ADROIT 67205400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032065310), received between Dec 7, 2022 and Dec 7, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K131225); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2022Break; Material Frayed; Positioning Problem

  AS REPORTED, THE HEAD END OF A 6F .072 EXTRA BACK UP 3.5 100CM ADROIT GUIDING CATHETER WAS BROKEN. THE TIP OF THE CATHETER WAS FRAYED. THE ¿HEAD END¿ IS THE DISTAL TIP AND IT COULD NOT PASS THROUGH AN UNKNOWN 6F CORDIS RADIAL SHEATH. THE CATHETER WAS ¿NOT BROKEN¿ BUT NOTICED THE MALFUNCTION INSERTING INTO THE PATIENT. AN UNKNOWN GUIDE CATHETER WAS USED TO COMPLETE THE PROCEDURE. IT HAD NO IMPACT ON THE PATIENT AND THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO CALCIFICATION, TORTUOSITY, ACUTE ANGLE OR BIFURCATION OF THE TARGET VESSEL. THERE WAS A STENOSIS OF 80% AT THE TARGET VESSEL. THERE WAS NO CALCIFICATION, TORTUOSITY, STENOSIS, ACUTE ANGLE OR BIFURCATION ACCESSING THE TARGET VESSEL. THE DEVICE WAS USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS USED WITH A RADIAL APPROACH WITH NO CONTRALATERAL APPROACH. THE DEVICE WAS STORED AND PREPPED PER INSTRUCTIONS FOR USE (IFU). THE USER IS TRAINED TO THE DEVICE. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931948 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131225. One submission often covers many models, so check the product and lot details in each record.

• Z-0003-2014 · Aug 12, 2013 · Terminated
  Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.