INFINITI 534642TRecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10705032014304), received between Jan 25, 2024 and Mar 25, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (67 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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE WAS LOCATED AT THE BODY NEAR THE TIP AND RESULTED IN COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING PRIOR TO USE. THE CATHETER WAS REMOVED TOGETHER WITH THE CARDBOARD HOLDER. PRIOR TO OBSERVING THE FRACTURE, THE PREPARATION STEP PERFORMED WAS SHAPING THE TIP. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690080 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE WAS LOCATED AT THE BODY NEAR THE TIP AND RESULTED IN COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING PRIOR TO USE. THE CATHETER WAS REMOVED TOGETHER WITH THE CARDBOARD HOLDER. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689975 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689916 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689821 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689742 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689714 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689671 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689626 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689509 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689446 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689385 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE DEVICE WAS STORED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE DEVICE PACKAGING PRIOR TO USE; HOWEVER, DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE CATHETER WAS REMOVED TOGETHER WITH THE CARDBOARD HOLDER. THE FRACTURE OCCURRED AT THE CATHETER BODY NEAR THE TIP AND RESULTED IN COMPLETE SEPARATION OF THE DEVICE. ANOTHER MPA (534642T) WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689316 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  AS REPORTED, THE 6F MP A2 INFINITI ANGIOGRAPHY CATHETER BROKE INTO THREE PIECES AS SOON AS IT WAS TAKEN OUT, SO WE REPLACED IT WITH ANOTHER CATHETER AND CONTINUED USING IT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663688 ↗
• MalfunctionMar 12, 2026Detachment of Device or Device Component

  AS REPORTED, TWO 6F MULTIPURPOSE (MP) A2 100CM INFINITI THRULUMEN DIAGNOSTIC CATHETER BROKE DURING SHAPING. THE STRAIN RELIEF PORTION OF THE DEVICE BROKE DURING SHAPING, RESULTING IN A FRACTURE AND SEPARATION INTO MULTIPLE PIECES. THE SURGEON IMMEDIATELY STOPPED USING THE CATHETERS AND REPLACED THEM WITH ANOTHER NON-CORDIS CATHETER TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT OCCURRED DURING A PATENT DUCTUS ARTERIOSUS (PDA) SURGICAL PROCEDURE AFTER AN UNKNOWN GUIDEWIRE HAD BEEN REMOVED. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). SHAPING WAS PERFORMED OUTSIDE OF THE PATIENT, AND THE BREAKAGE ALSO OCCURRED OUTSIDE OF THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS CASE AS A SERIOUS INJURY ADVERSE EVENT TO THE CHINA NMPA.ADDENDUM: BOTH DEVICES WERE RETURNED WITH SEPARATIONS AT THE DISTAL TIP AND THE STRAIN RELIEFS FULLY INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583488 ↗
• MalfunctionMar 12, 2026Detachment of Device or Device Component

  AS REPORTED, TWO 6F MULTIPURPOSE (MP) A2 100CM INFINITI THRULUMEN DIAGNOSTIC CATHETER BROKE DURING SHAPING. THE STRAIN RELIEF PORTION OF THE DEVICE BROKE DURING SHAPING, RESULTING IN A FRACTURE AND SEPARATION INTO MULTIPLE PIECES. THE SURGEON IMMEDIATELY STOPPED USING THE CATHETERS AND REPLACED THEM WITH ANOTHER NON-CORDIS CATHETER TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT OCCURRED DURING A PATENT DUCTUS ARTERIOSUS (PDA) SURGICAL PROCEDURE AFTER AN UNKNOWN GUIDEWIRE HAD BEEN REMOVED. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). SHAPING WAS PERFORMED OUTSIDE OF THE PATIENT, AND THE BREAKAGE ALSO OCCURRED OUTSIDE OF THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS CASE AS A SERIOUS INJURY ADVERSE EVENT TO THE CHINA NMPA. ADDENDUM: BOTH DEVICES WERE RETURNED WITH SEPARATIONS AT THE DISTAL TIP AND THE STRAIN RELIEFS FULLY INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582551 ↗
• MalfunctionMar 12, 2026Detachment of Device or Device Component

