LINX LXMC15Recalls & reported problems
Torax Medical, Inc. · LINX Reflux Management System · Class 3 · Implant
Quick summary
This LINX reflux management system has 261 adverse event reports, including 250 injuries, 11 malfunctions and no deaths. Reports mostly describe difficulty swallowing and heartburn, many describing removal of the device, and some describe the body appearing to reject the device or the device coming apart. There is 1 closed recall naming this device, started in April 2018, over a possible bead component separating from a wire link.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 261
- Deaths reported
- 0
- Injuries reported
- 250
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 261 adverse event reports that list this exact device (DI 00855106005356), received between Feb 8, 2016 and Aug 11, 2026 — classified as 250 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (115 reports).
1 FDA recall record name this device's identifier.
4 other recalls cover devices cleared under the same FDA submission (P100049); they may or may not involve this specific model.
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
Recalls naming this device
- Apr 20, 2018Terminated
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Z-2039-2018 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem119
- Device Appears to Trigger Rejection115
- Patient Device Interaction Problem52
- Detachment of Device or Device Component25
- Appropriate Device Problem Term/Code Not Available13
- Migration or Expulsion of Device12
- Therapeutic or Diagnostic Output Failure7
- Insufficient Device Problem Information5
Patient problems
- Dysphagia/ Odynophagia173
- No Code Available77
- Heartburn/Indigestion55
- Insufficient Information25
- Vomiting24
- Pain17
- Hernia11
- Nausea11
Recent adverse event reports
The 25 most recent of 261 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
It was reported that during a LINX removal procedure, the sales representative entered the operating room and observed the surgeon dissecting the LINX device from the stomach. Following the procedure, the sales rep. inquired whether the patient's condition would be revised to perform a gastric bypass; however, the surgeon indicated that the patient had already undergone a gastric bypass procedure. It was reported that the patient had experienced severe dysphagia associated with the LINX implant, which also resulted in emotional distress. Additionally, the patient reportedly had a history of severe dysphagia prior to the initial LINX implantation, which had been performed several years earlier. The device was removed during the procedure.
Patient problems: Distress; Dysphagia/ Odynophagia; Heartburn/Indigestion
MAUDE report 50208913 ↗InjuryApr 15, 2026Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE LINX EXPLANT WITH DYSPHASIA DIAGNOSIS.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 24888085 ↗MalfunctionFeb 11, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A LINX DEVICE, THE PACKAGING WAS FOUND TO BE TAMPERED WITH AND HAD A VISIBLE TEAR. THE SURGICAL TEAM DECIDED NOT TO USE THE DEVICE DUE TO COMPROMISED STERILITY. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313110 ↗InjuryJan 21, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT AN LXMC15 IMPLANTED IN (B)(6) 2025 WAS REMOVED FOLLOWING UNSUCCESSFUL PATIENT RELIEF AFTER DILATION. A ROBOTIC NISSEN FUNDOPLICATION WAS PERFORMED FOLLOWING REMOVAL OF THE LINX DEVICE.
Patient problems: Insufficient Information
MAUDE report 24130798 ↗InjuryNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT HAD A LINX PLACED AND SURGEON IS DOING THE REMOVAL.
Patient problems: Insufficient Information
MAUDE report 23485896 ↗InjuryMar 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE LINX WAS REMOVED ROBOTICALLY. PATIENT HAD THE DEVICE REMOVED DUE TO DYSPHAGIA. NO PLANS FOR ANOTHER DEVICE.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 21641875 ↗InjuryJan 15, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ABOUT A YEAR AGO THE PATIENTS SYMPTOMS STARTING COMING BACK. IMAGING WAS DONE RECENTLY WHICH FOUND THE DEVICE TO BE DISCONTINUOUS. EXPLANT HAS NOT YET BEEN SCHEDULED.
