ADROIT 67203400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032065266), received between Jan 26, 2023 and Feb 20, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED IN THE MEDWATCH REPORT, AN ADROIT 6F AMPLATZ LEFT 0.75 GUIDE CATHETER (GC) KINKED WHILE IN THE PATIENT. THE DEVICE WAS REMOVED IN ONE PIECE. IT IS STATED THAT THE REASON THAT THE CATHETER WAS SNARED OUT WAS BECAUSE THE USER INITIALLY TRIED TO REMOVE IT OVER AN UNKNOWN GUIDE WIRE BUT HAD DIFFICULTY. SO, IT WAS DECIDED TO SNARE THE GC. THE USER WAS ABLE TO REMOVE THE DEVICE BY SNARING IT OUT. A SNARE WAS REQUIRED TO BE USED TO RETRIEVE THE "BROKEN" PIECE FROM THE PATIENT. THE DEVICE WAS BENT. NO FURTHER HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THERE WAS NO EVIDENCE OF INJURY TO THE PATIENT NOTED. THE DEVICE WAS USED IN THE ELECTROPHYSIOLOGY LAB FOR A CATHETERIZATION PROCEDURE FOR STENT PLACEMENT. THE DEVICE KINKED IN THE RIGHT FEMORAL ARTERY. THE INTENDED TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS OCCLUDED WITH NO TORTUOSITY. THE DEVICE WAS NOT RESTERILIZED. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. THERE WAS NO EXCESSIVE TORQUEING REQUIRED. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WAS STORED AND PREPPED PER INSTRUCTIONS FOR USE (IFU). OTHER PROCEDURAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404884 ↗
• MalfunctionJan 26, 2023Material Twisted/Bent

  CORDIS 6FR AL 0.75 GUIDE CATHETER USED IN CATHETERIZATION PROCEDURE WAS NOTED BY DOCTOR TO BE KINKED WHILE IN PATIENT. DOCTOR WAS ABLE TO REMOVE BY SNARING DEVICE OUT.

  Patient problems: Failure of Implant

  MAUDE report 16245700 ↗

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.