ADROIT 67208200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032065402), received between Jan 21, 2019 and Mar 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

• MalfunctionMar 24, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THERE WAS A PRESENCE OF LEAKAGE (THE PRESENCE OF A MICROHOLE) TO THE PROXIMAL PART OF THE 6F ADROIT GUIDING CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE CARDIOLOGIST REALIZED IT WHEN INJECTING THE CONTRAST PRODUCT (LEAKAGE). A NEW DEVICE WAS USED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. PHOTOGRAPH WAS PROVIDED AND AVAILABLE FOR REVIEW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9873380 ↗
• MalfunctionJan 21, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED, THE BOX INDICATED THE DEVICE WAS 6F .072 JR 4 100CM ADROIT GUIDING CATHETER BUT INSIDE THERE WAS A JR4 SH GUIDING CATHETER INSTEAD. THE DEVICE WAS USED ON THE PATIENT. THE DEVICE WAS STORED AS PER THE LABELING AND WAS OPENED IN A STERILE FIELD. THE DEVICE WAS NOT USED A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DAMAGE TO THE OUTER PACKAGING. THE SEAL OF THE STERILE POUCH INSIDE WAS OPENED, PRIOR TO NOTICING THE DIFFERENT DEVICE AND THE ACTUAL PRODUCT WAS NOT DAMAGED. THE PACKAGE WAS OPENED BEFORE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8265340 ↗

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.