LINX LXMC14Recalls & reported problems

Summary

The FDA's MAUDE database contains 289 adverse event reports that list this exact device (DI 00855106005349), received between Nov 4, 2015 and Mar 26, 2026 — classified as 273 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (104 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.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 289 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• InjuryOct 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE LINX DEVICE WAS EXPLANTED BECAUSE THE PATIENT WAS CONVERTED TO A FUNDOPLICATION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23413021 ↗
• InjuryFeb 3, 2025Device 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 PATIENT PRESENTED WITH BROKEN LINX IMPLANT WHILE UNDER MRI. THE CURRENT SURGEON DID NOT PLACE THESE DEVICES. THE SURGEON WHO PLACED THEM ARE NOW AT A DIFFERENT FACILITY.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion; Insufficient Information

  MAUDE report 21291130 ↗
• InjuryDec 6, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT HAS A DISCONTINUOUS LINX DEVICE AND THE BEAD SEPARATED FROM ONE OF THE ATTACHMENTS. AT THE TIME OF THE CALL IT WAS UNKNOWN IF AN EXPLANT WOULD OCCUR. PATIENT CAME BACK DUE TO REFLUX. A CHEST X-RAY CONFIRMED THAT THE LINX WAS DISCONTINUOUS.

  Patient problems: Heartburn/Indigestion; Pneumonia

  MAUDE report 20866253 ↗
• InjuryNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A LINX IS DISRUPTED.

  Patient problems: Insufficient Information

  MAUDE report 20683722 ↗
• InjuryNov 12, 2024Migration or Expulsion of Device; Device Appears to Trigger Rejection; Patient Device Interaction Problem; Migration or Expulsion of Device; Device Appears to Trigger Rejection; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PROCEDURE IS SET TO TAKE PLACE IN A FEW WEEKS AND DURING PRE-EVALUATION THE PATIENT HAD THE LINX ERODE TO THEIR ESOPHAGUS. THEY ARE GOING TO REMOVE THE BEAD AND EVENTUALLY REMOVE THE ENTIRE LINX IN A SEPARATE PROCEDURE.

  Patient problems: Dysphagia/ Odynophagia; Pocket Erosion; Ulcer

  MAUDE report 20665155 ↗
• InjuryOct 22, 2024Device Appears to Trigger Rejection; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Patient Device Interaction Problem

  IT WAS REPORTED THAT A LINX HAD TO BE REMOVED DUE TO COMPLICATIONS.

  Patient problems: Dysphagia/ Odynophagia; Insufficient Information

  MAUDE report 20504245 ↗
• InjuryOct 15, 2024Migration or Expulsion of Device; Device Appears to Trigger Rejection; Migration or Expulsion of Device; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED DUE TO DYSPHAGIA AND PARTIAL EROSION INTO THE ESOPHAGUS. PROCEDURE WAS SUCCESSFUL IN REMOVING THE DEVICE. PATIENT CURRENTLY DOING GOOD.

  Patient problems: Dysphagia/ Odynophagia; Pocket Erosion

  MAUDE report 20450665 ↗
• InjurySep 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT IS CONSIDERING REMOVAL WITH OR WITHOUT FUNDOPLICATION DUE TO RECENT WORK UP SHOWING A BROKEN LINX. NO FURTHER INFORMATION WAS PROVIDED TO THE SALES REP.

  Patient problems: Insufficient Information

  MAUDE report 20259201 ↗
• InjurySep 12, 2024Migration or Expulsion of Device; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS THAT A PATIENT HAD THE LINX REMOVED. THE LINX DEVICE, LXMC14, WAS IMPLANTED ON (B)(6) 2023. THE PATIENT WAS HAVING DYSPHAGIA AND REFLUX DUE TO A SMALL AMOUNT OF MIGRATION OF THE STOMACH THRU THE DEVICE. THEY DID CONFIRM THAT THERE WAS NOTHING WRONG WITH THE DEVICE. THE PATIENT WAS OVERALL HAPPY AND THAT THE REFLUX GOT BETTER, IT SIGNIFICANTLY IMPROVED. BUT DECIDED TO REMOVE IT DUE TO THE MIGRATION.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion; Hernia

  MAUDE report 20199371 ↗
• InjuryAug 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A LINX DEVICE WILL BE EXPLANTED TODAY (B)(6) 2024 DUE TO DYSPHAGIA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19971278 ↗
• InjuryJul 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THERE WAS A LINX REMOVAL BECAUSE THE PATIENT WAS DEALING WITH DYSPHAGIA. IT WAS IMPLANTED A YEAR AGO AND WAS EXPLANTED (B)(6) 2024. SURGEON STATED THAT IT COULD'VE BEEN CAUSED DUE TO THE LINX BEING TOO SMALL FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS GIVEN TO THE REP.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19782849 ↗
• InjuryJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FACILITY HAS A PATIENT WHO'S LINX HAS BROKEN WHICH WAS CONFIRMED BY X-RAY. DEVICE HAS NOT BEEN EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED TO THE SALES REP AT THE TIME OF REPORTING.

