N/A (REF 81105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885825009564), received between Jun 6, 2019 and Aug 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Use of Device Problem; Deformation Due to Compressive Stress; Use of Device Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER CAME OUT OF THE BOX CURVY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22820139 ↗
• MalfunctionJul 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE DEVICE CURVE WAS WARPED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313041 ↗
• MalfunctionFeb 4, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, TIP DEFLECTOR NOT WORKING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282279 ↗
• MalfunctionJun 6, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS DEFECTIVE. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675335 ↗