LINX LXMC13Recalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 00855106005332), received between Mar 23, 2016 and Feb 11, 2026 — classified as 164 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (42 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 169 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryOct 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE LINX WAS IMPLANTED ON (B)(6) 2022. THE DEVICE APPEARS TO HAVE ERODED. PRE-AUTHORIZATION FOR REMOVAL IS IN PROGRESS.

  Patient problems: Pocket Erosion

  MAUDE report 23383742 ↗
• InjuryJan 29, 2025Device Appears to Trigger Rejection; Detachment of Device or Device Component; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Detachment of Device or Device Component; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS BROKEN LINX REPORTED. ONLY INFORMATION GIVEN WAS THAT THE LINX DEVICE BROKE AT POST OP.

  Patient problems: Abdominal Distention; Dysphagia/ Odynophagia; Heartburn/Indigestion; Insufficient Information; Pain

  MAUDE report 21263134 ↗
• InjuryDec 4, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE LINX ERODED INTO THE PATIENT¿S ESOPHAGUS. NO EXPLANT DATE GIVEN AT THIS TIME.

  Patient problems: Pocket Erosion

  MAUDE report 20844061 ↗
• InjuryMay 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED DUE TO PERSISTENT DYSPHAGIA. UNKNOWN WHAT STEPS WERE TAKEN PRIOR TO THE DECISION TO EXPLANT. PATIENTS SYMPTOMS HAVE RESOLVED SINCE THE EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19350552 ↗
• InjuryApr 29, 2024Device Appears to Trigger Rejection; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Patient Device Interaction Problem

  IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED DUE TO DYSPHAGIA. IT WAS NOTED BY THE SURGEON THAT THE SIZE MIGHT HAVE BEEN TOO SMALL AND THAT THE PATIENT SHOULD NOT HAVE RECEIVED THE LINX DUE TO THE PATIENT ALREADY EXPERIENCING DYSPHAGIA BUT MAY HAVE HAD SUCCESS IF THE DEVICE WOULD HAVE BEEN LARGER.

  Patient problems: Discomfort; Dysphagia/ Odynophagia

  MAUDE report 19200927 ↗
• InjuryApr 19, 2024Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT A LINX DEVICE WAS NOTED TO BE BROKEN ON RECENT CXR.

  Patient problems: Insufficient Information

  MAUDE report 19142179 ↗
• InjuryMar 6, 2024Device Appears to Trigger Rejection; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT WITH A POSSIBLE DISCONTINUOUS LINX DEVICE. THE DEVICE WAS IMPLANTED ~ 4 YRS AGO, PATIENT HAD DONE WELL UNTIL RECENTLY. SHE WAS COMPLAINING OF DYSPHAGIA AND RECURRENT GERD. UPON X-RAY, A DISCONTINUOUS DEVICE WAS NOTED. THE PATIENT ALSO HAS A SMALL RECURRENT HIATAL HERNIA. SURGEON IS UNSURE THAT HE WILL REMOVE THE DEVICE. IT WILL DEPEND ON THE SEVERITY OF THE PATIENT¿S SYMPTOMS AND HER DESIRE TO HAVE ANOTHER PROCEDURE. HE WILL DISCUSS WITH THE PATIENT.

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

  MAUDE report 18852041 ↗
• InjuryFeb 22, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LINX DEVICE HAS MIGRATED AND ERODED AND IS ON THE STOMACH NOW, THERE IS A SHOULDER ISSUE THAT NEEDS AN MRI.

  Patient problems: Heartburn/Indigestion; Pocket Erosion

  MAUDE report 18761605 ↗
• InjuryFeb 5, 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: 01290-002 EXPERIENCE, DIFFICULTY SWALLOWING: NO PAINFUL SWALLOWING: NO. CONTINUATION OF WORSENING OF GERD SYMPTOMS: YES OTHER TROUBLESOME SYMPTOM THAT MAY BE RELATED TO THE LINX DEVICE AND/OR LINX PROCEDURE: NO. THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 18640236 ↗
• InjuryFeb 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE IS A POSSIBLE DISCONTINUOUS DEVICE. NO DETAILS OTHER THAN THE PATIENT WOULD LIKE THE DEVICE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 18639627 ↗
• InjuryJan 25, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A LINX DEVICE ERODED.

  Patient problems: Pocket Erosion

  MAUDE report 18580918 ↗
• InjuryDec 19, 2023Detachment 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 IS A DISCONTINUOUS LINX DEVICE. DATE OF NEW SYMPTOM ONSET (IF ANY): IN 2021, PATIENT EXPERIENCED RECURRENCE OF REFLUX SYMPTOMS THAT PROMPTED AN XRAY SHOWING DISCONTINUOUS DEVICE. ANY IMAGING POST IMPLANT BUT PRE-DISCOVERY OF DISCONTINUITY: NOT IN OUR MEDICAL RECORDS ANY MRIS SINCE IMPLANT: N/A ANY TRAUMA TO THE AREA POST IMPLANT: N/A GENERAL HEALTH: HEALTHY FEMALE, UNDERWEIGHT ALLERGIES: WHEAT BMI: 18

  Patient problems: Heartburn/Indigestion

  MAUDE report 18356265 ↗
• InjuryDec 1, 2023Device 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 THAT A LINX DEVICE WAS REMOVED DUE TO DYSPHAGIA PROBABLY FROM TOO MUCH SCARRING OVER THE LAST COUPLE OF YEARS. THE DEVICE WAS IMPLANTED IN 2022. VISUALLY EVERYTHING WAS FINE. THERE WAS SIGNIFICANT FUSION BETWEEN THE LIVER AND THE DEVICE.

