INFINITI 534621TRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705032014199), received between Jan 4, 2021 and Sep 21, 2026 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 25 most recent of 25 reports, 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 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220324 ↗
• 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 ↗
• MalfunctionNov 9, 2025Degraded; Degraded

  AS REPORTED, THE PLASTIC AROUND THE CATHETER HUB OF A 6F JUDKIN¿S RIGHT (JR) 4 100CM THRULUMEN (TL) INFINITI DIAGNOSTIC CATHETER DISINTEGRATED WITHIN THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. THIS ISSUE HAS REPORTEDLY OCCURRED THREE TIMES, INVOLVING THREE SEPARATE CATHETERS. THE STAFF OBSERVED THE CONDITION WHILE STOCKING SHELVES; THE AFFECTED CATHETERS WERE NOT USED ON PATIENTS. THE REPORTER NOTED THAT THE ONLY DIFFERENCE IDENTIFIED IN THE LABORATORY WAS THE USE OF AN ULTRAVIOLET (UV) LIGHT SYSTEM USED TO STERILIZE THE ROOM AFTER CASES. THE DEVICES WERE STORED HANGING IN A CABINET WITH GLASS DOORS THAT INCLUDE BUILT-IN ULTRAVIOLET (UV) STERILIZING LIGHTS. OTHER CORDIS CATHETERS STORED IN THE SAME ENVIRONMENT REPORTEDLY EXHIBITED SIMILAR ISSUES, WHILE OTHER NON-CORDIS CATHETERS DID NOT. THE DEVICES REMAINED IN THEIR WHITE OUTER BOXES UNTIL USE AND WERE NOT REPROCESSED OR RESTERILIZED. THE LABORATORY ROUTINELY USES UV STERILIZATION AND OZONE DISINFECTION DAILY, INCLUDING IN PROCEDURE ROOMS. THE DEVICE PACKAGING REPORTEDLY SHOWED HUB FLAKING PRIOR TO OPENING. DETAILS REGARDING THE SUPPLIER OF THE UV LIGHTING ARE NOT CURRENTLY AVAILABLE. THE THREE DEVICES WILL BE RETURNED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507455 ↗
• MalfunctionAug 29, 2025Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, AN INFINITI JUDKINS RIGHT (JR) 4 100 CM DIAGNOSTIC CATHETER HAD A VERTICAL RIGID HOLE STAMP A FEW INCHES FROM THE DISTAL CATHETER TIP. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND INSPECTED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT CATHETER OF THE SAME CALIBER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929431 ↗
• MalfunctionJun 20, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF A 6F 100 CM JUDKINS RIGHT (JR4) INFINITI DIAGNOSTIC CATHETER WAS NOT SMOOTH. DURING PREP, THE CATHETER TIP WAS FOUND TO HAVE BURRS OR A ROUGH SURFACE, AS SHOWN IN THE ATTACHED IMAGE. ANOTHER INFINITI CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DAMAGE WAS DESCRIBED AS A BURR AT THE DISTAL TIP. THE INTENDED PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE ISSUE WAS IDENTIFIED DURING DEVICE PREPARATION, AND THE PRODUCT WAS NOT USED IN THE PATIENT; THEREFORE, THE HOSPITAL DECLINED TO PROVIDE PATIENT INFORMATION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO DAMAGE OBSERVED PRIOR TO OPENING THE PACKAGING AND NO DIFFICULTY ENCOUNTERED DURING REMOVAL OR PREPARATION. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298325 ↗
• MalfunctionMar 31, 2025Degraded; Degraded

  AS REPORTED, MULTIPLE NEW/UNUSED INFINITI GUIDE CATHETERS HAD FLAKES INSIDE THE PACKAGE. AS IF THE PLASTIC OR COATING DISINTEGRATED. THE FLAKING APPEARS TO BE RIGHT BELOW THE HUB OF THE DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICES ARE STORED WITHIN THE CATH LAB RACK. THE DEVICE IS EXPOSED TO NORMAL LIGHT AND UV SANITIZING LIGHT AFTER A CASE WHEN STORED. THE DEVICES ARE NOT STORED IN THE WHITE OUTER BOX UNTIL THEY ARE USED. THEY ARE STORED IN CABINETS WITH TRANSPARENT GLASS DOORS. THE SHIPMENT OF DEVICES IS STORED DIRECTLY IN THE CATH LAB AND IS NOT EXPOSED TO A NON-CLIMATE-CONTROLLED ENVIRONMENT BEFORE BEING STORED IN THE LAB. THE DEVICE IS NOT REPROCESSED OR RE-STERILIZED. THE DEVICE IS EXPOSED TO UV LIGHTING AS PART OF THE STERILIZATION PROCESS. THE LAB USES UV OR OTHER STERILIZATION PROCESSES IN GENERAL. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731996 ↗
• MalfunctionMar 31, 2025Degraded; Degraded

