INFINITI 534620TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705032014182), received between Apr 20, 2021 and Mar 10, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Detachment of Device or Device Component

  AS REPORTED, WHILE PREPARING THE 6F TL JL 4 INFINITI, IT WAS FOUND THAT THE ENTIRE CURVED TIP SECTION WAS SEPARATED AND DETACHED AFTER OPENING AND MANUALLY STRAIGHTENING THE PRODUCT. THE DEVICE DID NOT ENTER THE PATIENT, AS BREAKAGE WAS DETECTED DURING PREPARATION OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT CATHETER. THERE WAS NO REPORTED INJURY AS THIS WAS FOUND DURING PREP. THE DEVICE PACKAGING WAS INTACT. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE INTENDED PROCEDURE WAS ANGIOGRAPHIC EXAMINATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557383 ↗
• MalfunctionApr 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED VIA (B)(6) NOTIFICATION (B)(4), A STRAND OF HAIR WAS FOUND INSIDE THE STERILE PACKAGING OF A 6F 100 CM JUDKINS LEFT (JL4) INFINITI DIAGNOSTIC CATHETER WHICH WAS NOT OPENED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881460 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF TWO INFINITI JUDKINS LEFT (JL) 4 DIAGNOSTIC CATHETERS WERE FOUND "FRACTURED" WHEN OPENING THE PACKAGING. THERE WAS NO REPORTED PATIENT INJURY. AN IMAGE WAS RECEIVED SHOWING 2 CATHETERS WITH THE TIPS SEPARATED. THE DEVICE WAS NOT USED ON PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DAMAGES WERE NOT NOTED BEFORE REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICES WERE FOUND FRACTURED ON THE TIP WHEN REMOVING THEM FROM THE PACKAGE. NO RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE. THE DEVICE WAS NOT RESTERILIZED. THE DEVICES DID NOT KINK IN THE AREA OF SEPARATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830915 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF TWO INFINITI JUDKINS LEFT (JL) 4 DIAGNOSTIC CATHETERS WERE FOUND "FRACTURED" WHEN OPENING THE PACKAGING. THERE WAS NO REPORTED PATIENT INJURY. AN IMAGE WAS RECEIVED SHOWING 2 CATHETERS WITH THE TIPS SEPARATED. THE DEVICE WAS NOT USED ON PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DAMAGES WERE NOT NOTED BEFORE REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICES WERE FOUND FRACTURED ON THE TIP WHEN REMOVING THEM FROM THE PACKAGE. NO RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE. THE DEVICE WAS NOT RESTERILIZED. THE DEVICES DID NOT KINK IN THE AREA OF SEPARATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830865 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF TWO INFINITI JUDKINS LEFT (JL) 4 DIAGNOSTIC CATHETERS WERE FOUND "FRACTURED" WHEN OPENING THE PACKAGING. THERE WAS NO REPORTED PATIENT INJURY. AN IMAGE WAS RECEIVED SHOWING 2 CATHETERS WITH THE TIPS SEPARATED. THE DEVICE WAS NOT USED ON PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DAMAGES WERE NOT NOTED BEFORE REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICES WERE FOUND FRACTURED ON THE TIP WHEN REMOVING THEM FROM THE PACKAGE. NO RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE. THE DEVICE WAS NOT RESTERILIZED. THE DEVICES DID NOT KINK IN THE AREA OF SEPARATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830859 ↗
• MalfunctionAug 12, 2024Material Separation; Material Separation

