INFINITI 534543TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032013833), received between Sep 27, 2019 and Sep 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED, TWO 5F INFINITI CATHETERS WERE EXPIRED BY THE TIME THEY WERE USED IN SURGERY. THIS WAS NOTICED AFTER THE PROCEDURE WAS DONE WHEN THE PATIENT FILE WAS BEING PREPARED. THE PHYSICIAN NOTICED THAT THE LABEL WAS MODIFIED, SPECIFICALLY IN THE EXPIRATION DATE. WHEN THE COAS WAS REVIEWED, THE PRODUCT WAS NOTED TO HAVE BEEN EXPIRED 2 YEARS BEFORE (2017) AND THE DATE QUOTED WAS (B)(6) 2019. THERE WAS N REPORTED PATIENT INJURY. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA). AFTER THE PRODUCT WAS USED AND IMPLANTED IN THE PATIENT IT WAS REALIZED THAT THE PRODUCT HAD AN EXPIRED DATE. THERE WAS NOT OUTER BOX. THERE WERE ONLY TWO (2) CATHETERS. THERE WAS NO ILLEGIBLE PRINTING OF THE DATE, BUT IT WAS INCONSISTENT REGARDING FONT AND SIZE. THE PRODUCT INVENTORY IS MANAGED AT CATH LAB, FIRST IN FIRST OUT (FIFO). THE FACILITY PLACES IT EASIER TO HAND IN THEIR INVENTORIES. THE CATH LAB TEAM COLLECTS THE LABEL FROM EVERY USED DEVICE. A NON-VERY COMMON CURVE OR SIZE (CATHETER TYPE), MAY BE CONSIDERED A NEGLECT OR HECTIC SCHEDULE. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130803 ↗
• MalfunctionSep 27, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED, TWO 5F INFINITI CATHETERS WERE EXPIRED BY THE TIME THEY WERE USED IN SURGERY. THIS WAS NOTICED AFTER THE PROCEDURE WAS DONE WHEN THE PATIENT FILE WAS BEING PREPARED. THE PHYSICIAN NOTICED THAT THE LABEL WAS MODIFIED, SPECIFICALLY IN THE EXPIRATION DATE. WHEN THE COAS WAS REVIEWED, THE PRODUCT WAS NOTED TO HAVE BEEN EXPIRED 2 YEARS BEFORE (2017) AND THE DATE QUOTED WAS (B)(6) 2019. THERE WAS N REPORTED PATIENT INJURY. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA). AFTER THE PRODUCT WAS USED AND IMPLANTED IN THE PATIENT IT WAS REALIZED THAT THE PRODUCT HAD AN EXPIRED DATE. THERE WAS NOT OUTER BOX. THERE WERE ONLY TWO (2) CATHETERS. THERE WAS NO ILLEGIBLE PRINTING OF THE DATE, BUT IT WAS INCONSISTENT REGARDING FONT AND SIZE. THE PRODUCT INVENTORY IS MANAGED AT CATH LAB, FIRST IN FIRST OUT (FIFO). THE FACILITY PLACES IT EASIER TO HAND IN THEIR INVENTORIES. THE CATH LAB TEAM COLLECTS THE LABEL FROM EVERY USED DEVICE. A NON-VERY COMMON CURVE OR SIZE (CATHETER TYPE), MAY BE CONSIDERED A NEGLECT OR HECTIC SCHEDULE. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130773 ↗

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