DxTerity™ TRA U6TRAP40SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169738577), received between Apr 21, 2017 and Apr 21, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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.

• InjuryApr 21, 2017Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN INTENDED TO USE A DXTERITY DIAGNOSTIC CATHETER. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED. THE PHYSICIAN NOTICED OVALIZATION OF THE TIP PRIOR TO INSERTION IN PATIENT. THE INTENDED LESION WAS IN THE PROXIMAL RCA, NON-TORTUOUS, SEVERE CALCIFICATION AND (B)(6) STENOSIS. THE VESSEL HAD CALCIFIED ECCENTRIC PLAQUE. A DISSECTION OCCURRED DURING THE PROCEDURE. THE PHYSICIAN WAS NOT SURE IF THE DXTERITY CATHETER CAUSED THE DISSECTION, OR IF IT WAS JUST ECCENTRIC PLAQUE. THE VESSEL WAS IVUSED TO LOOK AT THE POSSIBLE DISSECTION BUT THE DETERMINATION WAS UNCLEAR. THE LESION WAS FFR AT (B)(6) NEGATIVE. WHEN THE POSSIBLE DISSECTION AFTER DIAGNOSTIC CATH WAS NOTED ON ANGIO REVIEW, AND WITH THE UNCERTAIN IVUS RESULT, THE DECISION WAS MADE TO STENT THE DISSECTION. NO ADDITIONAL PATIENT CLINICAL SEQUELAE REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 6511096 ↗

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.