  AS REPORTED, THE TIP OF A 6F 100CM INFINITI JUDKINS LEFT CORONARY DIAGNOSTIC CATHETER WAS BROKEN WHILE TAKING THE CATHETER OUT OF THE PACKAGE. PRELIMINARY IMAGE REVIEW DEMONSTRATES THAT THE DISTAL TIP IS SEPARATED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS INITIALLY WAS REPORTED/EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966421 ↗
• MalfunctionJul 22, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE 6F .070 VISTA BRITE XB 3.5 100CM AND 6F 100CM INFINITI JL4 WAS FOUND TO HAVE A FOREIGN SUBSTANCE IN THE PRODUCT PACKAGING. THE IMAGES REVIEWED WERE SHOWING A SUBSTANCE THAT LOOKS LIKE A PIECE OF HAIR. THE PROBLEM WAS FOUND AT THE DISTRIBUTOR, THE PRODUCT HAD NOT BEEN SENT TO THE HOSPITAL. THE DEVICE WAS STORED FOR 14 DAYS IN THE RECEIVING AREA. THE SUBSTANCE LOOKED LIKE A PIECE OF HAIR. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE INTEGRITY OF THE STERILE PACKAGE WAS NOT COMPROMISED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800807 ↗
• InjuryJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING THE PROCEDURE, THE TIP OF A 6F 100CM JUDKIN'S LEFT (JL) 4 INFINITI DIAGNOSTIC CATHETER BECAME DISLODGED. THE DEVICE WAS FOUND TO BE DEFECTIVE AFTER INSERTING INTO PATIENT. SECOND GROIN ACCESS TO THE LEFT FEMORAL ARTERY WAS OBTAINED. THE PHYSICIAN SNARED THE LOOSE PIECE OUT OF THE PATIENT'S BODY SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT INJURY. THE PATIENT IS A MIDDLE-AGED FEMALE WITH A PAST MEDICAL HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, DIABETES WHO PRESENTS TO THE CARDIAC CATHETERIZATION LAB WITH CANADIAN CLASS III ANGINA DESPITE OPTIMAL MEDICAL THERAPY. DIAGNOSTIC FINDINGS REVEALED: THERE WAS 30% STENOSIS OF THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), WHICH IS ASSOCIATED WITH MYOCARDIAL BRIDGE; THERE WAS A PATENT STENT IN THE PROXIMAL LAD; THERE WAS A PATENT LEFT MAIN; THERE WAS MILD DIFFUSE DISEASE IN THE LEFT CIRCUMFLEX, THERE WAS 40% STENOSIS OF THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559951 ↗
• MalfunctionMay 31, 2024Crack; Material Frayed; Material Split, Cut or Torn; Crack; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE DISTAL TIP OF THE 6F 100 CM INFINITI JUDKINS LEFT (JL4) DIAGNOSTIC CATHETER WAS FOUND CRACKED WHEN THE PRODUCT WAS OPENED. THE PRODUCT WAS NOT USED IN THE PATIENT. ANOTHER UNKNOWN CATHETER WAS USED TO COMPLETE THE CORONARY ANGIOGRAPHY PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19433872 ↗
• MalfunctionFeb 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, MATERIAL WITH HAIR WAS FOUND INSIDE THE STERILE PACKAGING OF A 6F 100 CM JUDKINS LEFT 4 (JL4) INFINITI DIAGNOSTIC CATHETER PER ANVISA NOTIFICATION (B)(4). THE PACKAGING HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. CUSTOMER IDENTIFICATION WAS NOT PROVIDED IN THE ANVISA WEBSITE, AND THE SUBMITTER DID NOT HAVE MORE INFORMATION ABOUT THIS CASE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, COULD NOT BE OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772922 ↗
• MalfunctionFeb 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 6F 100CM JUDKINS LEFT (JL) 4 INFINITI DIAGNOSTIC CATHETER APPEARED CUT. THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS NOT RETURNED AS EXPECTED. ADDENDUM: RECEIVED DEVICE IMAGES SHOW THE CATHETER IS SEPARATED IN TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721887 ↗
• MalfunctionApr 20, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  AS REPORTED, THE PHYSICIAN NOTICED THAT THERE WAS BLOOD DRIPPING OUT OF A HOLE IN THE 6F 100CM JUDKINS LEFT 4 (JL4) INFINITI CATHETER WHEN HE PUT IT THROUGH THE SHEATH (UNKNOWN). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING INTO THE PATIENT. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693700 ↗

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