DxTerity™ TRA U5TRAN45SHARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169738959), received between Jun 8, 2017 and Jun 8, 2017 — classified as 1 injury.

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

• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED A DXTERITY GUIDE CATHETER WHEN TREATING THE RCA (OSTIUM/ PROXIMAL/ MID). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE CATHETER. THE CATHETER WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE CATHETER WAS PREPPED WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE GC, EXCESSIVE FORCE WAS NOT USED. THE RCA HAD NO CALCIFICATION, NO TORTUOSITY. WHEN THE PHYSICIAN WENT TO ENGAGE THE CATHETER, A SPIRAL DISSECTION OCCURRED IN THE OSTIUM TO MID VESSEL , CAUSED BY THE DIAGNOSTIC CATHETER WHEN IT ENGAGED THE SLIGHTLY ANTERIOR TAKE OFF OF THE RCA. THE DISSECTION WAS TREATED WITH TWO DRUG-ELUTING STENTS. NO SPECIFIC MALFUNCTION REPORTED BUT THE PHYSICIAN SAID THE STIFFNESS OF THE TIP OF THE DXTERITY IS MORE THAN LIKELY THE CAUSE. THERE IS NO ALLEGED PRODUCT ISSUE. NO ADDITIONAL PATIENT CLINICAL SEQUELAE REPORTED.

  Patient problems: Intimal Dissection; Patient Problem/Medical Problem

  MAUDE report 6621801 ↗

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.