LINX LXC-[12]Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00855106005134), received between Jan 5, 2016 and Mar 9, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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-2038-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LINX DEVICE WAS IMPLANTED IN 2011 AND HAS BEEN REMOVED/EXPLANTED.

  Patient problems: Insufficient Information; Pain; Pocket Erosion

  MAUDE report 16512163 ↗
• InjuryJun 29, 2022Migration or Expulsion of Device; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A LINX DEVICE EROSION WITH PLANNED EXPLANT. PATIENT LOST 50 LBS. EXPLANT MAY TAKE PLACE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Chest Pain; Dysphagia/ Odynophagia; Pocket Erosion; Weight Changes

  MAUDE report 14854885 ↗
• InjuryOct 12, 2020Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN EDG ON (B)(6) 2020, IT WAS FOUND THAT 3 BEADS OF THE LINX DEVICE WERE PARTIALLY ERODED. THE PATIENT RETURNED ON (B)(6) 2020 FOR EXPLANT. EXPLANT WAS SUCCESSFUL.

  Patient problems: Dysphagia/ Odynophagia; Erosion; No Code Available

  MAUDE report 10662542 ↗
• InjuryMar 19, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DOCTOR HAD EXPLANTED A 12-BEAD LINX DEVICE FROM A PATIENT DUE TO SUDDEN RE-OCCURRENCE OF GERD. DOCTOR BELIEVED THE DEVICE HAD COME APART BEFORE THE REMOVAL CASE. DOCTOR DID NOT PLACE ANOTHER DEVICE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. PATIENT IS NOT PART OF A CLINICAL STUDY.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion; Hernia; No Code Available; Vomiting

  MAUDE report 9856532 ↗
• InjuryMay 16, 2019Material Erosion; Malposition of Device

  IT WAS REPORTED, LINX REMOVED DUE TO EROSION. THE PATIENT DID NOT HAVE AN AUTOIMMUNE DISEASE. MEDICATION TAKEN, LANSOPRAZOLE 2 WEEKS. THE IMPLANT DATE IS UNKNOWN. THERE WERE NO INTRA-OP COMPLICATIONS. THERE WAS NO HIATAL HERNIA/CRURAL DONE AT THE TIME OF IMPLANT. THE DEVICE WAS NOT FOUND AT THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL (EROSION). A NEW LINX WAS NOT PLACE AFTER THE INITIAL LINX WAS REMOVED. THEE BEADS ERODED. THE PATIENT STAYED 2 DAYS AND THEN WAS DISCHARGED.

  Patient problems: No Code Available; Pocket Erosion

  MAUDE report 8617275 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR IMPLANTED THE LINX DEVICE IN THE PATIENT FIVE YEARS AGO. THE PATIENT REPORTED PERSISTENT DYSPHAGIA AND THE PATIENT HAD AN EXPLANT ON (B)(6) 2018, WHERE THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. NO OBSERVATIONS OR INTERVENTIONS WERE NOTED. IT ISN'T KNOWN IF THE PATIENT SYMPTOMS HAVE PERSISTED.

  Patient problems: No Code Available; Pain

  MAUDE report 7947115 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA AND ONGOING GERD LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE INCLUDING LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE IN (B)(6) 2014. DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2018. A FUNDOPLICATION WAS PERFORMED IMMEDIATELY AFTER DEVICE EXPLANT. DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY. IT WAS NOTED THAT THERE WAS A "DENSE CAPSULE AND SCAR TISSUE IN THE REGION OF THE LINX AND SURROUNDING IT."

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 7802589 ↗
• InjuryFeb 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED CHEST PAIN LEADING TO ENDOSCOPIC VISUALIZATION OF 1-2 DEVICE BEADS ERODED INTO THE ESOPHAGEAL LUMEN AND SUBSEQUENT ENDOSCOPIC EXPLANT OF THE ERODED LINX DEVICE BEADS. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2014. PATIENT PRESENTED WITH CHEST PAIN (B)(6) 2017. ONE TO TWO DEVICE BEADS WERE OBSERVED ENDOSCOPICALLY ON (B)(6) 2017 IN THE POSTERIOR SIDE OF THE ESOPHAGEAL LUMEN. THREE BEADS OF THE LINX DEVICE WERE REMOVED ENDOSCOPICALLY WITH A LOOP-CUTTER ON (B)(6) 2017; PATIENT WAS REPORTED AS DOING WELL AFTER THE PROCEDURE. A LAPAROSCOPIC PROCEDURE TO REMOVE THE REMAINING NINE BEADS OCCURRED ON (B)(6) 2017; NO BEADS WERE PRESENT AS CONFIRMED BY A CHEST X-RAY. "THE ONLY THOUGHT IS IT MIGRATED INTO THE LUMEN AND SHE PASSED IT." THE PATIENT HAD A PARTIAL FUNDOPLICATION ON (B)(6) 2017 AND WAS REPORTED AS DOING WELL.

  Patient problems: Chest Pain; Erosion

  MAUDE report 6307487 ↗
• InjurySep 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. A TOTAL OF 9 OF 12 LINX BEADS WERE EXPLANTED ON (B)(6) 2016. THREE REMAINING BEADS WERE SEPARATED FROM DEVICE DURING EXPLANT. PHYSICIAN DOES NOT PLAN TO REMOVE THE REMAINING 3 BEADS. PATIENT REPORTED AS DOING WELL AFTER EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5970843 ↗
• InjuryApr 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ONGOING GERD LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2014. UNEVENTFUL DEVICE EXPLANT (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. HIATAL HERNIA (4-5CM) DEVELOPED BETWEEN THE TIME OF IMPLANT AND EXPLANT. AFTER DEVICE REMOVAL, PATIENT UNDERWENT NISSEN FUNDOPLICATION.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5606398 ↗
• InjuryFeb 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2014. GASTROESOPHAGEAL BALLOON DILATION ATTEMPTED IN (B)(6) 2015 TO ADDRESS POST-PROCEDURAL MODERATE DYSPHAGIA DID NOT ALLEVIATE SYMPTOMS. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2016. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5440785 ↗
• InjuryJan 5, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION REPORTED AS (B)(6) 2014. ENDOSCOPY COMPLETED (B)(6) 2015 DUE TO DYSPHAGIA REVEALED A BEAD (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. ENDOSCOPIC REMOVAL OF ENTIRE LINX DEVICE WAS CONDUCTED ON (B)(6) 2015. PATIENT CONDITION REPORTED AS WELL FOLLOWING THE EXPLANT PROCEDURE.

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 5345277 ↗

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-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-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-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-2039-2018 · Apr 20, 2018 · Terminated
  LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Produc