LINXRecalls & reported problems across all models

We found 18 models of LINX by Torax Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,193 adverse event reports in the FDA's MAUDE database, received between Jun 19, 2015 and Aug 11, 2026 — classified as 1,141 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (385 reports).

3 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

LINX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · names 5 of these models · Recall details · FDA record ↗

2. 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-2038-2018 · Root cause: Nonconforming Material/Component · names 6 of these models · Recall details · FDA record ↗

3. 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-2037-2018 · Root cause: Nonconforming Material/Component · names 6 of these models · Recall details · FDA record ↗

Most reported LINX problems

LINX models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LINX LXMC14

  Implant, Anti-Gastroesophageal Reflux
  1 recall289 reports
• LINX LXMC15

  Implant, Anti-Gastroesophageal Reflux
  1 recall261 reports
• LINX LXMC13

  Implant, Anti-Gastroesophageal Reflux
  1 recall169 reports
• LINX LXMC16

  Implant, Anti-Gastroesophageal Reflux
  1 recall167 reports
• LINX LXMC17

  Implant, Anti-Gastroesophageal Reflux
  1 recall145 reports
• LINX LS-[13]

  Implant, Anti-Gastroesophageal Reflux
  1 recall28 reports
• LINX LS-[14]

  Implant, Anti-Gastroesophageal Reflux
  1 recall24 reports
• LINX LXC-[13]

  Implant, Anti-Gastroesophageal Reflux
  1 recall24 reports
• LINX LXC-[14]

  Implant, Anti-Gastroesophageal Reflux
  1 recall18 reports
• LINX LXC-[15]

  Implant, Anti-Gastroesophageal Reflux
  1 recall16 reports
• LINX LXC-[12]

  Implant, Anti-Gastroesophageal Reflux
  1 recall12 reports
• LINX LXC-[16]

  Implant, Anti-Gastroesophageal Reflux
  1 recall11 reports
• LINX LS-[12]

  Implant, Anti-Gastroesophageal Reflux
  1 recall9 reports
• LINX LS-[15]

  Implant, Anti-Gastroesophageal Reflux
  1 recall9 reports
• LINX LS-[16]

  Implant, Anti-Gastroesophageal Reflux
  1 recall6 reports
• LINX LXC-[17]

  Implant, Anti-Gastroesophageal Reflux
  1 recall3 reports
• LINX LS-[17]

  Implant, Anti-Gastroesophageal Reflux
  1 recall1 report
• LINX LSSUS

  Implant, Anti-Gastroesophageal Reflux
  1 report

Recent LINX adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryAug 5, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  It was reported that there was a surgeon who posted a Linx removal procedure today and the sales rep went into procedure and spoke with the surgeon. The surgeon said that the implant was functional and brought reflux relief on the patient for four years and it appeared fully granulated in the tissue and effaced appropriately. However, something happened recently where the patient presented some functional issues with the MSA and the surgeon diagnostically determined that the Linx device was broken. The surgeon showed the sales rep on the back table what had occurred, and the band which holds all of the magnets together were severed, divided or amputated somehow. The sales rep is not sure what forces in the abdomen might cause that but the device was either broken or defective. And upon removal of the device, the surgeon converted the patient to Roux-en-Y Gastric Bypass and procedure went well. The anatomy was very clearly presented after removing the lynx implant.

  Patient problems: Heartburn/Indigestion; Hernia

  MAUDE report 50144332 ↗
• InjuryApr 15, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE LINX EXPLANT WITH DYSPHASIA DIAGNOSIS.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 24888085 ↗
• InjuryMar 26, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS A PATIENT WITH HISTORY OF GERD, HIATAL HERNIA, HYPERTENSION, HYPERLIPIDEMIA, AND OBSTRUCTIVE SLEEP APNEA. MEDICAL RECORDS PROVIDED STATE THAT AFTER FAILING MEDICAL THERAPY, PATIENT UNDERWENT HIATAL HERNIA REPAIR WITH 17B LINX IMPLANTED ON (B)(6) 2019 TO TREAT HIS SYMPTOMS. HE DID WELL FOR ONE YEAR POST IMPLANT WITH THE EXCEPTION ¿OCCASIONAL HEARTBURN AND SOME VOICE CHANGES WITH THROAT SYMPTOMS BUT NO DYSPHAGIA¿ IN LATE 2020 AN ESOPHAGRAM/UPPER GI REVEALED NO REFLUX OR HIATAL HERNIA PRESENT AND LINX IN PLACE. IN LATE SUMMER 2025 SPINAL XRAY INDICATED A DISCONTINUOUS DEVICE. PATIENT REPORTED HE WAS EXPERIENCING MILD GERD SYMPTOMATOLOGY AND UNDERWENT LINX EXPLANT AND HIATAL HERNIA REPAIR ON (B)(6) 2025. POST OPERATIVELY, PATIENT REPORTED INCREASING HEARTBURN AND OCCASIONAL EPIGASTRIC PAIN. MEDICAL THERAPY WAS UNDERTAKEN AND PATIENT IS NOW CONSIDERING FUNDOPLICATION FOR ONGOING REFLUX.

