NA TCD-10-3MRecalls & reported problems

Boston Scientific Neuromodulation Corporation · Disposable TC Electrode, 10cm, 3m Cable · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813250014365), received between Jan 5, 2024 and Jan 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Heating” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Heating1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 5, 2024Insufficient Heating; Insufficient Heating
IT WAS REPORTED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE, THE PATIENT WAS ADMINISTERED GENERAL ANESTHESIA; HOWEVER, THE ELECTRODE DID NOT HEAT TO THE CORRECT TEMPERATURE AND THE PROCEDURE WAS UNABLE TO BE PERFORMED. THERE WERE NO PATIENT COMPLICATIONS DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18452423 ↗

Device details

UDI-DI	`00813250014365`
Brand	NA
Model	TCD-10-3M
Company	Boston Scientific Neuromodulation Corporation
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	Oct 8, 2018

Device type (GMDN): Radio-frequency ablation system

An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

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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.