INFINITI 534518TRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705032013666), received between Feb 16, 2024 and Sep 17, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Degraded” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 23079907 ↗
• 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 23079213 ↗
• 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 23079002 ↗
• 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 23077262 ↗
• 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 23077149 ↗
• 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 23077066 ↗
• 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 23077011 ↗
• 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 23076961 ↗
• MalfunctionJul 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, FIVE (5) BOXES OF 5F JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETERS AND TWO (2) BOXES OF 5F MULTIPURPOSE A MPA 2 SH (2 SIDE HOLES) INFINITI CATHETERS WERE FOUND TO BE DAMAGED. NO PATIENT INJURIES WERE REPORTED. THE DAMAGE OCCURRED DURING TRANSPORT AND AFFECTED MULTIPLE LEVELS OF PACKAGING AS WELL AS THE PRODUCTS THEMSELVES. SPECIFICALLY, THE SHIPPING BOX AND OUTER PRODUCT BOXES WERE DAMAGED. THE INNER PRODUCT POUCHES WERE ALSO PUNCTURED FROM THE OUTSIDE, AND THE STERILE POUCHES WERE RECEIVED WITH PUNCTURES; HOWEVER, THE SEALS REMAINED INTACT. THE PRODUCTS WERE NOT STORED IN THE LAB AND HAD NOT BEEN BROUGHT INTO THE LAB PRIOR TO THE DISCOVERY OF THE DAMAGE. THE ACTUAL DEVICES WERE ALSO COMPROMISED, EXHIBITING KINKS THAT RENDER THEM UNSUITABLE FOR USE IN PROCEDURES. AN IMAGE WAS PROVIDED SHOWING MULTIPLE OUTER BOXES OF DIAGNOSTIC CATHETERS INSIDE A SHIPPING CONTAINER, SEVERAL OF WHICH APPEAR VISIBLY DEFORMED DUE TO THE DAMAGE. THE AFFECTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589703 ↗
• MalfunctionJul 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, FIVE (5) BOXES OF 5F JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETERS AND TWO (2) BOXES OF 5F MULTIPURPOSE A MPA 2 SH (2 SIDE HOLES) INFINITI CATHETERS WERE FOUND TO BE DAMAGED. NO PATIENT INJURIES WERE REPORTED. THE DAMAGE OCCURRED DURING TRANSPORT AND AFFECTED MULTIPLE LEVELS OF PACKAGING AS WELL AS THE PRODUCTS THEMSELVES. SPECIFICALLY, THE SHIPPING BOX AND OUTER PRODUCT BOXES WERE DAMAGED. THE INNER PRODUCT POUCHES WERE ALSO PUNCTURED FROM THE OUTSIDE, AND THE STERILE POUCHES WERE RECEIVED WITH PUNCTURES; HOWEVER, THE SEALS REMAINED INTACT. THE PRODUCTS WERE NOT STORED IN THE LAB AND HAD NOT BEEN BROUGHT INTO THE LAB PRIOR TO THE DISCOVERY OF THE DAMAGE. THE ACTUAL DEVICES WERE ALSO COMPROMISED, EXHIBITING KINKS THAT RENDER THEM UNSUITABLE FOR USE IN PROCEDURES. AN IMAGE WAS PROVIDED SHOWING MULTIPLE OUTER BOXES OF DIAGNOSTIC CATHETERS INSIDE A SHIPPING CONTAINER, SEVERAL OF WHICH APPEAR VISIBLY DEFORMED DUE TO THE DAMAGE. THE AFFECTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589544 ↗
