INFINITI 534521TRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705032013697), received between Nov 1, 2017 and Jul 22, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Leak/Splash; Leak/Splash

  AS REPORTED, THERE WAS A GAP AT THE HANDLE OF THE 5F JUDKIN'S RIGHT (JR) 4 100 CM INFINITI DIAGNOSTIC CATHETER CAUSING BUBBLES. ANOTHER CATHETER WAS USED, AND THE PROCEDURE WAS COMPLETED SMOOTHLY. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568431 ↗
• MalfunctionDec 12, 2024Degraded; Degraded

  AS REPORTED, SIX (6) UNOPENED 5F 100CM JUDKINS LEFT (JL) 4 INFINITI DIAGNOSTIC CATHETERS, ONE (1) UNOPENED 5F 100CM JUDKINS LEFT (JL) 3.5 INFINITI DIAGNOSTIC CATHETER, AND ONE (1) UNOPENED 5F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER WERE FOUND TO BE COMING APART WITHIN THEIR PACKAGING. THE DEVICES APPEAR TO BE ¿DRY ROTTING¿, AND THE BLUE POLYTETRAFLUOROETHYLENE (PTFE) COATING IS FLAKING OFF INSIDE OF THEIR PACKAGING. THE FLAKING APPEARS TO BE COMING FROM WHERE THE HUB IS ATTACHED TO THE CATHETER COLLAR ON EACH DEVICE. THE ISSUE WAS FOUND DURING A REVIEW OF INVENTORY AND THE DEVICES WERE NOT SELECTED FOR A PROCEDURE OR OPENED FOR USE. THE DEVICES WERE STORED IN A PYXIS MACHINE AND WERE NOT EXPOSED TO ULTRAVIOLET (UV) LIGHT. THERE WERE NO DAMAGES TO THE PACKAGING FOR THESE DEVICES AND THE DEVICES ARE STILL WITHIN THEIR STERILE PACKAGING. IT WAS CONFIRMED THAT THE DEVICES ARE NOT EXPIRED. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913147 ↗
• MalfunctionSep 9, 2024Crack; Difficult to Remove; Crack; Difficult to Remove

  AS REPORTED, WHEN ROTATING THE 5F CORDIS INFINITI JR4 CONTRAST CATHETER TO EVACUATE THE RIGHT CORONARY SINUS, IT WAS FOUND THAT THE JR4 CONTRAST CATHETER WAS FRACTURED AND TWISTED AT THE CLAVICLE, RESULTING IN THE CATHETER NOT BEING ABLE TO PIVOT OUT PROPERLY. AFTER REPEATED ROTATION AND GUIDEWIRE-ASSISTED TREATMENT, THE CATHETER WAS SUCCESSFULLY WITHDRAWN, RESULTING IN SPASM OF THE RIGHT RADIAL ARTERY, BUT THERE WAS NO EXUDATION OR RETENTION OF CONTRAST MEDIUM, AND THE PROCEDURE WAS COMPLETED, AND THE PATIENT RETURNED TO THE WARD SAFELY. THE SURGEON PERFORMED CORONARY ANGIOGRAPHY ACCORDING TO THE OPERATING PROCEDURES. AN ULTRA-SMOOTH GUIDEWIRE WAS CHOSEN TO ASSIST THE UNKNOWN MULTIFUNCTIONAL CONTRAST CATHETER TO REACH THE BASE OF THE AORTA. DURING THE DELIVERY PROCESS, THE SUBCLAVIAN ARTERY WAS SEEN TO BE TWISTED DURING CONTRAST INJECTION. THE LEFT CORONARY ANGIOGRAPHY WAS SUCCESSFULLY PERFORMED USING AN UNKNOWN MULTIFUNCTIONAL CONTRAST CATHETER ASSISTED BY A J-SHAPED GUIDEWIRE. HOWEVER, AFTER REPEATED ATTEMPTS, THE MULTIFUNCTIONAL CATHETER WAS UNABLE TO REACH THE RIGHT CORONARY ORIFICE. THE JR4 CONTRAST CATHETER WAS THEN SELECTED AND STILL COULD NOT REACH THE RIGHT CORONARY ORIFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171043 ↗
• InjuryJul 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT FELL INTO ANAPHYLACTIC SHOCK DURING A CARDIAC PROCEDURE WITH THE USE OF A 0.035IN FIXED-CORE J- CURVE 3MM X 175CM EMERALD DIAGNOSTIC GUIDEWIRE, THREE 5F JUDKIN'S LEFT (JL) 4 100CM INFINITI DIAGNOSTIC CATHETER, AND A 5.2F JUDKIN'S RIGHT (JR) 4 125CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THE PRODUCT WAS INSPECTED BEFORE USE AND APPEARED TO BE NORMAL. NO INFORMATION WAS PROVIDED REGARDING THE ACTIONS PERFORMED ON THE GUIDEWIRE TO PREPARE IT FOR USE, BUT NO SPECIAL PROBLEMS WERE DETECTED DURING THE PREPARATION. THE GUIDEWIRE WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS REMOVED EASILY AND INTACT FROM THE PATIENT. THE CARDIAC PROCEDURE WAS COMPLETED SUCCESSFULLY AT (B)(6) IN GENEVA. THE PATIENT'S CONDITION IS COMPLETELY STABLE, AND THEY HAVE BEEN AT HOME FOR SEVERAL MONTHS. HOWEVER, THEY WILL NEED TO UNDERGO A NEW PROCEDURE IN THE COMING WEEKS. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE USED MONTHS AGO, AND THE DEVICES ARE NO LONGER AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19686850 ↗
• MalfunctionJan 12, 2024Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A HOLE WAS FOUND MIDWAY DOWN A 5F 100 CM INFINITI JUDKINS RIGHT (JR4) DIAGNOSTIC CATHETER WHEN OPENED. THE PACKAGING WAS INTACT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ANGIOGRAPHY WAS REPORTED TO BE THE INTENDED PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501508 ↗
• MalfunctionApr 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F INF JR 4 100CM GUIDING CATHETER TIP CAME APART FROM THE PROBE, DETACHMENT OF THE TWO PARTS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE SEPARATED IN TWO PIECES WHEN IT WAS REMOVED FROM THE PACKAGE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICE DID NOT SEPARATE INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8564784 ↗
• MalfunctionNov 1, 2017Device Packaging Compromised; Device Contamination with Chemical or Other Material; Device Packaging Compromised; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE F5 INFINITI JR 4 100CM CATHETER WAS SEALED AND A STRAND OF HAIR WAS NOTED WHEN THE DEVICE WAS BEING STOCKED IN THE CATH LAB. THERE WAS NO PATIENT INJURY. THERE WERE NO DAMAGES NOTED TO THE PACKAGING. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6995119 ↗

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