  AS REPORTED, MULTIPLE NEW/UNUSED INFINITI GUIDE CATHETERS HAD FLAKES INSIDE THE PACKAGE. AS IF THE PLASTIC OR COATING DISINTEGRATED. THE FLAKING APPEARS TO BE RIGHT BELOW THE HUB OF THE DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICES ARE STORED WITHIN THE CATH LAB RACK. THE DEVICE IS EXPOSED TO NORMAL LIGHT AND UV SANITIZING LIGHT AFTER A CASE WHEN STORED. THE DEVICES ARE NOT STORED IN THE WHITE OUTER BOX UNTIL THEY ARE USED. THEY ARE STORED IN CABINETS WITH TRANSPARENT GLASS DOORS. THE SHIPMENT OF DEVICES IS STORED DIRECTLY IN THE CATH LAB AND IS NOT EXPOSED TO A NON-CLIMATE-CONTROLLED ENVIRONMENT BEFORE BEING STORED IN THE LAB. THE DEVICE IS NOT REPROCESSED OR RE-STERILIZED. THE DEVICE IS EXPOSED TO UV LIGHTING AS PART OF THE STERILIZATION PROCESS. THE LAB USES UV OR OTHER STERILIZATION PROCESSES IN GENERAL. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731164 ↗
• MalfunctionMar 31, 2025Degraded; Degraded

  AS REPORTED, MULTIPLE NEW/UNUSED INFINITI GUIDE CATHETERS HAD FLAKES INSIDE THE PACKAGE. AS IF THE PLASTIC OR COATING DISINTEGRATED. THE FLAKING APPEARS TO BE RIGHT BELOW THE HUB OF THE DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICES ARE STORED WITHIN THE CATH LAB RACK. THE DEVICE IS EXPOSED TO NORMAL LIGHT AND UV SANITIZING LIGHT AFTER A CASE WHEN STORED. THE DEVICES ARE NOT STORED IN THE WHITE OUTER BOX UNTIL THEY ARE USED. THEY ARE STORED IN CABINETS WITH TRANSPARENT GLASS DOORS. THE SHIPMENT OF DEVICES IS STORED DIRECTLY IN THE CATH LAB AND IS NOT EXPOSED TO A NON-CLIMATE-CONTROLLED ENVIRONMENT BEFORE BEING STORED IN THE LAB. THE DEVICE IS NOT REPROCESSED OR RE-STERILIZED. THE DEVICE IS EXPOSED TO UV LIGHTING AS PART OF THE STERILIZATION PROCESS. THE LAB USES UV OR OTHER STERILIZATION PROCESSES IN GENERAL. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731074 ↗
• MalfunctionMar 25, 2025Crack; Crack

  AS REPORTED, BLOOD CAME OUT OF THE CRACK FOUND ON THE LUMEN OF A 6F JR4 100CM INFINITI DIAGNOSTIC CATHETER. THE LUMEN HAD BEEN PLACED INTO THE PATIENT WHEN THIS WAS OBSERVED. THE CATHETER WAS REMOVED, AND ANOTHER LUMEN WAS USED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO DAMAGES FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). NO DIFFICULTIES WERE ENCOUNTERED WHILE ATTEMPTING TO INSERT, ADVANCE, OR WITHDRAW THE DEVICE. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686819 ↗
• InjuryFeb 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 6F 100CM JUDKIN'S LEFT (JL) 4 INFINITI DIAGNOSTIC CATHETER WAS NOT FOUND AT THE END OF THE CATHETER. DURING A PROCEDURE ON A PATIENT WITH STENOSIS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, A NON-CORDIS WIRE RADIAL SHEATH WAS INSERTED, FOLLOWED BY THE 0.035-INCH NON-CORDIS GUIDEWIRE STARTER THROUGH AN UNKNOWN JR4 DIAGNOSTIC CATHETER TO DEMONSTRATE THE RIGHT ARTERY. WHEN THE GUIDEWIRE REACHED THE OSTIUM OF THE RIGHT ARTERY, THE PHYSICIAN REMOVED THE WIRE AND NOTICED THAT THE TIP WAS NOT EXACTLY AT THE END OF THE CATHETER. THE PHYSICIAN THOUGHT THE CATHETER WAS SITTING ON THE CASPASE. HOWEVER, WHEN THE CATHETER WAS PULLED UP, THE TIP FLEW OFF AND DISAPPEARED FROM THE PICTURE. THEY IMMEDIATELY CHECKED THE BRAIN AREA TO ENSURE IT HAD NOT TRAVELED THERE. AFTERWARD, THEY DEMONSTRATED THE LEFT SIDE AND SAW THE TIP IN THE CIRCUMFLEX ARTERY. USING A LEFT DIAGNOSTIC CATHETER, THEY CONFIRMED THE TIP WAS SEATED COAXIALLY TO THE ARTERY AND DECIDED TO STOP. THE FOLLOWING MORNING, THE PATIENT COMPLAINED OF CHEST PAINS AND WAS DISCOVERED TO HAVE HAD A MYOCARDIAL INFARCTION (MI). THE CATHETER WAS RE-ENTERED THROUGH THE FEMORAL ARTERY, AN UNKNOWN WIRE WAS PASSED THROUGH

