ADROIT 67227800Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032065372), received between Jun 18, 2021 and Jun 18, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, A 6F .072¿ 100CM HOCKEY STICK (H-STICK) ADROIT GUIDING CATHETER GOT STUCK INSIDE A PATIENT. THE PATIENT¿S GROIN WAS VERY TORTUOUS AND THE ADROIT COILED UP AND WILL NOT COME OUT. THE PATIENT WAS TAKEN INTO SURGERY WHERE A CUT DOWN WAS PERFORMED TO REMOVE THE GUIDING CATHETER. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE NOR WERE THERE ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE INTENDED PROCEDURE/TARGET LESION WAS LEFT HEART CATH. VESSEL TORTUOSITY WAS MODERATE TO SEVERE. THE DEVICE WAS NOT RESTERILIZED. THE CURRENT PATIENT OF THE PATIENT IS STABLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026309 ↗

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.