DxTerityRecalls & reported problems across all models

We found 6 models of DxTerity by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2021 and Jun 12, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DxTerity recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 13, 2018Terminated

   The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.

   Z-1479-2018 · Root cause: Packaging · Recall details · FDA record ↗

Most reported DxTerity problems

DxTerity models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DxTerity™ DXT5JL40

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 recall0 reports
• DxTerity™ DXT5JL35

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 reports
• DxTerity™ DXT6JL40

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ DXT5JR40

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ DXT5PIGSTA

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• DxTerity™ DXT5JL35

  Catheter, intravascular, diagnostic
  1 report

Recent DxTerity adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2024Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE DXTERITY DIAGNOSTIC CATHETER DURING A PROCEDURE. THE DEVICE WAS REMOVED FROM THE PACKAGING AND PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS A TEAR/HOLE IN THE TIP OF THE CATHETER. ONCE THE TEAR/HOLE WAS NOTICED THE DEVICE WAS REMOVED AND REPLACE WITH ANOTHER CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19517961 ↗
• 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 21, 2022Use of Device Problem; Use of Device Problem

  A DXTERITY DIAGNOSTIC CATHETER WAS USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS NOT INSPECTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE WAS USED IN THE PATIENT AFTER IT HAD EXPIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838203 ↗
• 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 ↗
• MalfunctionAug 18, 2021Use of Device Problem; Use of Device Problem

  A DEXTERITY CORONARY DIAGNOSTIC CATHETER WAS USED TO TREAT A LESION IN THE RCA. THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE WAS EXPIRED WHEN USED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335394 ↗
• 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 ↗

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