ETHICON Linx Esophagus Sizing Tool LSTRecalls & reported problems

Torax Medical, Inc. · ETHICON Linx Esophagus Sizing Tool · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10855106005438), received between Oct 13, 2021 and May 8, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 18, 2026.

Most reported problems

Device problems

Contamination /Decontamination Problem1
Insufficient Device Problem Information1

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMay 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A PARA ESOPHAGEAL HERNIA REPAIR WITH MSA PROCEDURE THE MAGNETIC COMPONENT THAT NORMALLY STANDS UP WAS LAYING ON THE SIDE. THEY ENDED UP DOING REPAIR WITH A WATSON INSTEAD OF A LINX. PATIENT IS BEING KEPT OVERNIGHT.
Patient problems: Insufficient Information
MAUDE report 16885200 ↗
MalfunctionOct 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT DURING A LINX IMPLANT WHEN THEY OPENED THE DEVICE IT HAD A FOREIGN METAL OBJECT ATTACHED TO IT. IT WAS REMOVED AND THE DEVICE WAS IMPLANTED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12622928 ↗

Device details

UDI-DI	`10855106005438`
Brand	ETHICON Linx Esophagus Sizing Tool
Model	LST
Company	Torax Medical, Inc.
Product code	QJN · Laparoscopic accessories, esophageal sizing
Class	Class 2
FDA submission	K201035
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 31, 2020

Device type (GMDN): Gastro-oesophageal antireflux prosthesis

An implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. It typically consists of a toroidal, C-shaped elastomer ring filled with a silicone gel that includes a polyester tie to secure the ring around the gastro-oesophageal junction; it is intended for surgical implantation under the diaphragm to hold the lower oesophagus in place as an alternative to traditional surgical fixation of the stomach (i.e., gastropexy) or fundoplication. This GMDN code may reflect old technology.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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