INFINITIRecalls & reported problems across all models

We found 20 models of INFINITI by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 107 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2018 and Sep 21, 2026 — classified as 13 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported INFINITI problems

INFINITI models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INFINITI 534621T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  25 reports
• INFINITI 534618T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  14 reports
• INFINITI 534520T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  12 reports
• INFINITI 534620T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  12 reports
• INFINITI 534619T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  10 reports
• INFINITI 534652S

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  6 reports
• INFINITI 538421

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  5 reports
• INFINITI 534542T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  3 reports
• INFINITI 534622T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  3 reports
• INFINITI 538420

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  3 reports
• INFINITI 538450S

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  3 reports
• INFINITI 534648T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 reports
• INFINITI 534676T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 reports
• INFINITI 534660T

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• INFINITI 538422

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• INFINITI 538445

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• INFINITI 538448

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• INFINITI 538455S

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• INFINITI 538472

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• INFINITI 555500T1

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report

Recent INFINITI adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845681 ↗
• MalfunctionSep 21, 2026Detachment of Device or Device Component

  As reported, two 6F 100cm Judkins Right (JR) 4 Vista Brite tip guiding catheters had fractures of the body/shaft section. The damage was identified during preparation and there were no reported injuries to the patient. The devices were stored and prepared in accordance with the instructions for use (IFU). There was no damage to the device packaging and no difficulty removing the devices from the packaging. The facility does not use ultraviolet (UV) light or ozone for room sterilization. Additional details were requested but were not provided. The devices will be returned for evaluation.Addendum: Both devices were returned with separations at the distal tip.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845561 ↗
• MalfunctionSep 3, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50577234 ↗
• MalfunctionSep 2, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573680 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220324 ↗
• 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 ↗
• MalfunctionMar 6, 2026Detachment of Device or Device Component

  AS REPORTED, A 6F JUDKINS LEFT (JL) 3.5 INFINITI DIAGNOSTIC CATHETER BROKE INTO TWO PARTS WHEN ADVANCED OVER THE GUIDE WIRE. THE CATHETER WAS REMOVED, AND A NEW DIAGNOSTIC CATHETER FROM A NON-CORDIS MANUFACTURER WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREPARED ON THE STERILE TABLE, THE INTERNAL LUMEN WAS PURGED, AND IT WAS ATTACHED TO A TEFLON-COATED DIAGNOSTIC GUIDE WIRE PRIOR TO ADVANCEMENT. THE PLANNED PROCEDURE WAS DIAGNOSTIC CORONARY ANGIOGRAPHY. NO PROBLEMS OCCURRED DURING PREPARATION. THE DEVICE WAS NOT USED INSIDE THE PATIENT, AS THE CATHETER BROKE BEFORE INSERTION. THE PRODUCT WAS STORED, HANDLED, AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO DIFFICULTY. NO DAMAGE WAS OBSERVED BEFORE OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. HE DEVICE WAS REMOVED FROM THE PACKAGING BY THE CONNECTOR. IT WAS NOT TORQUED OR STEERED BY THE HUB BUT MANIPULATED BY THE BASE OF THE CATHETER. THE CATHETER BROKE WHILE BEING ADVANCED OVER A TEFLON GUIDE WIRE TOWARD THE INTRODUCER. THERE WAS A LITTLE RESISTANCE DURING INSERTION. THE DEVICE COULD NOT BE ADVANCED BECAUSE THE CATHETER BR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539039 ↗
• InjuryFeb 24, 2026Detachment of Device or Device Component

