INFINITI 534619TRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705032014175), received between Jul 26, 2019 and May 21, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THERE WAS A FOREIGN BODY PROTRUDING FROM THE HEAD END OF THE 6F 100CM JUDKIN'S RIGHT (JR) 3.5 INFINITI DIAGNOSTIC CATHETER WHEN THE PACKAGE WAS OPENED AND THE PRODUCT WAS CHECKED. THE PROCEDURE WAS COMPLETED BY CHANGING TO A NEW CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THIS DELAYED THE PATIENT'S DIAGNOSIS AND TREATMENT AND DID NOT CAUSE ANY OTHER DAMAGE TO THE PATIENT. NO DAMAGES WERE FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE PATIENT WAS ADMITTED TO THE CATHETERIZATION LABORATORY FOR CORONARY ANGIOGRAM (CAG) EXAMINATION AND WAS PREPARED TO APPLY THE CONTRAST CATHETER TO VIEW THE CORONARY ARTERIES. AFTER DISCOVERING THE ISSUE, THE CATHETER WAS IMMEDIATELY REPLACED WITH A NEW ONE AND APPLIED AFTER CHECKING THAT THERE WAS NO PROBLEM. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). A CONTRALATERAL APPROACH WAS NOT USED. THE SURGEON DID NOT PROVIDE THE VESSEL CHARACTERISTICS AT THE TARGET SITE OR THE ACCESS SITE. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB, NOR WAS IT TORQUED OR "STEERED" BY THE HUB. NO DIFFICULTIES WERE ENCOUNTERED WHILE ATTEMPTING TO INSERT, ADVANCE, OR WITHDRAW THE DEVICE. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067357 ↗
• MalfunctionMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6F 100 CM JUDKINS RIGHT (JR) INFINITI DIAGNOSTIC CATHETER WAS FOUND CUT WHEN THE NURSE TRIED TO REMOVE IT FROM ITS PACKAGING. ONCE PREPARED AND IN THE CARDIOLOGIST'S HANDS, WHILE PREPARING TO PASS IT THROUGH THE GUIDEWIRE, THE CATHETER WAS STRETCHED AND APPROXIMATELY 6 CM WAS CUT FROM THE TIP. THERE WAS NO REPORTED PATIENT INJURY. THE PLANNED PROCEDURE WAS CARDIAC RESYNCHRONIZATION DEVICE IMPLANTATION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING, AND THE DEVICE WAS PREPARED ACCORDING TO THE IFU. THE STERILE BAG WAS NOT RECEIVED OPEN OR DAMAGED. IT IS NOT POSSIBLE THAT THE PRODUCT WAS INTENTIONALLY OPENED BEFORE USE AND, DUE TO UNUSE, WAS PUT BACK IN STORAGE. THE CONDITION WAS CHECKED BEFORE USE, UPON RECEIPT OF THE PRODUCT, AND AFTER RECEIPT AND STORAGE IN THE LABORATORY BEFORE USE. THE DEVICE WAS STORED IN ITS ORIGINAL PACKAGING. ANOTHER INFINITI WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. AN IMAGE OF THE CATHETER WAS PROVIDED, SHOWING A SEPARATION NEAR THE DISTAL END OF THE DEVICE. THE CATHETER IS SECURED TO A MOUNTING CARD USING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044300 ↗
• MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, UPON OPENING THE PACKAGING OF A 6F 100 CM JUDKINS RIGHT 3.5 INFINITI GUIDING CATHETER, THE CUSTOMER CHECKED THE QUALITY OF THE CATHETER BY LIGHTLY PULLING THE TIP END AND THE CATHETER DISTAL END BROKE AT ABOUT 10 CM. THE BREAK POINT PROXIMAL 1 CM LENGTH WAS HARD TO THE TOUCH. THE BREAK POINT PROXIMAL 2 MM LENGTH THAT COULD BE OBSERVED THICKENING OF THE DIAMETER. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER INFINITI CATHETER WAS USED. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A PICTURE WAS RECEIVED FOR ANALYSIS SHOWING AN APPARENT DX CATHETER WHICH IS NOTED TO HAVE A SEPARATION NEAR THE BRITE TIP/DISTAL TIP. NO OUTSTANDING DETAILS COULD BE NOTED ON THE IMAGE. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056638 ↗
• InjuryAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE OF A 6F 100 CM JUDKINS RIGHT 3.5 INFINITI GUIDING CATHETER FOR IMAGING, IT WAS FOUND THAT THE CONTRAST CATHETER HAD POOR TWIST CONTROL AND THE DISTAL PROXIMAL ROTATIONAL TORQUE WAS NOT SYNCHRONIZED. THE DEVICE SEPARATED (IT BROKE INTO 2 (TWO) OR MORE PIECES. THE PROCEDURE WAS NOT CONTINUED, NO OTHER CATHETER WAS USED. THE CATHETER WAS SUBSEQUENTLY WITHDRAWN AND THE DISTAL END OF THE CATHETER WAS FOUND TO BE FRACTURED AND SEPARATED AND REMAINING IN THE VESSEL, AND THE SEPARATED END WAS LATER REMOVED BY INSTRUMENTED GRASPING. TWO (2) PICTURES WERE RECEIVED FOR REVIEW. THE DEVICE WAS COMPLETELY REMOVED (IN ONE PIECE) FROM THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NO UNUSUAL FORCE NECESSARY DURING USE OF THE DEVICE OR RESISTANCE/FRICTION EXPERIENCED DURING ANY PART OF THE PROCEDURE. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OR EXCESSIVE TORQUING REQUIRED. THE TIP WAS VISIBLE ON FLUOROSCOPY THROUGHOUT THE PROCEDURE. THE CATHETER DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE. THE TARGET LESION WAS MARSHALL VEIN. THERE WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907446 ↗