• MalfunctionJul 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, FIVE (5) BOXES OF 5F JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETERS AND TWO (2) BOXES OF 5F MULTIPURPOSE A MPA 2 SH (2 SIDE HOLES) INFINITI CATHETERS WERE FOUND TO BE DAMAGED. NO PATIENT INJURIES WERE REPORTED. THE DAMAGE OCCURRED DURING TRANSPORT AND AFFECTED MULTIPLE LEVELS OF PACKAGING AS WELL AS THE PRODUCTS THEMSELVES. SPECIFICALLY, THE SHIPPING BOX AND OUTER PRODUCT BOXES WERE DAMAGED. THE INNER PRODUCT POUCHES WERE ALSO PUNCTURED FROM THE OUTSIDE, AND THE STERILE POUCHES WERE RECEIVED WITH PUNCTURES; HOWEVER, THE SEALS REMAINED INTACT. THE PRODUCTS WERE NOT STORED IN THE LAB AND HAD NOT BEEN BROUGHT INTO THE LAB PRIOR TO THE DISCOVERY OF THE DAMAGE. THE ACTUAL DEVICES WERE ALSO COMPROMISED, EXHIBITING KINKS THAT RENDER THEM UNSUITABLE FOR USE IN PROCEDURES. AN IMAGE WAS PROVIDED SHOWING MULTIPLE OUTER BOXES OF DIAGNOSTIC CATHETERS INSIDE A SHIPPING CONTAINER, SEVERAL OF WHICH APPEAR VISIBLY DEFORMED DUE TO THE DAMAGE. THE AFFECTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589476 ↗
• MalfunctionJul 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, FIVE (5) BOXES OF 5F JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETERS AND TWO (2) BOXES OF 5F MULTIPURPOSE A MPA 2 SH (2 SIDE HOLES) INFINITI CATHETERS WERE FOUND TO BE DAMAGED. NO PATIENT INJURIES WERE REPORTED. THE DAMAGE OCCURRED DURING TRANSPORT AND AFFECTED MULTIPLE LEVELS OF PACKAGING AS WELL AS THE PRODUCTS THEMSELVES. SPECIFICALLY, THE SHIPPING BOX AND OUTER PRODUCT BOXES WERE DAMAGED. THE INNER PRODUCT POUCHES WERE ALSO PUNCTURED FROM THE OUTSIDE, AND THE STERILE POUCHES WERE RECEIVED WITH PUNCTURES; HOWEVER, THE SEALS REMAINED INTACT. THE PRODUCTS WERE NOT STORED IN THE LAB AND HAD NOT BEEN BROUGHT INTO THE LAB PRIOR TO THE DISCOVERY OF THE DAMAGE. THE ACTUAL DEVICES WERE ALSO COMPROMISED, EXHIBITING KINKS THAT RENDER THEM UNSUITABLE FOR USE IN PROCEDURES. AN IMAGE WAS PROVIDED SHOWING MULTIPLE OUTER BOXES OF DIAGNOSTIC CATHETERS INSIDE A SHIPPING CONTAINER, SEVERAL OF WHICH APPEAR VISIBLY DEFORMED DUE TO THE DAMAGE. THE AFFECTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589328 ↗
• MalfunctionJul 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, FIVE (5) BOXES OF 5F JUDKINS LEFT 3.5 (JL3.5) INFINITI DIAGNOSTIC CATHETERS AND TWO (2) BOXES OF 5F MULTIPURPOSE A MPA 2 SH (2 SIDE HOLES) INFINITI CATHETERS WERE FOUND TO BE DAMAGED. NO PATIENT INJURIES WERE REPORTED. THE DAMAGE OCCURRED DURING TRANSPORT AND AFFECTED MULTIPLE LEVELS OF PACKAGING AS WELL AS THE PRODUCTS THEMSELVES. SPECIFICALLY, THE SHIPPING BOX AND OUTER PRODUCT BOXES WERE DAMAGED. THE INNER PRODUCT POUCHES WERE ALSO PUNCTURED FROM THE OUTSIDE, AND THE STERILE POUCHES WERE RECEIVED WITH PUNCTURES; HOWEVER, THE SEALS REMAINED INTACT. THE PRODUCTS WERE NOT STORED IN THE LAB AND HAD NOT BEEN BROUGHT INTO THE LAB PRIOR TO THE DISCOVERY OF THE DAMAGE. THE ACTUAL DEVICES WERE ALSO COMPROMISED, EXHIBITING KINKS THAT RENDER THEM UNSUITABLE FOR USE IN PROCEDURES. AN IMAGE WAS PROVIDED SHOWING MULTIPLE OUTER BOXES OF DIAGNOSTIC CATHETERS INSIDE A SHIPPING CONTAINER, SEVERAL OF WHICH APPEAR VISIBLY DEFORMED DUE TO THE DAMAGE. THE AFFECTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589316 ↗
