INFINITI 534542TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032013826), received between Jul 24, 2025 and Jul 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJul 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, FIVE (5) BOXES OF 5F JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETERS AND TWO (2) BOXES OF 5F MULTIPURPOSE A MPA 2 SH (2 SIDE HOLES) INFINITI CATHETERS WERE FOUND TO BE DAMAGED. NO PATIENT INJURIES WERE REPORTED. THE DAMAGE OCCURRED DURING TRANSPORT AND AFFECTED MULTIPLE LEVELS OF PACKAGING AS WELL AS THE PRODUCTS THEMSELVES. SPECIFICALLY, THE SHIPPING BOX AND OUTER PRODUCT BOXES WERE DAMAGED. THE INNER PRODUCT POUCHES WERE ALSO PUNCTURED FROM THE OUTSIDE, AND THE STERILE POUCHES WERE RECEIVED WITH PUNCTURES; HOWEVER, THE SEALS REMAINED INTACT. THE PRODUCTS WERE NOT STORED IN THE LAB AND HAD NOT BEEN BROUGHT INTO THE LAB PRIOR TO THE DISCOVERY OF THE DAMAGE. THE ACTUAL DEVICES WERE ALSO COMPROMISED, EXHIBITING KINKS THAT RENDER THEM UNSUITABLE FOR USE IN PROCEDURES. AN IMAGE WAS PROVIDED SHOWING MULTIPLE OUTER BOXES OF DIAGNOSTIC CATHETERS INSIDE A SHIPPING CONTAINER, SEVERAL OF WHICH APPEAR VISIBLY DEFORMED DUE TO THE DAMAGE. THE AFFECTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591531 ↗
• MalfunctionJul 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, FIVE (5) BOXES OF 5F JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETERS AND TWO (2) BOXES OF 5F MULTIPURPOSE A MPA 2 SH (2 SIDE HOLES) INFINITI CATHETERS WERE FOUND TO BE DAMAGED. NO PATIENT INJURIES WERE REPORTED. THE DAMAGE OCCURRED DURING TRANSPORT AND AFFECTED MULTIPLE LEVELS OF PACKAGING AS WELL AS THE PRODUCTS THEMSELVES. SPECIFICALLY, THE SHIPPING BOX AND OUTER PRODUCT BOXES WERE DAMAGED. THE INNER PRODUCT POUCHES WERE ALSO PUNCTURED FROM THE OUTSIDE, AND THE STERILE POUCHES WERE RECEIVED WITH PUNCTURES; HOWEVER, THE SEALS REMAINED INTACT. THE PRODUCTS WERE NOT STORED IN THE LAB AND HAD NOT BEEN BROUGHT INTO THE LAB PRIOR TO THE DISCOVERY OF THE DAMAGE. THE ACTUAL DEVICES WERE ALSO COMPROMISED, EXHIBITING KINKS THAT RENDER THEM UNSUITABLE FOR USE IN PROCEDURES. AN IMAGE WAS PROVIDED SHOWING MULTIPLE OUTER BOXES OF DIAGNOSTIC CATHETERS INSIDE A SHIPPING CONTAINER, SEVERAL OF WHICH APPEAR VISIBLY DEFORMED DUE TO THE DAMAGE. THE AFFECTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591515 ↗
• MalfunctionJul 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, FIVE (5) BOXES OF 5F JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETERS AND TWO (2) BOXES OF 5F MULTIPURPOSE A MPA 2 SH (2 SIDE HOLES) INFINITI CATHETERS WERE FOUND TO BE DAMAGED. NO PATIENT INJURIES WERE REPORTED. THE DAMAGE OCCURRED DURING TRANSPORT AND AFFECTED MULTIPLE LEVELS OF PACKAGING AS WELL AS THE PRODUCTS THEMSELVES. SPECIFICALLY, THE SHIPPING BOX AND OUTER PRODUCT BOXES WERE DAMAGED. THE INNER PRODUCT POUCHES WERE ALSO PUNCTURED FROM THE OUTSIDE, AND THE STERILE POUCHES WERE RECEIVED WITH PUNCTURES; HOWEVER, THE SEALS REMAINED INTACT. THE PRODUCTS WERE NOT STORED IN THE LAB AND HAD NOT BEEN BROUGHT INTO THE LAB PRIOR TO THE DISCOVERY OF THE DAMAGE. THE ACTUAL DEVICES WERE ALSO COMPROMISED, EXHIBITING KINKS THAT RENDER THEM UNSUITABLE FOR USE IN PROCEDURES. AN IMAGE WAS PROVIDED SHOWING MULTIPLE OUTER BOXES OF DIAGNOSTIC CATHETERS INSIDE A SHIPPING CONTAINER, SEVERAL OF WHICH APPEAR VISIBLY DEFORMED DUE TO THE DAMAGE. THE AFFECTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22590715 ↗

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