Patient problems: Heartburn/Indigestion; Insufficient Information
MAUDE report 21158195 ↗InjuryDec 9, 2024Device Appears to Trigger Rejection; Detachment of Device or Device Component; Device Appears to Trigger Rejection; Detachment of Device or Device Component
IT WAS REPORTED THAT A LINX WAS DISCONTINUOUS. THE CLASP WAS STILL INTACT. DISCONTINUOUS DEVICE WAS FOUND DURING X-RAY. PATIENT WAS EXPERIENCING DYSPHAGIA. PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. ANOTHER DEVICE WAS NOT IMPLANTED. SURGEON DID A PARTIAL FUNDOPLICATION.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 20877604 ↗InjuryNov 20, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE SURGEON WAS DOING A LIAISON OF ADHESION BUT WHILE DOING SO THEY NOTICED THAT THE LINX DEVICE WAS SLIDING TOO FREELY IN THE TRACT THAN IT USUALLY SHOULD APPEARING TO BE COLONIZED. SURGEON REMOVED IT AND SENT IT TO PATHOLOGY FOR REVIEW.
Patient problems: Insufficient Information
MAUDE report 20733138 ↗InjuryNov 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT PATIENT ASKED TO HAVE LINX REMOVED DUE TO DYSPHAGIA. SURGEON STATED THAT THE LINX WAS PERFORMING APPROPRIATELY AND ADDRESSING THE PATIENTS GERD ISSUE.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 20706921 ↗InjuryOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PER USER FACILITY MEDWATCH FORM, #MW5159791 DURING AN UNKNOWN PROCEDURE; THE LINX DEVICE DISRUPTED.
Patient problems: Insufficient Information
MAUDE report 20556222 ↗InjuryAug 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A LINX WAS REMOVE PER THE PATIENTS REQUEST. PER THE DOCTOR, NO MEDICAL REASONING BEHIND THE REMOVAL, THE PATIENT SAID HE WANTS TO BE ABLE TO EAT WHATEVER HE WANTS. CASE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 19980776 ↗InjuryAug 13, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LINX DEVICE WAS DISCONTINUED. THE PATIENT WILL BE HAVING THE DEVICE EXPLANTED AND OPTING FOR A FUNDOPLICATION VERSE A NEW LINX DEVICE.
Patient problems: Heartburn/Indigestion; Insufficient Information
MAUDE report 19971467 ↗InjuryAug 13, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS DISCONTINUOUS BAND AND RETURN OF REFLUX SYMPTOMS.
Patient problems: Heartburn/Indigestion
MAUDE report 19971072 ↗InjuryJul 22, 2024Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA CLINICAL TRIAL PATIENT TRX_2018_01: 01443-011 EXPERIENCE, ESOPHAGEAL SPASMS, DEVICE EXPLANT. RELATIONSHIP TO STUDY DEVICE: BLANK.
Patient problems: Cramp(s) /Muscle Spasm(s); Dysphagia/ Odynophagia
MAUDE report 19791956 ↗InjuryJul 1, 2024Device Appears to Trigger Rejection; Detachment of Device or Device Component; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Detachment of Device or Device Component; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT HAS A POSSIBLE DISRUPTED LINX. IT WAS PLACED BY SURGEON (B))(6) 2021. IT WAS SCHEDULED TO BE EXPLANTED (B)(6) 2024. PATIENT PRESENTED IN MAY WITH A FEW MONTHS HISTORY OF REOCCURRING COUGH AND ON EGD LINX WAS DISRUPTED. PATIENT HAS UNDERGONE THREE RFA'S FOR BARRETT'S POST PLACEMENT THE LAST TREATMENT WAS (B)(6) 2022.