• InjuryMay 23, 2025Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, WHEN INTRODUCING A 5F 100CM JUDKINS LEFT (JL) 3.5 INFINITI DIAGNOSTIC CATHETER INSIDE OF THE PATIENT VIA THE RIGHT RADIAL ARTERY, THE PATIENT REPORTED BEING IN PAIN. A SPASM OCCURRED IN THE RIGHT RADIAL ARTERY WHILE ADVANCING THE CATHETER AND WAS TREATED WITH MEDICATION. THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT, AND A PUNCTURE WAS OBSERVED ON THE DISTAL CURVE OF THE DEVICE. ONE IMAGE WAS PROVIDED, AND IT SHOWS A PUNCTURED CONDITION TO THE DISTAL PORTION OF THE DEVICE, AND IT IS DISTAL TO A FUSION LINE. ONE VIDEO WAS PROVIDED, AND IT SHOWS SALINE FLOWING FROM THE PUNCTURE. A NEW 5F 100CM JUDKINS LEFT (JL) 3.5 INFINITI DIAGNOSTIC CATHETER WAS USED AS A REPLACEMENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE DEVICE PACKAGING PRIOR TO USE, AND THERE WAS NO DIFFICULTY IN REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS SUCCESSFULLY FLUSHED DURING PREPARATION, AND IT WAS REPORTED THAT SALINE WAS OBSERVED COMING FROM THE PUNCTURE AT THE DISTAL TIP DURING PREPARATION. VESSEL CHARACTERISTICS AT THE ACCESS SITE WERE NEITHER CALCIFIED NOR TORTUOUS. THE DEVICE WAS INSERTED OVER A 0.035¿X150 NON-CORDIS GUIDEWIRE

  Patient problems: Vasoconstriction

  MAUDE report 22078417 ↗
• 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 20913078 ↗
• MalfunctionNov 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE CATHETER TIP OF A 5F JUDKIN'S LEFT (JL) 3.5 .047-INCH INFINITI DIAGNOSTIC CATHETER SEPARATED DURING PREP WHILE SHAPING THE CATHETER OUTSIDE OF THE PATIENT DURING A PROCEDURE IN ANTICIPATION OF A CORONARY ANGIOGRAPHY. THE CATHETER WAS IMMEDIATELY REPLACED WITH A NEW ONE. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH PRODUCTS HANGING IN THE HOSPITAL AND MANAGED STRICTLY. NO DAMAGES WERE FOUND ON THE DEVICE PACKAGING PRIOR TO USE/OPENING. NO EXCESS FORCE WAS USED IN THE PREPARATION OF THIS DEVICE, JUST REGULAR FORCE. THE HOSPITAL REPORTED THIS CASE AS A SERIOUS INJURY ADVERSE EVENT TO CHINA NMPA DIRECTLY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780614 ↗
• InjuryJul 8, 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 19686929 ↗
• MalfunctionFeb 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A FOREIGN SUBSTANCE WAS FOUND INSIDE THE PACKAGING OF THE CONTRAST TUBE OF A 5F JUDKINS LEFT (JL) INFINITI DIAGNOSTIC CATHETER. THE ISSUE WAS FOUND AFTER DELIVERING THE GOODS TO THE HOSPITAL, WHEN IT WAS READY TO BE DELIVERED TO THE OPERATING ROOM AFTER UNPACKING THE OUTER PACKAGING IN THE EQUIPMENT SECTION. THE DEVICE DID NOT MEET THE STERILITY STANDARDS. THE PRODUCT WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT IS EXPECTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727156 ↗

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