INFINITI 534550SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705032013918), received between Sep 9, 2021 and Feb 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, FOREIGN MATERIAL WAS OBSERVED DURING INTRA-PROCEDURAL FLUSHING OF A 5F INFINITI PIGTAIL (PIG) 110CM 6SIDE HOLES (SH) DIAGNOSTIC CATHETER AFTER OPENING THE PRODUCT PACKAGING. THE DEVICE WAS REPLACED WITH NEW UNKNOWN ANGIOGRAPHIC CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE FOREIGN MATERIAL WAS NOT RETAINED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339934 ↗
• MalfunctionJul 8, 2025Leak/Splash; Leak/Splash

  AS REPORTED, THE HUB OF A 5F 110 CM INFINITI PIGTAIL DIAGNOSTIC CATHETER WAS NOT SEALING AND WAS BLEEDING. NORMAL RESISTANCE WAS ENCOUNTERED DURING INSERTION; HOWEVER, BLEEDING WAS OBSERVED DURING BOTH ADVANCEMENT AND WITHDRAWAL OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A CORONARY ANGIOPLASTY, AND A RADIAL APPROACH WAS USED. AT THE TARGET SITE, THE VESSEL EXHIBITED MODERATE CALCIFICATION, NO TORTUOSITY, AND APPROXIMATELY 60% STENOSIS. THERE WERE NO ACUTE ANGLES OR BIFURCATIONS NOTED. AT THE ACCESS SITE, THE VESSEL SHOWED NO CALCIFICATION, TORTUOSITY, STENOSIS, ACUTE ANGLES, OR BIFURCATIONS. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB AND WAS TORQUED OR STEERED USING THE HUB. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE, AND THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM STERILE PACKAGING. THE DEVICE WAS PREPPED ACCORDING TO THE IFU, AND NO UNUSUAL FORCE WAS USED DURING THE PROCEDURE. THE DEVICE WAS NOT RETURNED AS ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441451 ↗
• MalfunctionJul 7, 2025Crack; Material Fragmentation; Crack; Material Fragmentation

  AS REPORTED, THE USER DETECTED A DEFECTIVE HUB ON THE 5F 110CM 6 SIDE-HOLE (SH) INFINITI DIAGNOSTIC CATHETER. TWO IMAGES OF THE LUER HUB WERE PROVIDED, WHICH APPEAR TO SHOW SIGNS CONSISTENT WITH A POTENTIAL CRACK AND SPLINTERING. A RED LINE IS VISIBLE EXTENDING FROM THE PROXIMAL PORTION OF THE HUB TOWARD THE DISTAL END, WHICH MAY SUGGEST THAT THE HUB WAS CONNECTED TO A PATIENT AND THAT BLOOD MAY HAVE TRAVELED THROUGH A CRACK IN THE COMPONENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409247 ↗
• MalfunctionOct 12, 2023Partial Blockage; Partial Blockage

  AS REPORTED, AFTER CATHETER FLUSHING AND REVIEW, THE STAFF RECORDED THAT A 5F 110CM 6 SIDE HOLES (6SH) INFINITI DIAGNOSTIC PIGTAIL CATHETER DID NOT CONTAIN THE SIDE HOLES AS USUAL. THE CATHETER WAS NOT INTRODUCED IN THE PATIENT AND WAS MARKED AS A CLAIM/ADVERSE EVENT. THE INTENDED PROCEDURE WAS REPORTED TO BE A PERCUTANEOUS CORONARY INTERVENTION (PCI) CATHETERIZATION. ANOTHER UNKNOWN DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE MEDICAL STAFF TOOK THE PROCEDURE AS PER THE INSTRUCTION FOR USE (IFU). ON THE PREPARING TABLE THE DEVICE WAS FLUSHED WITH COLD SALINE DURING HANDLING IN ACCORDANCE WITH THE IFU AND THE DEVICE DID NOT CONTAIN SIDE HOLES. THE PRODUCT WAS STORED ACCORDING TO THE IFU. THE PACKAGING OF THE MEDICAL DEVICE WAS WITHOUT ANY DEFECT AND THE STERILE PACKAGING WAS WITHOUT ANY DAMAGE. BEFORE INTRODUCING IT TO THE PATIENT, VISUAL CONTROL OF THE INFINITI CATHETER WAS PERFORMED. THE COMPLAINT DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE EVENT WAS REPORTED BY THE HOSPITAL TO THE LOCAL COMPETENT AUTHORITY (CA) AS AN ADVERSE EVENT. DEVICE PICTURES WERE RECEIVED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926535 ↗
• MalfunctionDec 10, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, A PHYSICIAN WAS PERFORMING A LEFT HEART CATHERIZATION. WHEN RETRACTING A 6CATH F5 INF PIG 110CM 6SH INFINITI GUIDING CATHETER, IT COULD NOT RETRACT ALL THE WAY OUT OF THE SHEATH. IT FELT STUCK ON THE DISTAL END OF THE SHEATH. AFTER ADVANCING IT AND RETRACTING IT MULTIPLE TIMES, HE WAS ABLE TO RETRACT ALL THE WAY OUTSIDE OF THE SHEATH FOR COMPLETE REMOVAL. PATIENT WAS NOT HARMED BY THIS DURING THE PROCEDURE AND NO REACTION FROM PATIENT. THE PHYSICIAN INSPECTED THE DEVICE AND NOTICED A KINK IN IT WHICH HE HAS NEVER SEEN BEFORE. THE PHYSICIAN WANTED IT INSPECTED. STAFF SAID THAT HE WAS IN A HURRY AND WAS JUST RETRACTING IT REAL FAST AND MAY HAVE OVER TORQUED IT CAUSING THE KINK. THE DEVICE WAS OPENED IN A STERILE FIELD AND STORED AS PER THE INSTRUCTIONS FOR USE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977434 ↗
• MalfunctionSep 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 5F 110CM 6 SIDE HOLES (6SH) INFINITI PIGTAIL (PIG) DIAGNOSTIC CATHETER WAS BROKEN IN HALF WHEN IT WAS REMOVED FROM THE PACKAGING. IN ADDITION, THE PACKAGING WAS ALSO BROKEN. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451499 ↗

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