  AS REPORTED, THE RADIOPAQUE MARKER RING AT THE TIP OF A 6F JUDKIN'S RIGHT (JR) 4 100 CM INFINITI DIAGNOSTIC CATHETER DETACHED DURING WITHDRAWAL AFTER COMPLETION OF ANGIOGRAPHY AND REMAINED IN THE INTERNAL ILIAC ARTERY¿UTERINE ARTERY. A CONTRALATERAL APPROACH WAS NOT USED. THE TARGET SITE VESSEL CHARACTERISTICS WERE SEVERE CALCIFICATION, MODERATE TORTUOSITY, 85% STENOSIS, NO ACUTE ANGLE, AND NO BIFURCATION. THE ACCESS SITE VESSEL CHARACTERISTICS WERE MODERATE CALCIFICATION, MODERATE TORTUOSITY, 80% STENOSIS, NO ACUTE ANGLE, AND NO BIFURCATION. THE DEVICE WAS PULLED OUTWARD FROM THE PACKAGING BY THE HUB AND WAS TORQUED OR STEERED BY THE HUB. NO DIFFICULTIES WERE ENCOUNTERED DURING INSERTION, ADVANCEMENT, OR WITHDRAWAL OF THE DEVICE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE AND WAS PREPPED PER THE INSTRUCTIONS FOR USE WITH NO DIFFICULTY DURING PREPARATION. NO DEVICE DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE CATHETER DID NOT BECOME ENTRAPPED DURING THE PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED OR HAD HOSPITALIZATION EXTENDED DUE TO THE EVENT. THE MARKER RING WAS OBSERVED N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427741 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  AS REPORTED, DURING EXTERNAL SHAPING OF A 6F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER, THE DISTAL TIP BROKE OFF. SIX CATHETERS WERE USED BUT ALL BROKE AT THE DISTAL TIP IN THE SAME MANNER. IT WAS PREVIOUSLY STATED THAT THE CATHETER WAS INTEGRALLY MOLDED, BUT IT WAS LATER FOUND THAT THERE IS A JOINT AT THE DISTAL TIP. THE USER SWITCHED TO A NON-CORDIS DIAGNOSTIC CATHETER, COMPLETED SHAPING, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING OR THE DEVICES PRIOR TO ATTEMPTED SHAPING OF THE DISTAL TIPS. THE INTENDED PROCEDURE WAS AN ANGIOGRAPHY, AND THE TARGET VESSEL WAS THE RIGHT CORONARY ARTERY. THE ACCESS SITE VESSELS WERE NEITHER CALCIFIED NOR TORTUOUS, HAD NO ACUTE ANGLES, AND WERE NOT BIFURCATING. THE DISTAL TIPS OF THE CATHETERS WERE SHAPED BY HAND. NONE OF THE INFINITI CATHETERS WERE INSERTED INTO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224595 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  AS REPORTED, DURING EXTERNAL SHAPING OF A 6F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER, THE DISTAL TIP BROKE OFF. SIX CATHETERS WERE USED BUT ALL BROKE AT THE DISTAL TIP IN THE SAME MANNER. IT WAS PREVIOUSLY STATED THAT THE CATHETER WAS INTEGRALLY MOLDED, BUT IT WAS LATER FOUND THAT THERE IS A JOINT AT THE DISTAL TIP. THE USER SWITCHED TO A NON-CORDIS DIAGNOSTIC CATHETER, COMPLETED SHAPING, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING OR THE DEVICES PRIOR TO ATTEMPTED SHAPING OF THE DISTAL TIPS. THE INTENDED PROCEDURE WAS AN ANGIOGRAPHY, AND THE TARGET VESSEL WAS THE RIGHT CORONARY ARTERY. THE ACCESS SITE VESSELS WERE NEITHER CALCIFIED NOR TORTUOUS, HAD NO ACUTE ANGLES, AND WERE NOT BIFURCATING. THE DISTAL TIPS OF THE CATHETERS WERE SHAPED BY HAND. NONE OF THE INFINITI CATHETERS WERE INSERTED INTO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224321 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  AS REPORTED, DURING EXTERNAL SHAPING OF A 6F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER, THE DISTAL TIP BROKE OFF. SIX CATHETERS WERE USED BUT ALL BROKE AT THE DISTAL TIP IN THE SAME MANNER. IT WAS PREVIOUSLY STATED THAT THE CATHETER WAS INTEGRALLY MOLDED, BUT IT WAS LATER FOUND THAT THERE IS A JOINT AT THE DISTAL TIP. THE USER SWITCHED TO A NON-CORDIS DIAGNOSTIC CATHETER, COMPLETED SHAPING, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING OR THE DEVICES PRIOR TO ATTEMPTED SHAPING OF THE DISTAL TIPS. THE INTENDED PROCEDURE WAS AN ANGIOGRAPHY, AND THE TARGET VESSEL WAS THE RIGHT CORONARY ARTERY. THE ACCESS SITE VESSELS WERE NEITHER CALCIFIED NOR TORTUOUS, HAD NO ACUTE ANGLES, AND WERE NOT BIFURCATING. THE DISTAL TIPS OF THE CATHETERS WERE SHAPED BY HAND. NONE OF THE INFINITI CATHETERS WERE INSERTED INTO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224021 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  AS REPORTED, DURING EXTERNAL SHAPING OF A 6F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER, THE DISTAL TIP BROKE OFF. SIX CATHETERS WERE USED BUT ALL BROKE AT THE DISTAL TIP IN THE SAME MANNER. IT WAS PREVIOUSLY STATED THAT THE CATHETER WAS INTEGRALLY MOLDED, BUT IT WAS LATER FOUND THAT THERE IS A JOINT AT THE DISTAL TIP. THE USER SWITCHED TO A NON-CORDIS DIAGNOSTIC CATHETER, COMPLETED SHAPING, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING OR THE DEVICES PRIOR TO ATTEMPTED SHAPING OF THE DISTAL TIPS. THE INTENDED PROCEDURE WAS AN ANGIOGRAPHY, AND THE TARGET VESSEL WAS THE RIGHT CORONARY ARTERY. THE ACCESS SITE VESSELS WERE NEITHER CALCIFIED NOR TORTUOUS, HAD NO ACUTE ANGLES, AND WERE NOT BIFURCATING. THE DISTAL TIPS OF THE CATHETERS WERE SHAPED BY HAND. NONE OF THE INFINITI CATHETERS WERE INSERTED INTO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223976 ↗
• MalfunctionJan 30, 2026Crack; Detachment of Device or Device Component

