NA RFDEUK-10Recalls & reported problems

St. Jude Medical, Inc. · Disposable Radiofrequency Electrode · Class 2

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067028990), received between Sep 1, 2022 and Sep 1, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low impedance” (6 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

Device problems

Low impedance6

Patient problems

No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

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

MalfunctionSep 1, 2022Low impedance; Low impedance
RELATED MANUFACTURER REPORT NUMBERS: 2184149-2022-00197, 2184149-2022-00198, 2184149-2022-00199, 2184149-2022-00200, 2184149-2022-00201, 2184149-2022-00202. DURING THE PROCEDURE, THERE WAS A MISSING IMPEDANCE ERROR MESSAGE, AND THE GENERATOR STOPPED WORKING AFTER THE SENSORY AND MOTOR TESTING. THE PROCEDURE COULD NOT BE COMPLETED. HOWEVER AFTER THE PROCEDURE, DURING TROUBLESHOOTING, THE ELECTRODE WAS REPLACED AND THE GENERATOR WAS FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337392 ↗
MalfunctionSep 1, 2022Low impedance; Low impedance
RELATED MANUFACTURER REPORT NUMBERS: 2184149-2022-00197, 2184149-2022-00198, 2184149-2022-00200, 2184149-2022-00201, 2184149-2022-00202, 2184149-2022-00203. DURING THE PROCEDURE, THERE WAS A MISSING IMPEDANCE ERROR MESSAGE, AND THE GENERATOR STOPPED WORKING AFTER THE SENSORY AND MOTOR TESTING. THE PROCEDURE COULD NOT BE COMPLETED. HOWEVER AFTER THE PROCEDURE, DURING TROUBLESHOOTING, THE ELECTRODE WAS REPLACED AND THE GENERATOR WAS FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337360 ↗
MalfunctionSep 1, 2022Low impedance; Low impedance
RELATED MANUFACTURER REPORT NUMBERS: 2184149-2022-00197, 2184149-2022-00198, 2184149-2022-00199, 2184149-2022-00200, 2184149-2022-00202, AND 2184149-2022-00203. DURING THE PROCEDURE, THERE WAS A MISSING IMPEDANCE ERROR MESSAGE, AND THE GENERATOR STOPPED WORKING AFTER THE SENSORY AND MOTOR TESTING. THE PROCEDURE COULD NOT BE COMPLETED. HOWEVER AFTER THE PROCEDURE, DURING TROUBLESHOOTING, THE ELECTRODE WAS REPLACED AND THE GENERATOR WAS FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337331 ↗
MalfunctionSep 1, 2022Low impedance; Low impedance
RELATED MANUFACTURER REPORT NUMBERS: 2184149-2022-00197, 2184149-2022-00198, 2184149-2022-00199. 2184149-2022-00201, 2184149-2022-00202, 2184149-2022-00203. DURING THE PROCEDURE, THERE WAS A MISSING IMPEDANCE ERROR MESSAGE, AND THE GENERATOR STOPPED WORKING AFTER THE SENSORY AND MOTOR TESTING. THE PROCEDURE COULD NOT BE COMPLETED. HOWEVER AFTER THE PROCEDURE, DURING TROUBLESHOOTING, THE ELECTRODE WAS REPLACED AND THE GENERATOR WAS FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337325 ↗
MalfunctionSep 1, 2022Low impedance; Low impedance
RELATED MANUFACTURER REPORT NUMBERS: 2184149-2022-00197, 2184149-2022-00198, 2184149-2022-00199, 2184149-2022-00200, 2184149-2022-00201, 2184149-2022-00203. DURING THE PROCEDURE, THERE WAS A MISSING IMPEDANCE ERROR MESSAGE, AND THE GENERATOR STOPPED WORKING AFTER THE SENSORY AND MOTOR TESTING. THE PROCEDURE COULD NOT BE COMPLETED. HOWEVER AFTER THE PROCEDURE, DURING TROUBLESHOOTING, THE ELECTRODE WAS REPLACED AND THE GENERATOR WAS FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337319 ↗
MalfunctionSep 1, 2022Low impedance; Low impedance
RELATED MANUFACTURER REPORT NUMBERS: 2184149-2022-00197, 2184149-2022-00199, 2184149-2022-00200, 2184149-2022-00201, 2184149-2022-00202, 2184149-2022-00203. DURING THE PROCEDURE, THERE WAS A MISSING IMPEDANCE ERROR MESSAGE, AND THE GENERATOR STOPPED WORKING AFTER THE SENSORY AND MOTOR TESTING.THE PROCEDURE COULD NOT BE COMPLETED. HOWEVER, AFTER THE PROCEDURE, DURING TROUBLESHOOTING, THE ELECTRODE WAS REPLACED AND THE GENERATOR WAS FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337288 ↗

Device details

UDI-DI	`05415067028990`
Brand	NA
Model	RFDEUK-10
Company	St. Jude Medical, Inc.
Product code	GXI · PROBE, RADIOFREQUENCY LESION
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2023

Device type (GMDN): Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

A hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under external image guidance or using electrical stimulation for nerve location] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula or a tubing set to allow fluid cooling of the electrode may be included. This is a single-use device.

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All PROBE, RADIOFREQUENCY LESION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.