INFINITI 534650SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032014397), received between Feb 23, 2021 and Aug 15, 2025 — classified as 3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Degraded; Degraded

  AS REPORTED, THERE WAS CRACKING OF THE CASING NEAR THE HUB OF TWO 6F INFINITI PIGTAIL 110CM 6SH DIAGNOSTIC CATHETERS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NEVER USED. THE CRACKING WAS NOTICED BY SCRUB TECH AFTER OPENING PACKAGE. THREE IMAGES WERE PROVIDED FOR REVIEW. ONE OF THEM SHOWS A CATHETER WITH A STRAIN RELIEF THAT SHOWS SIGNS OF DEGRADATION. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822500 ↗
• MalfunctionJul 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THERE WAS A HAIR PRESENT IN THE ¿INNER PRODUCT¿ OF A 6F INFINITI VENTRICULAR STRAIGHT PIGTAIL SIDEHOLES 110CM DIAGNOSTIC CATHETER. THE ISSUE WAS OBSERVED IN THE LSP CUSTOM BONDED WAREHOUSE DURING INSPECTION AND AT THE TIME OF PASTING OVER LABELLING (INNER AND OUTER) PROCEDURE. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER INSTRUCTIONS FOR USE (IFU). IMAGE REVIEW WAS COMPLETED AND IMAGE ONE SHOWS THE .UTER BOX WITH LABEL STATING 6F 110CM INFINITI PIGTAIL CATHETER. THE SECOND IMAGE SHOWS THE TIP OF A PIGTAIL CATHETER INSIDE THE STERILE POUCH. A FOREIGN MATERIAL, WHICH LOOKS LIKE HAIR IS NOTED INSIDE THE POUCH. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121974 ↗
• MalfunctionFeb 23, 2021Crack; Crack

  WHEN USING A 6F 110CM 6 SIDE HOLES (6SH) INFINITI PIGTAIL DIAGNOSTIC CATHETER, IT WAS FOUND THAT THERE WAS A FRACTURE IN THE MIDDLE SECTION. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER UNKNOWN ANGIOGRAPHIC CATHETER TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT INJURY. ANGIOGRAPHY FOUND THAT THE RIGHT CORONARY ARTERY (RCA) HAD MORE THAN 80% STENOSIS AND NEEDED A PERCUTANEOUS CORONARY INTERVENTION (PCI) TREATMENT. THE RCA HAD MODERATE CALCIFICATION, MODERATE TORTUOSITY, AND MODERATE ANGULATION. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE USER WAS EXPERIENCED WITH THE DEVICE. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE WAS INSPECTED WHEN REMOVED FROM THE PACKAGE BEFORE IT WAS USED AND NO ANOMALIES WERE NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THERE WAS NO SEPARATION THAT HAD TO BE SNARED OUT. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OR WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THERE WAS NO EXCESSIVE TORQUEING REQUIRED. THE DEVICE DID NOT PREVIOUSLY KINK OR BEND IN THE AREA THAT CRACKED. THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364155 ↗

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