DxTerity™ DXT5JR40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169689350), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K161287); 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.

• MalfunctionSep 21, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO DEXTERITY CATHETERS TO TREAT A LESION IN THE RCA AND LM ARTERIES. THERE WAS NO DAMAGE NOTED TO EITHER DEVICE. DEVICES WERE REMOVED FROM THE PACKAGING PER IFU. THERE WAS NO RESISTANCE NOTED WHILE REMOVING THE DEVICES FROM PACKAGING. A BRACHIAL APPROACH WAS USED FOR THE PROCEDURE. THE DEVICES WERE INSPECTED WITH ISSUES NOTED. THE FIRST DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT THIS DEVICE WAS KINKED IN THE MIDDLE OF THE CATHETER. THE KINK OCCURRED WHILE THE DEVICE WAS IN THE PATIENT. EXCESSIVE FORCE WAS NOT USED AND THE DEVICE WAS NOT EXCESSIVELY TORQUED. RESISTANCE WAS NOT EXPERIENCED. IT WAS REPORTED THAT THE SECOND DEVICE SEEMED TO BE KINKED. THE KINK WAS NOTED ON THE DEVICE SHAFT WHILE TORQUING THE CATHETER TO ENGAGE THE ARTERY. THE DEVICE WAS EXCESSIVELY TORQUED. RESISTANCE WAS NOT EXPERIENCED AND EXCESSIVE FORCE WAS NOT USED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161287. One submission often covers many models, so check the product and lot details in each record.

• Z-3253-2018 · Aug 16, 2018 · Terminated
  Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
• Z-1479-2018 · Mar 13, 2018 · Terminated
  Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.