  Patient problems: Insufficient Information

  MAUDE report 19740157 ↗
• InjuryJun 13, 2024Migration or Expulsion of Device; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS AN EXPLANT OF LINX DUE TO EROSION OF THE ESOPHAGUS. DEVICE WAS IMPLANTED IN 2018.

  Patient problems: Diarrhea; Dysphagia/ Odynophagia; Heartburn/Indigestion; Paresis; Pocket Erosion; Vomiting

  MAUDE report 19529092 ↗
• InjuryMay 16, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LINX DEVICE WAS FOUND TO BE DISCONTINUOUS. THE PATIENT HAD AN MRI ON (B)(6) 2024 AFTER WHICH SHE EXPERIENCED PAIN AND DISCOMFORT IN HER UPPER GASTRIC AREA AND HER REFLUX RETURNED. AN X-RAY WAS DONE TO TAKE A LOOK AT THE DEVICE WHICH WAS FOUND TO BE DISCONTINUOUS.

  Patient problems: Heartburn/Indigestion; Pain

  MAUDE report 19331562 ↗
• InjuryMay 14, 2024Device Appears to Trigger Rejection; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Patient Device Interaction Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, DYSPHAGIA AND "FULLNESS" IN THROAT. RELATIONSHIP TO STUDY DEVICE: POSSIBLE.

  Patient problems: Dysphagia/ Odynophagia; Insufficient Information

  MAUDE report 19308992 ↗
• InjuryApr 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A LINX WAS EXPLANTED DUE TO DYSPHAGIA. LINX WAS IMPLANTED (B)(6) 2017 AT BAYLOR SCOTT AND WHITE, DYSPHAGIA BEGAN (B)(6) 2024, EXPLANTED ON (B)(6) 2024.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19151819 ↗
• InjuryApr 10, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT HAD A LINX PLACED BY ANOTHER SURGEON IN THE (B)(6) AREA IN (B)(6) OF 2017. SHE HAD SILENT REFLUX BUT HAD A HH REPAIR WITH LINX FOR HER SEVERE LPR SYMPTOMS. THESE SYMPTOMS HAVE RECURRED OVER THE PAST 6 MONTHS OR SO. ON AN X-RAY FOR HER BACK PROBLEMS, IT WAS DISCOVERED THAT HER LINX IS BROKEN.

  Patient problems: Heartburn/Indigestion; Hernia

  MAUDE report 19078887 ↗
• InjuryApr 5, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT HAD A SIZE 14 LINX IMPLANTED FOR TREATMENT OF GERD IN 2018 AT AN UNKNOWN FACILITY IN NORTH CAROLINA. PATIENT BEGAN RECENTLY TREATING WITH ANOTHER PHYSICIAN FOR RETURN OF SYMPTOMS AND DEVICE WAS FOUND TO BE DISCONTINUOUS. PATIENT IS IN THE PROCESS OF SCHEDULING REMOVAL OF THE LINX DEVICE AND COUNSEL FOR PATIENT WILL ALLOW DEVICE ANALYSIS AND PROVIDE NECESSARY INFORMATION.

  Patient problems: Heartburn/Indigestion; Hernia

  MAUDE report 19049458 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED FOR UNKNOWN REASONS. PATIENT CURRENT STATUS WAS NOT PROVIDED TO THE SALES REP.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 18987220 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LINX WAS EXPLANTED. NO INFORMATION FOR THE REASON GIVEN.

  Patient problems: Cramp(s) /Muscle Spasm(s); Insufficient Information

  MAUDE report 18852091 ↗
• InjuryMar 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON REMOVED A LINX DEVICE FROM A PATIENT THAT HAD BEEN IMPLANTED SINCE 2018 DUE TO INEFFECTIVENESS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18851922 ↗
• InjuryFeb 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A PATIENT WITH POSSIBLE DISCONTINUOUS DEVICE. LITTLE DETAIL AT THIS TIME BUT PLAN IS TO REMOVAL AND DO PARTIAL FUNDOPLICATION.

  Patient problems: Insufficient Information

  MAUDE report 18761507 ↗

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-2037-2018 · Apr 20, 2018 · Terminated
  LINX 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-2038-2018 · Apr 20, 2018 · Terminated
  LINX 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
• Z-2040-2018 · Apr 20, 2018 · Terminated
  LINX 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-2041-2018 · Apr 20, 2018 · Terminated
  LINX 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