INFINITI 534643TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032014311), received between Nov 6, 2023 and Nov 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE CATHETER TIP OF A 6F INFINITI CATHETER AMPLATZ RIGHT (AR) 2 100 CM WAS TORN DURING WITHDRAWAL OF THE CATHETER. THE DISTAL TIP BECAME SEPARATED FROM THE CATHETER DURING USE AND WAS NOTED UPON REMOVAL FROM THE PATIENT. THE DAMAGE WAS REPORTED AS SEPARATED AND FRAYED/SPLIT /TORN. THE TORN TIP WAS SECURED BY A LOOP (THERE WAS A KINK AT THE TIP THAT RESULTED FROM THE LOOP). THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE ACCESS SITE WAS RADIAL, AND THE TARGET LESION WAS IN THE RIGHT CORONARY. LESION CALCIFICATION AND VESSEL TORTUOSITY WAS MILD WITH LESS THAN TWENTY-FIVE PERCENT (25%) STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PATIENT WAS NOT HOSPITALIZED OR REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THIS EVENT. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072532 ↗

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