Patient problems: Dysphagia/ Odynophagia; Insufficient Information
MAUDE report 19643991 ↗InjuryJul 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT A LINX WAS REMOVED DUE TO DYSPHAGIA. THE DEVICE WAS IMPLANTED ON (B)(6) 2019. PATIENT IS RECOVERING WELL, AND THEY TRIED THREE DILATIONS WITHIN THE PAST YEAR TO HELP.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 19643331 ↗InjuryJun 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, DYSPHAGIA. RELATIONSHIP TO STUDY DEVICE: BLANK.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 19604881 ↗InjuryMay 21, 2024Device Appears to Trigger Rejection; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Patient Device Interaction Problem
IT WAS REPORTED THAT THE LXMC15 HAD ISSUES DURING AN UNKNOWN CASE.
Patient problems: Dysphagia/ Odynophagia; Inflammation; Swelling/ Edema
MAUDE report 19359280 ↗InjuryMay 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED. NO ADDITIONAL INFORMATION GIVEN.
Patient problems: Insufficient Information
MAUDE report 19277134 ↗InjuryApr 25, 2024Device Appears to Trigger Rejection; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A BROKEN LINX DISCOVERED DURING SURGERY. REASON FOR REMOVAL, DYSPHAGIA. EGD (B)(6) 2023- LOSE NISSEN, BILE REFLUX, DEVICE FOUND TO BE BROKEN DURING SURGERY ON (B)(6) 2024. THE PATIENT DID NOT GO UNDER ANY MRI. THE PATIENT DID NOT RECEIVE A REPLACEMENT.
Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion
MAUDE report 19180805 ↗InjuryApr 22, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
InjuryApr 10, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT A LINX WAS EXPLANTED DUE TO DYSPHAGIA. PRIOR TO EXPLANT THE PATIENT RECEIVED A COUPLE DILATIONS BUT THE PATIENT WAS STILL SYMPTOMATIC.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 19079337 ↗InjuryFeb 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, DYSPHAGIA, RELATIONSHIP TO STUDY DEVICE: POSSIBLE. (B)(6).
Patient problems: Dysphagia/ Odynophagia
MAUDE report 18725518 ↗InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS RECURRENT REFLUX. POSTSURGICAL CHANGES WITHOUT RESIDUAL OR RECURRENT HERNIA PH BRAVO- PATIENT SPENT 10.7% OF TIME IN REFLUX WITH 110 ACID REFLUX EPISODES AND COMPOSITE DEMEESTER SCORE 32.7. TESTING DID NOT REVEAL DISCONTINUED LINX DEVICE. THE PATIENT DID NOT UNDERGO ANY MRI.
Patient problems: Heartburn/Indigestion
MAUDE report 18697497 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P100049. One submission often covers many models, so check the product and lot details in each record.
- Z-2040-2018 · Apr 20, 2018 · TerminatedLINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code
- Z-2037-2018 · Apr 20, 2018 · TerminatedLINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Cod
- Z-2041-2018 · Apr 20, 2018 · TerminatedLINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product C
- Z-2038-2018 · Apr 20, 2018 · TerminatedLINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product C
Other Implant, Anti-Gastroesophageal Reflux devices
- LINX LXMC14Torax Medical, Inc. · Implant, Anti-Gastroesophageal Reflux1 recall289 reports
- LINX LXMC13Torax Medical, Inc. · Implant, Anti-Gastroesophageal Reflux1 recall169 reports
- LINX LXMC16Torax Medical, Inc. · Implant, Anti-Gastroesophageal Reflux1 recall167 reports
- LINX LXMC17Torax Medical, Inc. · Implant, Anti-Gastroesophageal Reflux1 recall145 reports
- LINX LS-[13]Torax Medical, Inc. · Implant, Anti-Gastroesophageal Reflux1 recall28 reports
- LINX LXC-[13]Torax Medical, Inc. · Implant, Anti-Gastroesophageal Reflux1 recall24 reports
- LINX LS-[14]Torax Medical, Inc. · Implant, Anti-Gastroesophageal Reflux1 recall24 reports
- LINX LXC-[14]Torax Medical, Inc. · Implant, Anti-Gastroesophageal Reflux1 recall18 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.