  Patient problems: Heartburn/Indigestion; Hernia; Insufficient Information; Voice alteration

  MAUDE report 24698355 ↗
• InjuryMar 26, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED THAT LINX WAS EXPLANTED. PATIENT WAS HAVING VERY BAD DYSPHASIA, DILATED MULTIPLE TIMES AND STILL WAS HAVING PROBLEMS. NEEDED TO EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 24697931 ↗
• InjuryMar 26, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A LINX IMPLANT OCCURRED ON (B)(6) 2018 EXPLANT (B)(6) 2025 LXMC (B)(6) 2018: PATIENT REPORTS IMPROVEMENT IN SYMPTOMS SINCE THE IMPLANT HOWEVER DOES REPORT SOME INTERMITTENT COUGHING SYMPTOMS. THEY NOTED RECURRENCE OF SYMPTOMS ABOUT A 9 YEAR INTERVAL AFTER HIS PLACEMENT. PT HAD A COUPLE OF ENDOSCOPIES AND THEN SURGEON ASKED PATIENT TO GET SOME IMAGING AND WHICH CONFIRMED A DISRUPTED DEVICE.

  Patient problems: Heartburn/Indigestion; Insufficient Information

  MAUDE report 24697822 ↗
• InjuryMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT HAD A DISRUPTED LINX DEVICE FROM A PREVIOUSLY DONE PROCEDURE. THE PATIENT HAD AN EGD TO CONFIRM THE DISRUPTED LINX.

  Patient problems: Insufficient Information

  MAUDE report 24508251 ↗
• 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 ↗
• InjuryFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A LINX DEVICE IMPLANTED IN 2018 WAS FOUND TO BE BROKEN, AS OBSERVED DURING A C-ARM IMAGING PROCEDURE. THE PATIENT IS SCHEDULED FOR AN EXPLANT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24313014 ↗
• InjuryFeb 4, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED THE LINX DEVICE WAS EXPLANTED DUE TO DYSPHAGIA.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 24257965 ↗
• InjuryJan 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LINX DEVICE WAS DISCONTINUOUS, HAD DILATION AND MRI BUT DONE PER PROTOCOL. THE SURGEON REMOVED LINX PREVIOUSLY IMPLANTED ON (B)(6) 2018.

  Patient problems: Insufficient Information

  MAUDE report 24199354 ↗
• InjuryJan 21, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT LXMC14 WAS EXPLANTED ON (B)(6) 2026 DUE TO PATIENT DISCOMFORT, PAIN, AND DYSPHAGIA. ORIGINALLY IMPLANTED IN 2009. A NISSEN FUNDOPLICATION WAS PERFORMED AFTER REMOVAL OF THE LXMC14. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Discomfort; Dysphagia/ Odynophagia; Pain

  MAUDE report 24130991 ↗
• 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 ↗
• InjuryJan 14, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED VIA JOURNAL ARTICLE : THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YOGESWARAN MUTHUKUMARU , AJIBOLA ADEBISI , MUBARIK REHMAN , DHIREN NEHRA BJS, VOLUME 112, ISSUE SUPPLEMENT_17, DECEMBER 2025 (PUBMED CITATION NOT AVAILABLE) A 37-YEAR-OLD MALE WITH A 5-YEAR HISTORY OF GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) SYMPTOMS¿HEARTBURN AND REGURGITATION¿WAS REFERRED FOR SURGICAL INTERVENTION. HE WAS INTOLERANT OF PROTON PUMP INHIBITORS AND MANAGED WITH CIMETIDINE. LAPAROSCOPY REVEALED A SMALL (3 CM) SLIDING HIATUS HERNIA. KEY STEPS INCLUDED CRURAL DISSECTION, MOBILISATION OF THE OESOPHAGUS, AND PRIMARY HIATUS HERNIA REPAIR USING INTERRUPTED ETHIBOND SUTURES. THE VAGUS NERVE WERE IDENTIFIED AND PRESERVED. A TUNNEL WAS CREATED POSTERIOR TO THE OESOPHAGUS AT THE GOJ, THE OESOPHAGEAL CIRCUMFERENCE WAS MEASURED USING A SIZING TOOL, AND A SIZE 16 LINX DEVICE WAS IMPLANTED. REPORTED COMPLICATIONS INCLUDE PERSISTENT DYSPHAGIA AT 1-YEAR FOLLOW-UP. IN CONCLUSION, THIS CASE HIGHLIGHTS THE UTILITY OF LINX IN SELECTED GORD PATIENTS AND DISCUSSES MANAGEMENT OF PERSISTENT POSTOPERATIVE DYSPHAGIA.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 24066491 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LINX WAS EXPLANTED DUE TO REOCCURRENCE OF UNCONTROLLED HEART BURN AND PATIENT REQUEST FOR EXPLANT. POSITIVE PH STUDIES AND CONVERTED TO FUNDOPLICATION. PATIENT IS DOING WELL.

  Patient problems: Heartburn/Indigestion

  MAUDE report 23988947 ↗