INFINITI 534652SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705032014403), received between Mar 31, 2025 and May 26, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, BOX OF 6F INIFINTI PIGTAIL 145 ANGLE 110CM DIAGNOSTIC CATHETERS WERE DAMAGED WHEN THEY WERE DELIVERED. THE STERILITY OF THE DEVICES WERE COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY. THE BOXES WERE DAMAGED. THE DAMAGE WAS NOTED UPON THE INITIAL RECEIPT OF THE PRODUCT. THE DEVICES WERE NOT USED. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085266 ↗
• MalfunctionMay 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, BOX OF 6F INIFINTI PIGTAIL 145 ANGLE 110CM DIAGNOSTIC CATHETERS WERE DAMAGED WHEN THEY WERE DELIVERED. THE STERILITY OF THE DEVICES WERE COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY. THE BOXES WERE DAMAGED. THE DAMAGE WAS NOTED UPON THE INITIAL RECEIPT OF THE PRODUCT. THE DEVICES WERE NOT USED. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085265 ↗
• MalfunctionMay 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, BOX OF 6F INIFINTI PIGTAIL 145 ANGLE 110CM DIAGNOSTIC CATHETERS WERE DAMAGED WHEN THEY WERE DELIVERED. THE STERILITY OF THE DEVICES WERE COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY. THE BOXES WERE DAMAGED. THE DAMAGE WAS NOTED UPON THE INITIAL RECEIPT OF THE PRODUCT. THE DEVICES WERE NOT USED. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085264 ↗
• MalfunctionMay 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, BOX OF 6F INIFINTI PIGTAIL 145 ANGLE 110CM DIAGNOSTIC CATHETERS WERE DAMAGED WHEN THEY WERE DELIVERED. THE STERILITY OF THE DEVICES WERE COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY. THE BOXES WERE DAMAGED. THE DAMAGE WAS NOTED UPON THE INITIAL RECEIPT OF THE PRODUCT. THE DEVICES WERE NOT USED. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085263 ↗
• MalfunctionMay 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, BOX OF 6F INIFINTI PIGTAIL 145 ANGLE 110CM DIAGNOSTIC CATHETERS WERE DAMAGED WHEN THEY WERE DELIVERED. THE STERILITY OF THE DEVICES WERE COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY. THE BOXES WERE DAMAGED. THE DAMAGE WAS NOTED UPON THE INITIAL RECEIPT OF THE PRODUCT. THE DEVICES WERE NOT USED. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085261 ↗
• 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 21731323 ↗

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