  AS REPORTED, A 6F MULTIPURPOSE (MP) A2 100CM INFINITI THRULUMEN DIAGNOSTIC CATHETER BROKE DURING SHAPING. THE CATHETER BODY FRACTURED AT THE JUNCTION BETWEEN THE DISTAL TIP AND THE CATHETER SHAFT DURING SHAPING, RESULTING IN A SEPARATION INTO MULTIPLE PIECES. THE SURGEON IMMEDIATELY STOPPED USING THE CATHETER AND REPLACED IT WITH ANOTHER NON-CORDIS CATHETER TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT OCCURRED DURING A PATENT DUCTUS ARTERIOSUS (PDA) SURGICAL PROCEDURE AFTER AN UNKNOWN GUIDEWIRE HAD BEEN REMOVED. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). SHAPING WAS PERFORMED OUTSIDE OF THE PATIENT, AND THE BREAKAGE ALSO OCCURRED OUTSIDE OF THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS CASE AS A SERIOUS INJURY ADVERSE EVENT TO THE CHINA NMPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582418 ↗
• MalfunctionFeb 6, 2026Detachment of Device or Device Component

  AS REPORTED, A 6F 100CM MULTIPURPOSE (MPA) 2 TWO SIDE-HOLE INFINITI DIAGNOSTIC CATHETERS FRACTURED AT THE STRAIN RELIEF, APPROXIMATELY 8.5 CM FROM THE DISTAL TIP DURING ROUTINE SHAPING AT THE TIP OF THE CATHETER, AND IT WAS FOUND THAT THERE WAS NO STEEL WIRE BRAID LAYER IN THE STRAIN RELIEF. THE DEVICE DID NOT ENTER THE PATIENT AND ANOTHER 6F 100CM MPA2 TWO SIDE-HOLE INFINITI DIAGNOSTIC CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE LUER HUB DID NOT SEPARATE FROM THE STRAIN RELIEF. THE DEVICE WAS STORED AND PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280048 ↗
• MalfunctionJan 14, 2026Detachment of Device or Device Component

  AS REPORTED, A 6F .070-INCH MULTIPURPOSE (MP) A2 100CM INFINITI DIAGNOSTIC CATHETER WAS FOUND TO BE SEPARATED UPON OPENING, WHEN THE OPERATOR WAS PREPARING TO START THE PROCEDURE. UPON OPENING THE INNER PACKAGE, THE SEPARATION OF THE TUBE BODY WAS OBSERVED. THE REPORTED ISSUE DESCRIBED AS ¿BROKEN¿ REFERRED TO THE CATHETER HEAD END BEING SEPARATED FROM THE TUBE BODY WHEN THE PACKAGE WAS OPENED. ANOTHER INFINITI CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). UPON OPENING THE INNER PACKAGE, THE SEPARATION OF THE TUBE BODY WAS OBSERVED. THE INNER PACKAGE WAS TORN OPEN, AND THE CARDBOARD WAS ATTACHED TOGETHER WITH THE CATHETER. NO OTHER DAMAGE WAS NOTED. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071542 ↗
• MalfunctionJan 14, 2026Detachment of Device or Device Component

