DxTerity™ TRA U5ULTRA40SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000016753), received between Jul 10, 2020 and Jul 16, 2020 — classified as 2 injuries.

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 18, 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.

• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT A DXTERITY DIAGNOSTIC CATHETER WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT A DAMPING EFFECT WAS OBSERVED AFTER THE CONTRAST INJECTION DESPITE BEEN IN THE AORTA.

  Patient problems: Injury

  MAUDE report 10281732 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DXTERITY DIAGNOSIS CATHETER WAS USED DURING A PROCEDURE TO TREAT A NON TORTUOSITY, NONE CALCIFIED LESION IN THE MID ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A DAMPING EFFECT WAS OBSERVED AFTER THE CONTRAST INJECTION DESPITE BEEN IN THE AORTA. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Injury; Occlusion

  MAUDE report 10256712 ↗

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.