INFINITI 534520TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705032013680), received between Nov 13, 2023 and Sep 17, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Degraded” (10 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.

• MalfunctionSep 17, 2025Degraded; Degraded

  THE DEVICE WAS NOT RETURNED FOR EVALUATION AS ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078335 ↗
• 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 23077877 ↗
• 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 23077859 ↗
• MalfunctionSep 17, 2025Degraded; Degraded

  THE DEVICE WAS NOT RETURNED FOR EVALUATION AS ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077777 ↗
• 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 20913176 ↗
• 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 20912945 ↗
• 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 20912944 ↗
• 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 20912926 ↗
• 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 20912600 ↗
• 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 20912466 ↗
• 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 CLINIQUE DES GRANGETTES 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 19686025 ↗
• MalfunctionNov 13, 2023Crack; Crack

  AS REPORTED, THE TIP END OF THE 5F JUDKINS LEFT 4 (JL4) INFINITI DIAGNOSTIC CATHETER FRACTURED INSIDE THE BODY DURING ANGIOGRAPHY. THE DEVICE CRACKED; THE TIP OF THE CATHETER CRACKED AS IF IT HAD BEEN CUT OUT. NO SEGMENT SEPARATED IN THE BODY; THE ANGIOGRAPHY CATHETER WAS WITHDRAWN. A NON-CORDIS CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. VESSEL AND LESION CHARACTERISTICS DETAILS WERE NOT PROVIDED BUT THEY WERE DESCRIBED AS 'NORMAL'. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULT EXPERIENCE IN PREPPING THE DEVICE AND NO RESISTANT FRICTION EXPERIENCED DURING ANY PART OF THE PROCEDURE. THE GUIDEWIRE WAS FOUND TO COME OUT FROM THE DAMAGED PART OF THE ANGIOGRAPHY CATHETER WHEN IT WAS ADVANCED IN THE ANGIOGRAPHY CATHETER. THERE WAS NO UNUSUAL FORCE NECESSARY DURING THE USE OF THE DEVICE OR EXCESSIVE TORQUING REQUIRED. THE TIP WAS VISIBLE ON FLUOROSCOPY THROUGHOUT THE PROCEDURE. THE DEVICE WAS NOT RESTERILIZED. THE PRODUCT IS NOW AVAILABLE AND WILL BE RETURNED. FIVE (5) DEVICE PICTURES WERE RECEIVED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118433 ↗

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