  AS REPORTED, A 6F .070-INCH MULTIPURPOSE (MP) A2 100CM INFINITI DIAGNOSTIC CATHETER WAS FOUND TO BE SEPARATED UPON OPENING, WHEN THE OPERATOR WAS PREPARING TO START THE PROCEDURE. UPON OPENING THE INNER PACKAGE, THE SEPARATION OF THE TUBE BODY WAS OBSERVED. THE REPORTED ISSUE DESCRIBED AS ¿BROKEN¿ REFERRED TO THE CATHETER HEAD END BEING SEPARATED FROM THE TUBE BODY WHEN THE PACKAGE WAS OPENED. ANOTHER INFINITI CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). UPON OPENING THE INNER PACKAGE, THE SEPARATION OF THE TUBE BODY WAS OBSERVED. THE INNER PACKAGE WAS TORN OPEN, AND THE CARDBOARD WAS ATTACHED TOGETHER WITH THE CATHETER. NO OTHER DAMAGE WAS NOTED. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WILL BE RETURNED FOR EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067820 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  AS REPORTED, FORTY-FIVE 6F MP A2 INFINITI CATHETERS WERE FOUND TO BE BROKEN IMMEDIATELY UPON OPENING THE PACKAGE. WHEN UNPACKING, IT WAS FOUND THAT THE HEAD END AND THE TUBE BODY HAD BEEN SPITED. ALL 45 CATHETERS WERE CONFIRMED TO HAVE THE SAME MALFUNCTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICES WERE REMOVED BY TEARING THE INNER PACKAGE, AND REMOVING THE CATHETER AND CARDBOARD TOGETHER. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050025 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  AS REPORTED, FORTY-FIVE 6F MP A2 INFINITI CATHETERS WERE FOUND TO BE BROKEN IMMEDIATELY UPON OPENING THE PACKAGE. WHEN UNPACKING, IT WAS FOUND THAT THE HEAD END AND THE TUBE BODY HAD BEEN SPITED. ALL 45 CATHETERS WERE CONFIRMED TO HAVE THE SAME MALFUNCTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICES WERE REMOVED BY TEARING THE INNER PACKAGE AND REMOVING THE CATHETER AND CARDBOARD TOGETHER. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050015 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  AS REPORTED, FORTY-FIVE 6F MP A2 INFINITI CATHETERS WERE FOUND TO BE BROKEN IMMEDIATELY UPON OPENING THE PACKAGE. WHEN UNPACKING, IT WAS FOUND THAT THE HEAD END AND THE TUBE BODY HAD BEEN SPITED. ALL 45 CATHETERS WERE CONFIRMED TO HAVE THE SAME MALFUNCTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICES WERE REMOVED BY TEARING THE INNER PACKAGE, AND REMOVING THE CATHETER AND CARDBOARD TOGETHER. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050004 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  AS REPORTED, FORTY-FIVE 6F MP A2 INFINITI CATHETERS WERE FOUND TO BE BROKEN IMMEDIATELY UPON OPENING THE PACKAGE. WHEN UNPACKING, IT WAS FOUND THAT THE HEAD END AND THE TUBE BODY HAD BEEN SPITED. ALL 45 CATHETERS WERE CONFIRMED TO HAVE THE SAME MALFUNCTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICES WERE REMOVED BY TEARING THE INNER PACKAGE AND REMOVING THE CATHETER AND CARDBOARD TOGETHER. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050000 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  AS REPORTED, FORTY-FIVE 6F MP A2 INFINITI CATHETERS WERE FOUND TO BE BROKEN IMMEDIATELY UPON OPENING THE PACKAGE. WHEN UNPACKING, IT WAS FOUND THAT THE HEAD END AND THE TUBE BODY HAD BEEN SPITED. ALL 45 CATHETERS WERE CONFIRMED TO HAVE THE SAME MALFUNCTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICES WERE REMOVED BY TEARING THE INNER PACKAGE, AND REMOVING THE CATHETER AND CARDBOARD TOGETHER. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049964 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  AS REPORTED, FORTY-FIVE 6F MP A2 INFINITI CATHETERS WERE FOUND TO BE BROKEN IMMEDIATELY UPON OPENING THE PACKAGE. WHEN UNPACKING, IT WAS FOUND THAT THE HEAD END AND THE TUBE BODY HAD BEEN SPITED. ALL 45 CATHETERS WERE CONFIRMED TO HAVE THE SAME MALFUNCTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICES WERE REMOVED BY TEARING THE INNER PACKAGE, AND REMOVING THE CATHETER AND CARDBOARD TOGETHER. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049947 ↗

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