EP XT™ M0042010070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729877592), received between Nov 13, 2019 and Jul 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE CATHETER SHAFT EXHIBITED TEARS, RIPS, HOLES, AND SEPARATION OF DEVICE MATERIAL. AN EP-XT DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING PREPARATION, THE CABLE WAS FOUND TO BE RUPTURED, WITH EXPOSED WIRES AND LOOSENED SHEATHING. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645778 ↗
• MalfunctionOct 4, 2024Difficult to Remove; Difficult to Remove

  THE EP-XT STEERABLE DIAGNOSTIC CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE. IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED REQUIRING GENTLE TRACTION, THERE WAS A DISTAL INTERNAL FRACTURE, LEADING TO 90-DEGREE ANGULATION AND ENTRAPMENT INSIDE THE BODY. THE CARDIOLOGIST MANAGED TO GET THE CATHETER FREE, A NEW CATHETER WAS USED. D,F 3.5-MM MAPPING AND ABLATION CATHETER WAS INTRODUCED IN THE RIGHT ATRIUM (RA) AND WITH A MAPPING SYSTEM THE RA, RV AND CS WERE RECONSTRUCTED. SUBSEQUENTLY, UNDER ELECTROGRAM AND MAPPING SYSTEM GUIDANCE THERE WAS NO EVIDENCE OF ATRIAL ACTIVITY ACROSS THE CVTI. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATENT COMPLICATION WAS REPORTED. IT IS UNKNOWN IF DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20368639 ↗
• MalfunctionNov 13, 2019Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION OF THE EP-XT DIAGNOSTIC CATHETER, IT WAS NOTICED THAT THERE WAS A SMALL PIN HOLE IN THE STERILE PACKAGING. IT WAS ALSO NOTED THAT THE BENT/KINKED. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9314935 ↗