Dynamic XT™ M0042011020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729877622), received between Jun 1, 2021 and Oct 18, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 18, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  THE DYNAMIC XT ELECTRODE CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE. IT WAS REPORTED THAT WHEN THE OUTER PACKAGE OF THE DEVICE WAS REMOVED, THEY FOUND THE PLASTIC PROTECTIVE SLEEVE OUTSIDE THE CATHETER WAS FRACTURED. THE DEVICE WAS CONTAMINATED AND COULD NOT BE USED DUE TO DAMAGE TO THE PROTECTIVE SLEEVE. CATHETER WAS REPLACED WITH A NEW ONE FROM THE SAME MODEL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488681 ↗
• MalfunctionAug 10, 2024Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ABLATION PROCEDURE TO TREAT A SUPRAVENTRICULAR TACHYCARDIA (SVT), A DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER WAS SELECTED FOR USE. ON OPENING STERILE PACKAGING, SCOUT NURSE IDENTIFIED A SMALL FIBER THAT APPEARED TO REPRESENT A HAIR/STRAND OF GLUE ATTACHED NEAR A JOIN TOWARD THE END OF THE BLACK SECTION OF THE HANDLE. DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19957764 ↗
• MalfunctionJun 18, 2024Packaging Problem; Packaging Problem

  THE DYNAMIC XT ELECTRODE CATHETER WAS SELECTED FOR A ABLATION PROCEDURE. PRIOR TO USE, IT WAS NOTED THAT THE PLASTIC OUTER PACKAGING OF THE DEVICE WAS DAMAGED AND NO LONGER STERILE. THE DEVICE WAS REPLACED WITH A NEW ONE FROM THE SAME MODEL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. IT IS UNKNOWN IF DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559727 ↗
• MalfunctionJul 6, 2023Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE USING A DYNAMIC XT CATHETER THE SHAFT OF THE SHEATH WAS BROKEN. THEY EXCHANGED THE CATHETER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS THEN COMPLETED WITH NO PATIENT COMPLICATIONS. THE CATHETER HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270174 ↗
• InjuryDec 8, 2022Difficult to Remove; Difficult to Remove

  DURING A RADIOFREQUENCY ABLATION PROCEDURE, A DYNAMIC XT ELECTRODE CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT WHEN THE CATHETER WAS DELIVERED INTO THE BRANCH OF THE VEIN, VENOUS CONTRACTURE OCCURRED, AND THE CATHETER COULD NOT BE WITHDRAWN. THE PHYSICIAN WAS EVENTUALLY ABLE TO REMOVE THE CATHETER, AND A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO DAMAGE OR PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vasoconstriction

  MAUDE report 15941100 ↗
• MalfunctionJun 1, 2021Difficult to Remove; Defective Device; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT A DYNAMIC XT ELECTRODE CATHETER WAS USED IN A TACHYCARDIA ELECTROPHYSIOLOGICAL EXAMINATION AND RADIOFREQUENCY ABLATION PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD A SEVERELY TORTUOUS LEFT FEMORAL VEIN. UPON ADVANCING TO THE JUNCTION OF RIGHT FEMORAL VEIN AND INFERIOR VENA CAVA THE BLOOD VESSEL HAD ANGULATION OF 90 DEGREES. AFTER PUSHING THOUGHT THE ANGULATION THE CATHETER BECAME STUCK AND WAS DAMAGED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE CATHETER'S FAILURE WAS THAT THE CATHETER WAS UNABLE TO BEND. THE CATHETER WAS REMOVED BY SIMPLY PULLING THE CATHETER OUT WITHOUT INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913507 ↗