  Patient problems: Choking; Dysphagia/ Odynophagia; Vomiting

  MAUDE report 18246698 ↗
• InjurySep 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE DURING AN IMPLANT DILATION THE DEVICE BROKE APART DURING THE PROCESS. THERE WILL BE A REMOVAL OF THE DEVICE AND REPLACEMENT (WITHIN 2-6 WEEKS).

  Patient problems: Insufficient Information

  MAUDE report 17834307 ↗
• InjuryAug 25, 2023Device 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 THROUGH J&J MEDICAL DEVICES PER HEALTHCARE PROFESSIONAL: ¿A PATIENT WHO HAD RECEIVED THE LINX DEVICE AS PART OF THE CALIBER STUDY HAS RETURNED TO THE CLINIC WITH IMAGING. IT APPEARS AS THOUGH THE DEVICE HAS DISENGAGED BETWEEN TWO BEADS. UP UNTIL RECENTLY, PATIENT HAS DONE WELL AND MAY IN FACT BE INTERESTED IN RECEIVING A REPLACEMENT DEVICE.

  Patient problems: Dysphagia/ Odynophagia; Insufficient Information; Nausea; Vomiting

  MAUDE report 17623067 ↗
• InjuryAug 16, 2023Detachment 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 THE PATIENT HAD LINX LXMC13 LOG116967 IMPLANTED IN 2016 AT (B)(6). SHE REPORTS SOME RELIEF BUT THEN DEVELOPED REGURGITATION, PAIN, INABILITY TO MOVE, INABILITY TO WORKOUT. IN (B)(6) 2022, PATIENT STATES SHE DEVELOPED ABDOMINAL PAIN AND VOMITING. HAD X RAYS IN (B)(6) 2022 AND THEY FOUND OUT THAT THE DEVICE WAS LOOSE. SHE HAD IT REMOVED AND A NEW ONE IMPLANTED IN (B)(6) 22.

  Patient problems: Heartburn/Indigestion; Hernia; Inflammation; Nausea; Pain; Vomiting

  MAUDE report 17558608 ↗
• InjuryJun 29, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE LXMC13 HAD CAUSED AN EROSION INTO THE STOMACH. IT WAS REMOVED (B)(6) 2023.

  Patient problems: Pocket Erosion

  MAUDE report 17224528 ↗
• InjuryJun 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT DR. (B)(6) SAW A PATIENT WHO HAD A LINX IMPLANTED YEARS AGO AND IS HAVING VERY BAD DYSPHASIA AND NEEDS TO HAVE THE LINKS REMOVED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 17198018 ↗
• InjuryJun 21, 2023Device 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 THAT A LINX EXPLANT HAS BEEN SCHEDULED FOR (B)(6) 2023. PATIENT WAS EXPERIENCING CHEST PAINS AND SEVERE DYSPHAGIA. DOCTOR HAS PREFORMED THREE DILATIONS PRIOR TO SCHEDULING THE EXPLANT.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 17174366 ↗
• InjuryJun 7, 2023Device Appears to Trigger Rejection; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Patient Device Interaction Problem

  IT WAS REPORTED THAT A LINX WAS REMOVED DUE TO CHRONIC DYSPHASIA.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 17078218 ↗
• InjuryMay 2, 2023Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT TRX_2018_01: 01166-014 EVENT: DYSPHAGIA. RELATIONSHIP TO STUDY DEVICE: POSSIBLE RELATIONSHIP. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE RELATIONSHIP.

  Patient problems: Anxiety; Dysphagia/ Odynophagia; Heartburn/Indigestion; Vomiting

  MAUDE report 16852961 ↗
• InjuryApr 26, 2023Detachment 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 POST-OP TO THE LINX PROCEDURE THAT THE DEVICE IS DISCONNECTED AND CAN BE SEEN THROUGH THE X-RAY. AN MRI IS BEING COMPLETED. PATIENT IS IN A LOT OF PAIN AND WANTS THE DEVICE TAKEN OUT IMMEDIATELY.

  Patient problems: Abdominal Distention; Heartburn/Indigestion; Pain; Vomiting

  MAUDE report 16815039 ↗
• InjuryApr 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THIS PATIENT HAS TERRIBLE DYSPHAGIA SINCE THE IMPLANT PROCEDURE IN 2021 AND FAILED MULTIPLE DILATIONS AND STATED THAT THEY ARE PRETTY SICK OVER ALL. THEY ARE RUNNING TEST AND PLANNING THE EXPLANT SOME TIME THIS SUMMER.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 16743559 ↗

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-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
• 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