• MalfunctionMay 20, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP END OF THE 6F JUDKINS RIGHT 3.5 (JR 3.5) INFINITI DIAGNOSTIC CATHETER WAS MISSING WHEN THE PHYSICIAN OPENED THE PACKAGE. THE DEVICE WAS NOT USED IN THE PATIENT. THE PROBLEM WAS FOUND DURING INSPECTION. ANOTHER UNKNOWN CATHETER WAS USED AS REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE AN ANGIOGRAPHY. THE DEVICE WAS STORED, HANDLED, AND INSPECTED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A PICTURE OF THE DEVICE WAS PROVIDED FOR REVIEW CONFIRMING THE DISTAL TIP STILL WAS PRESENT ON THE DISTAL END OF THE UNIT. THE DEVICE WAS RETURNED FOR EVALUATION AND A TORN CONDITION WAS OBSERVED ON THE DISTAL TIP PORTION WHICH PRESENTED EVIDENCE OF ELONGATIONS AND SECONDARY SCRATCH MARKS. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. PLEASE UPGRADE THIS CASE TO AE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352941 ↗
• MalfunctionMay 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A 6F 100CM JUDKINS RIGHT (JR) 3.5 INFINITY DIAGNOSTIC CATHETER WAS CONTAMINATED DUE TO THE OBSERVATION OF A HAIR INSIDE OF THE ¿BAG¿. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE HAS NOW BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17013166 ↗
• MalfunctionMay 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, TWO 6F INFINITI 3.5 X 100CM JR ANGIOGRAPHY DIAGNOSTIC CATHETERS OF THE SAME CATALOG AND LOT NUMBERS WERE INVOLVED IN THE SAME PROCEDURE/SAME PATIENT. THESE TWO DEVICES WERE BOTH FOUND CRACK UPON REMOVAL, WHICH WAS SUSPECTED TO BE RELATED TO PREOPERATIVE PLASTICITY. THE SURGEON RESHAPED THE PRODUCT BY HAND ACCORDING TO THE ANATOMICAL FEATURES OF THE PATIENT AND EXPERIENCE. THE RESHAPING OF THE CATHETER WAS PERFORMED IN THE AREA OF CRACKING/SEPARATING. ONE OF THEM WAS PULLED INTO TWO PIECES OUTSIDE THE PATIENT BY THE SURGEON. ANOTHER CORDIS DEVICE WAS USED TO GET THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. ONLY ONE PICTURE OF THE DEVICE WAS RETAINED. THE INTENDED PROCEDURE WAS AN ANGIOGRAPHY. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE NOR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING OR PREPPING THE DEVICE. THE ACCESS SITE WAS RADIAL. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY. LESION CALCIFICATION, VESSEL TORTUOSITY AND PERCENTAGE STENOSIS ARE UNKNOWN. IT IS NOT KNOWN IF THE DEVICES WERE BEING USED FOR A CHRONIC TOTAL OCCLUSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899248 ↗
• MalfunctionAug 1, 2022Crack; Crack

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F INFINITI JUDKINS RIGHT 3.5 100CM GUIDING CATHETER DURING RIGHT CORONARY ANGIOGRAPHY. IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S VESSEL. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140738 ↗
• MalfunctionJun 21, 2022Material Frayed; Material Frayed

  AS REPORTED, DURING A CORONARY ANGIOGRAPHY, THE NURSE DELIVERED A 6F INFINITI ANGIOGRAPHY CATHETER (CATH F6INF JR 3.5 100CM) TO THE DOCTOR, AND IT WAS FOUND THAT THERE WAS A ¿BURR¿ ON THE TIP OF THE CATHETER. THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. PLEASE UPGRADE THIS CASE TO AE. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758370 ↗
• MalfunctionJul 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE SHAFT OF 6F 3.5 100CM INFINITY DIAGNOSTIC GUIDING CATHETER WAS SEPARATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831225 ↗

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