  AS REPORTED, DURING EXTERNAL SHAPING OF A 6F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER, THE DISTAL TIP BROKE OFF. SIX CATHETERS WERE USED BUT ALL BROKE AT THE DISTAL TIP IN THE SAME MANNER. IT WAS PREVIOUSLY STATED THAT THE CATHETER WAS INTEGRALLY MOLDED, BUT IT WAS LATER FOUND THAT THERE IS A JOINT AT THE DISTAL TIP. THE USER SWITCHED TO A NON-CORDIS DIAGNOSTIC CATHETER, COMPLETED SHAPING, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING OR THE DEVICES PRIOR TO ATTEMPTED SHAPING OF THE DISTAL TIPS. THE INTENDED PROCEDURE WAS AN ANGIOGRAPHY, AND THE TARGET VESSEL WAS THE RIGHT CORONARY ARTERY. THE ACCESS SITE VESSELS WERE NEITHER CALCIFIED NOR TORTUOUS, HAD NO ACUTE ANGLES, AND WERE NOT BIFURCATING. THE DISTAL TIPS OF THE CATHETERS WERE SHAPED BY HAND. NONE OF THE INFINITI CATHETERS WERE INSERTED INTO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION FOR THE SECOND INFINITI DIAGNOSTIC CATHETER REVEALED THAT THE CATHETER IS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223868 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  AS REPORTED, DURING EXTERNAL SHAPING OF A 6F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER, THE DISTAL TIP BROKE OFF. SIX CATHETERS WERE USED BUT ALL BROKE AT THE DISTAL TIP IN THE SAME MANNER. IT WAS PREVIOUSLY STATED THAT THE CATHETER WAS INTEGRALLY MOLDED, BUT IT WAS LATER FOUND THAT THERE IS A JOINT AT THE DISTAL TIP. THE USER SWITCHED TO A NON-CORDIS DIAGNOSTIC CATHETER, COMPLETED SHAPING, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING OR THE DEVICES PRIOR TO ATTEMPTED SHAPING OF THE DISTAL TIPS. THE INTENDED PROCEDURE WAS AN ANGIOGRAPHY, AND THE TARGET VESSEL WAS THE RIGHT CORONARY ARTERY. THE ACCESS SITE VESSELS WERE NEITHER CALCIFIED NOR TORTUOUS, HAD NO ACUTE ANGLES, AND WERE NOT BIFURCATING. THE DISTAL TIPS OF THE CATHETERS WERE SHAPED BY HAND. NONE OF THE INFINITI CATHETERS WERE INSERTED INTO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223827 ↗
• MalfunctionDec 26, 2025Crack; Crack

  AS REPORTED, A 6F JUDKINS RIGHT (JR4) 100 CM INFINITI DIAGNOSTIC CATHETER FRACTURED DURING USE IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED. ANOTHER INFINITI WAS USED TO COMPLETE THE HANDLING. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE, AND NO DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING, AND THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT ANY DIFFICULTIES. THE HOSPITAL REPORTED THIS CASE AS AN ADVERSE EVENT TO THE CHINA NMPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898770 ↗

Other Cordis US Corp. products

• MYNXGRIP2 models · 2,276 reports · 2 recalls
• Cordis ExoSeal Vascular Closure Device3 models · 1,279 reports
• MYNX CONTROL2 models · 534 reports
• POWERFLEX56 models · 306 reports
• SABER51 models · 270 reports
• Cordis S.M.A.R.T. Control Vascular Stent System30 models · 99 reports · 2 recalls
• AVIATOR19 models · 75 reports
• AVANTI11 models · 70 reports