DxTerity™ DXT5JL35 (UDI 00643169689299)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169689299), received between Mar 1, 2021 and Feb 14, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 5F DXTERITY DIAGNOSTIC CATHETER DURING A CORONARY ANGIOGRAPHY PROCEDURE. THE DEVICE WAS NOT INSPECTED BEFORE USE. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT WHEN PUSHING THE NON-MEDTRONIC GUIDEWIRE INTO THE DXTERITY CATHETER IT WAS FOUND THAT THE DXTERITY CATHETER WAS INCOMPLETELY BROKEN FROM THE OPENING CONNECTOR. THE DEVICE TIP WAS NOTED TO BE CRACKED/DAMAGED DURING PROCEDURE. DURING THE OPERATION THE DXTERITY DEVICE AND THE GUIDEWIRE HAD ENTERED THE BLOOD VESSEL AND UNDER FLUOROSCOPY IT WAS FOUND THAT THE TIP OF THE DXTERITY WAS DAMAGED. HOWEVER, THE DEVICE DID NOT CAUSE ANY DAMAGE TO THE PATIENT'S BLOOD VESSELS. THE TIP DID NOT BREAK INTO SEPARATE PARTS, THE WHITE PART OF THE TIP END WAS CRACKED. IT WAS DETAILED THAT DURING THE USE OF DEVICE, THE TIP END COULD NOT BE CONNECTED TO THE OTHER DEVICES. THERE WAS NO PROBLEM WITH THE CONNECTOR AND NO DAMAGE TO THE LUER. THE NON-MEDTRONIC GUIDEWIRE WAS INSERTED FROM THE TIP END. NO DEVICE OR CONNECTOR WAS ATTACHED TO THE DXTERITY. THE DEVICE WAS REPLACED WITH A NEW MEDTRONIC DXTERITY DEVICE WITH NO ISSUES. THE CONNECTOR WAS SUCCESSFULLY CONNECTED WITH THE REPLACEMENT ANGIOG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703940 ↗
• MalfunctionMar 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE 5 FRENCH DXTERITY CATHETER TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 60% STENOSIS LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. THE CATHETER WAS DELIVERED OVER A .035 WIRE AND ENGAGED IN THE LEFT MAIN. IT WAS REPORTED THAT WHEN ATTEMPTING TO MOVE THE CATHETER TO A BETTER POSITION, IT WAS NOTICED ON FLURO THAT THE TIP OF THE CATHETER WAS HANGING THE MAIN PORTION OF THE CATHETER, THE TIP WAS NOT FULLY DETACHED. THE CATHETER ALONG WITH THE TIP WAS REMOVED FROM THE PATIENT BY SLOWLY REMOVING THE DEVICE. IT WAS STATED THAT THE CATHETER HAD TO PASS RIGHT BY THE CAROTID ARTERY (RADIAL CASE). THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391606 ↗

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.