  Patient problems: Myocardial Infarction

  MAUDE report 21333850 ↗
• InjuryJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 6F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER BROKE OFF. AS A RESULT, 70MG/KG OF HEPARIN WAS GIVEN, AN UNKNOWN RADIAL SHEATH WAS UPSIZED, AND THE PIECE WAS RETRIEVED. THERE WAS NO LONG-TERM IMPACT ON THE PATIENT; HOWEVER, PAIN WAS REPORTED AS AN IMPACT OF THE MALFUNCTION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125894 ↗
• MalfunctionJan 5, 2024Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, PER ANVISA NOTIFICATION (B)(4). THE 6F 100 CM VISTA BRITE TIP EXTRA BACK-UP 4 (XB4) GUIDING CATHETER SHOWED HOLES IN ITS MIDDLE THIRD. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, IT COULD NOT BE OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453857 ↗
• MalfunctionApr 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, DURING A CORONARY ANGIOGRAPHY, THE CONNECTOR OF A 6F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER ¿DID NOT MATCH THE TRIPLE TEE PLATE¿ WHICH RESULTED IN AN INABILITY TO ENSURE THE SEALING OF FLUID DURING THE ANGIOGRAPHY. AS A RESULT, AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702881 ↗
• InjuryMar 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A PIECE OF THE TIP OF A 6F JUDKINS RIGHT 4 100CM INFINITI DIAGNOSTIC CATHETER BROKE OFF IN THE PATIENT'S RADIAL ARTERY DURING A CARDIAC CATH WHILE VISUALIZING THE CORONARY ARTERIES. THIS RESULTED IN THE PATIENT NEEDING A FOLLOW UP SURGERY TO REMOVE THE TIP AND WAS REMOVED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE USER WAS TRAINED TO THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554408 ↗
• MalfunctionDec 6, 2022Crack; Crack

  AS REPORTED, THE FRONT END OF A 6F TL JUDKIN'S RIGHT 4 100CM INFINITI DIAGNOSTIC CATHETER WAS FOUND CRACKED WHEN THE SURGEON USED THE CONTRAST AGENT THRUSTER. THE CATHETER COULD NO LONGER BE USED DURING THE PROCEDURE AND SO IT WAS REPLACED IMMEDIATELY WITH A NEW UNKNOWN ANGIOGRAPHY CATHETER. THERE WERE NO ISSUES WITH THE NEW CATHETER, AND IT WAS USED NORMALLY. THERE WERE NO REPORTS OF PATIENT INJURY, AS THE DEVICE WAS NOT USED IN THE PATIENT. HOWEVER, THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. THE DEVICE WAS INTENDED TO BE USED IN A CORONARY ARTERY ANGIOGRAPHY. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THERE WAS NO DAMAGE NOTED ON THE PACKAGE PRIOR TO USE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923631 ↗
• MalfunctionJan 4, 2021Material Puncture/Hole; Material Puncture/Hole

  WHEN OPENING THE POUCH AND PREPARING THE 6F 100CM JUDKINS RIGHT (JR4) INFINITI DIAGNOSTIC CATHETER, THE STERILE NURSE IDENTIFIED A SMALL HOLE APPROX. 15CM DISTAL OF THE TIP. THEREFORE, A NEW CATHETER (UNKNOWN) WAS OPENED AND USED FOR THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. A NEW DIAGNOSTIC CATHETER, SAME SHAPE AND SIZE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS A STANDARD DIAGNOSTIC FOR THE LEFT CORONARY ARTERY (LCA). THE DEVICE WAS HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. THERE WERE NO EXCESSIVE FORCE USED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108439 ↗

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