LAB LIGHTING. THEY ARE NOT STORED IN THE WHITE OUTER BOX UNTIL USE BUT ARE KEPT IN CABINETS WITH TRANSPARENT OR DARK DOORS. THE SHIPMENT OF DEVICES WAS ALWAYS STORED IN A CLIMATE-CONTROLLED ENVIRONMENT BEFORE BEING PLACED IN THE LAB. THE DEVICE HAS NOT BEEN REPROCESSED OR RE-STERILIZED AND REMAINS IN ITS ORIGINAL CORDIS PACKAGING. IT HAS NOT BEEN EXPOSED TO UV LIGHTING OR ANY FORM OF STERILIZATION PROCESS AT ANY POINT. THE LAB DOES NOT USE ANY UV OR STERILIZATION PROCESSES IN GENERAL. OTHER DEVICES IN THE BOX WERE NOT EXAMINED, AS NO OTHER DEVICES WITH THIS LOT NUMBER REMAINED IN THE INVENTORY. THE DEVICE WILL BE RETURNED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729871 ↗
• MalfunctionMay 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6F JUDKINS LEFT 5 INFINITI DIAGNOSTIC CATHETER BROKE OFF AT THE PROXIMAL BEND UPON INSERTING INTO A NON-CORDIS SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE SEPARATED IN PATIENT. THE DEVICE WAS PULLED INTO THE SHEATH AND SEPARATED ONCE IN SHEATH. THE SHEATH WAS REMOVED WITH THE PIECE INTACT. THE PATIENT RECENTLY HAD AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND THE OPERATOR OF THE DEVICE BELIEVES THE STENT-GRAFT MAY HAVE NOT BEEN FULLY ENDOTHELIALIZED, WHICH COULD HAVE CAUSED A CUT ON THE CATHETER THAT CAUSED IT TO BREAK. THE PRODUCT WAS STORED PROPERLY AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. A CONTRALATERAL APPROACH WAS NOT USED. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB AND SHAFT OF CATHETER. THE VESSEL WAS NOT ENGAGED DUE TO THE ISSUE EXPERIENCED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE CATHETER DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE. EXCESSIVE TORQUING WAS NOT REQUIRED. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE PROCEDURE ENDED BECAUSE OF CATHETER SEPARATION. THERE WAS NO INJURY TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928420 ↗
• MalfunctionAug 10, 2021Crack; Crack

  A 6F 100CM JL 5 INFINITI THRULMEN DIAGNOSTIC CATHETER HAD A CRACK IN THE DISTAL END AND WAS IT WAS NOTICED WHEN DEVICE WAS BEING PREPPED FOR USE. THE DEVICE NEVER ENTERED THE PATIENT, AND NO HARM WAS CAUSED. IT WAS INITIALLY REPORTED "WIRE LOOKS LIKE IT WAS DAMAGE DURING MANUFACTURING. THERE IS A SNIP OUT IF IT NEAR THE J END." THIS PRODUCT DOES NOT CONTAIN A WIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION. 3 IMAGES WERE PROVIDED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301758 ↗

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