INFINITI 534618TRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705032014168), received between May 21, 2020 and Mar 6, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 23507516 ↗
• InjuryOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL TIP OF A 6F 100 CM JUDKINS LEFT (JL) 3.5 INFINITI DIAGNOSTIC CATHETER BROKE OFF WHILE THE PHYSICIAN WAS ADVANCING THE SHEATH AND J-WIRE TO THE PATIENT¿S ARTERIOTOMY. MANUAL INTERVENTION DETAILS WERE NOT PROVIDED. THE DISTAL PORTION OF THE CATHETER BECAME ENTRAPPED AND LODGED IN THE AORTIC ARCH. THE PHYSICIAN INITIALLY SNARED THE CATHETER FROM THE RADIAL ARTERY TO PREVENT FURTHER MIGRATION, THEN OBTAINED FEMORAL ACCESS, SNARED THE CATHETER, RELEASED THE RADIAL SNARE, AND REMOVED THE ENTIRE DEVICE THROUGH THE FEMORAL SITE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A LEFT HEART CATHETERIZATION. AFTER AN UNSUCCESSFUL ATTEMPT TO REMOVE A DISLODGED CATHETER TIP THROUGH THE ORIGINAL RADIAL ARTERY ACCESS USING SNARING, THE PHYSICIAN OBTAINED GROIN ACCESS AND SUCCESSFULLY REMOVED THE CATHETER BY SNARING AND PULLING IT OUT THROUGH THE FEMORAL ARTERY. THE CASE WAS DIAGNOSTIC FOR CORONARIES, AND NO SPECIFIC VESSEL CHARACTERISTICS WERE MENTIONED. IT IS ASSUMED THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB, BUT THIS COULD NOT BE VERIFIED. WHETHER THE DEVICE WAS TORQUED OR STEERED BY THE HUB IS ALSO UNVERIFIED. NO DIFFICULTIES WERE NOTED DURING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414430 ↗
• 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 23080035 ↗
• 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 23079523 ↗
• 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 23077664 ↗
• 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 23077370 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6F 100 CM JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETER WAS FOUND TO BE SEPARATED FROM THE TIP, RESULTING IN THE DEVICE BEING BROKEN INTO TWO SEGMENTS DURING AN ANGIOGRAPHY PROCEDURE. A NEW CATHETER OF THE SAME CURVE WAS USED TO COMPLETE THE ANGIOGRAPHY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE HAD BEEN STORED, HANDLED, AND PREPARED IN FULL ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). NO DEVICE DAMAGE WAS OBSERVED PRIOR TO OPENING THE PACKAGING, AND THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING OR DURING PREPARATION. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777916 ↗
• 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 21731110 ↗
• InjuryMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN THE PHYSICIAN REMOVED THE 6F JUDKIN'S LEFT (JL) 3.5 100 CM TL INFINITI DIAGNOSTIC CATHETER FROM THE PATIENT, IT WAS SEPARATED IN TWO PIECES, WITH ONE PORTION LEFT IN THE PATIENT'S ARM. THE PHYSICIAN HAD TO USE A SNARE TO REMOVE THE PIECE THAT WAS BROKEN OFF CAUSING A DELAY IN PROCEDURE. THERE WERE NO ADDITIONAL REPORTS OF PATIENT INJURY. SIX DEVICES OF THE SAME LOT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526268 ↗
• MalfunctionAug 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6F INFINITI JK3.5 100CM GUIDING CATHETER WAS FOUND DAMAGED WHEN THE PACKAGE WAS OPENED. THE PLASTIC PART OF HUB OF THE CATHETER WAS BROKEN AND MISSING. IT WAS NOT THE CATHETER BODY. THERE WAS NO REPORTED PATIENT INJURY. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE INTENDED PROCEDURE WAS DIAGNOSTIC. THE TARGET SITE WAS THE CORONARY ARTERY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE USER IS TRAINED TO THE DEVICE. THE VESSEL AT THE TARGET SITE HAD MILD CALCIFICATION, MILD TORTUOSITY, NO ACUTE OR BIFURCATING ANGLE. THE VESSEL HAD A STENOSIS OF 90%. THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583744 ↗
• MalfunctionOct 6, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A FOREIGN MATERIAL (HAIR) WAS FOUND IN THE INNER PACKAGE OF THE PRODUCT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE OUTER BOX WAS NOT DAMAGED. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE DAMAGE WAS NOTED TO HAVE HAPPENED DURING THE TIME OF OVER-LABELING ACTIVITY IN CUSTOM BONDED WAREHOUSE. THE DEVICE WAS NOT STORED IN THE LAB, IT WAS MAINTAINED IN A WAREHOUSE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15553252 ↗
• InjuryJan 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF THE 6F 100CM JUDKINS LEFT (JL3.5) INFINITI DIAGNOSTIC CATHETER SPLIT INTO 2 SEPARATE PIECES IN THE SUBCLAVIAN ARTERY. IT DID TAKE EXTRA TIME TO REMOVE THE SEPARATED PIECE FROM THE BODY. THE DEVICE WAS REMOVED FROM THE PATIENT WITH A GUIDE CATHETER, 3.0MM BALLOON AND AN .014 WIRE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. ACCESS WAS IN RADIAL ARTERY FOR A LEFT HEART CATHETERIZATION (LHC). THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS NOT RE-STERILIZED. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PATIENT IS CURRENTLY RECOVERED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106430 ↗
• MalfunctionMay 21, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THE CATHETER OF A 6F 3.5 100CM INFINITI JUDKINS LEFT (JL) DIAGNOSTIC CATHETER WAS FOUND DAMAGED WHEN FLUSHING (A PUNCTURE/HOLE ANOMALY IS VISIBLE ON THE BODY/SHAFT OF THE CATHETER). THE PROCEDURE WAS COMPLETED USING ANOTHER INFINITI DIAGNOSTIC CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO VISIBLE DAMAGE TO THE INFINITI DIAGNOSTIC CATHETER NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGING. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS NOT RE-STERILIZED. EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. OTHER ADDITIONAL PATIENT/PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN/NOT AVAILABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION. PHOTOGRAPHS WERE PROVIDED AND AVAILABLE FOR REVIEW. AS PER IMAGE REVIEW: TWO IMAGES WERE RECEIVED FOR REVIEW. IMAGE 1 IS A PICTURE OF A PERSON HOLDING A CATHETER, LIKELY CORDIS. A PUNCTURE/HOLE ANOMALY IS VISIBLE ON THE BODY/SHAFT OF THE CATHETER. IMAGE 2

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10078390 ↗

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