INFINITI 534560TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032013963), received between Jan 23, 2024 and Sep 17, 2025 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Degraded; Degraded

  AS REPORTED, BLUE PIECES AND CRACKING OF PLASTIC NEAR THE HUB WERE FOUND ON MULTIPLE DIAGNOSTIC CATHETERS, INCLUDING 5F JL3.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-518T), 5F JL4 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-520T), 5F JL4.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-517T), 5F IM SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-560T), AND A 5.2F MP A2(I) 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER (CATALOG NUMBER 533-556). THE AFFECTED PRODUCTS WERE IDENTIFIED ACROSS MULTIPLE PACKAGES DURING STOCK INSPECTION, AND THE PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE DEVICES WILL BE RETURNED FOR EVALUATION. FOUR IMAGES WERE REVIEWED AND THE SHOW CATHETERS INSIDE THEIR PACKAGING. POLYMER FLAKES CAN BE SEEN INSIDE THE PACKAGING, AND THEY APPEAR TO HAVE ORIGINATED FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23079212 ↗
• MalfunctionSep 17, 2025Degraded; Degraded

  AS REPORTED, BLUE PIECES AND CRACKING OF PLASTIC NEAR THE HUB WERE FOUND ON MULTIPLE DIAGNOSTIC CATHETERS, INCLUDING 5F JL3.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-518T), 5F JL4 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-520T), 5F JL4.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-517T), 5F IM SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-560T), AND A 5.2F MP A2(I) 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER (CATALOG NUMBER 533-556). THE AFFECTED PRODUCTS WERE IDENTIFIED ACROSS MULTIPLE PACKAGES DURING STOCK INSPECTION, AND THE PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE DEVICES WILL BE RETURNED FOR EVALUATION. FOUR IMAGES WERE REVIEWED AND THE SHOW CATHETERS INSIDE THEIR PACKAGING. POLYMER FLAKES CAN BE SEEN INSIDE THE PACKAGING, AND THEY APPEAR TO HAVE ORIGINATED FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077615 ↗
• MalfunctionSep 17, 2025Degraded; Degraded

  AS REPORTED, BLUE PIECES AND CRACKING OF PLASTIC NEAR THE HUB WERE FOUND ON MULTIPLE DIAGNOSTIC CATHETERS, INCLUDING 5F JL3.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-518T), 5F JL4 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-520T), 5F JL4.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-517T), 5F IM SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-560T), AND A 5.2F MP A2(I) 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER (CATALOG NUMBER 533-556). THE AFFECTED PRODUCTS WERE IDENTIFIED ACROSS MULTIPLE PACKAGES DURING STOCK INSPECTION, AND THE PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE DEVICES WILL BE RETURNED FOR EVALUATION. FOUR IMAGES WERE REVIEWED AND THE SHOW CATHETERS INSIDE THEIR PACKAGING. POLYMER FLAKES CAN BE SEEN INSIDE THE PACKAGING, AND THEY APPEAR TO HAVE ORIGINATED FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077471 ↗
• MalfunctionJan 23, 2024Crack; Crack

  AS REPORTED, A 5F INFINITI INTERNAL MAMMARY 100CM CATHETER WAS FRACTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563119 ↗

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