LINX LXMC17Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 00855106005370), received between Oct 7, 2016 and Aug 5, 2026 — classified as 139 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (52 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryNov 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A LINX EXPLANT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH ESOPHAGEAL CANCER AND REQUIRES RADIATION TREATMENT; THEREFORE, THE DEVICE NEEDED TO BE EXPLANTED.

  Patient problems: Cancer

  MAUDE report 23597014 ↗
• InjuryMar 19, 2025Device 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, PATIENT HAD DIFFICULTY SWALLOWING. DISCOMFORT AND DIFFICULTY SWALLOWING. THE REMOVAL IS THE PATIENT'S SOLUTION FOR NOW. THE SURGEON DID SAY THE PATIENT'S ESOPHAGEAL FUNCTIONALITY WAS NOT AS HEALTHY AS INITIALLY THOUGHT.

  Patient problems: Discomfort; Dysphagia/ Odynophagia

  MAUDE report 21641856 ↗
• InjuryDec 9, 2024Device 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 THAT A LINX DEVICE WAS EXPLANTED DUE TO DYSPHAGIA AND DISCOMFORT. NO FURTHER INFORMATION WAS PROVIDED TO THE SALES REP.

  Patient problems: Chest Pain; Discomfort; Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 20877722 ↗
• MalfunctionDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LINX DEVICE IMPLANTED ON (B)(6) 2024 AND NOW THE PATIENT IS EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 20817973 ↗
• InjuryOct 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS REMOVAL OF LINX DEVICE. REASON FOR REMOVAL WAS THE STOMACH HERNIATED THROUGH THE LINX DEVICE.

  Patient problems: Hernia

  MAUDE report 20460538 ↗
• InjuryJul 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT BETWEEN THE IMPLANT AND THE EXPLANT OF THE LINX DEVICE THE PATIENT HAD TWO DILATIONS PRIOR TO REMOVAL. PATIENT IS DOING FINE AFTER EXPLANT. THE PATIENT HAD THE DEVICE REMOVED DUE TO DYSPHAGIA.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19771747 ↗
• InjuryJun 10, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE LINX WAS EXPLANTED DUE TO DYSPHAGIA. THE PATIENT'S IMPLANT WAS DONE IN 2019 AND HAD NO ISSUES FOR 5 YEARS. LINX WAS EXPLANTED ON (B)(6) 2024. PATIENT IS RECOVERING WELL WITH NO FURTHER ISSUES.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19499859 ↗
• InjuryJun 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD CHRONIC ISSUES (UNSPECIFIED) AND REQUESTED EXPLANT. PATIENT CAME FROM A DIFFERENT IMPLANTING SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 19497693 ↗
• InjuryMay 13, 2024Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THE SURGEON EXPLANTED A LINX FROM A PATIENT.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Dysphagia/ Odynophagia; Insufficient Information; Vomiting; Weight Changes

  MAUDE report 19297290 ↗
• InjuryMay 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LINX WAS EXPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19277080 ↗
• InjuryApr 25, 2024Device 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 THAT A LINX HAD TO BE EXPLANTED DUE TO PERSISTENT NAUSEA, VOMITING AND UNINTENTIONAL WEIGHT LOSS.

  Patient problems: Dysphagia/ Odynophagia; Hernia; Nausea; Vomiting; Weight Changes

  MAUDE report 19180706 ↗
• InjuryApr 18, 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.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19137864 ↗
• InjuryApr 18, 2024Device Appears to Trigger Rejection; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LINX WAS REMOVED ON (B)(6) 2024. THERE WAS NOTHING WRONG WITH THE LINX AND THE PATIENT. THE REASON FOR REMOVAL WAS BECAUSE WHEN THEY OPERATED, THE ESOPHAGUS WAS ATTACHED TO CHEST OF THE PATIENT AND THEY WERE TRYING TO MOBILIZE BUT COULDN'T WHICH MADE THEM REMOVE IT. THEY WERE WORRIED THE PATIENT WAS GOING TO SUFFER A STROKE FROM BEING UNDER THE ANESTHESIA FOR TOO LONG AND THE PLAN WAS ORIGINALLY PRESERVE THE LINX BUT WAS FORCED TO THIS SCENARIO DUE TO HER ANATOMY.

  Patient problems: Dysphagia/ Odynophagia; Insufficient Information; Pain

  MAUDE report 19137854 ↗
• InjuryMar 1, 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 PATIENT HAD A (B)(6) EXPLANTED. ORIGINALLY IMPLANTED 12-14 MONTHS AGO. THE LINX WAS EXPLANTED DUE TO DYSPHASIA AND AFTER A CT SCAN THE LINX LOOKED TO BE OUT OF PLACE.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18817003 ↗
• InjuryJan 3, 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 A LINX DEVICE WAS EXPLANTED DUE TO THE DEVICE BEING DISCONTINUOUS. NO KNOWN DRUG ALLERGIES, HX- BARRETTS, HTN, RA. A NEW SIZE 17 DEVICE WAS IMPLANTED.

  Patient problems: Heartburn/Indigestion; Insufficient Information; Vomiting

  MAUDE report 18435637 ↗
• InjuryJan 2, 2024Device 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 THAT A LINX DEVICE WAS IMPLANTED ON (B)(6) 2019 AND EXPLANTED ON (B)(6) 2023 THE PATIENT ORIGINALLY HAD A HISTORY OF A SLEEVE GASTRECTOMY. AFTER HER SLEEVE GASTRECTOMY SHE DEVELOPED WORSENING ISSUES WITH GERD AT THE TIME DID NOT WANT TO CONSIDER REVISION TO ROUX EN Y GASTRIC BYPASS TO MANAGE HER GERD. SHE OPTED TO UNDERGO LINX PLACEMENT. FOLLOWING LINX PLACEMENT ON (B)(6) 2019 THE PATIENT HAD SIGNIFICANT IMPROVEMENT IN HER GERD SYMPTOMS. AROUND (B)(6) 2022 PATIENT FIRST COMPLAINED OF SOME SYMPTOMS OF FOOD GETTING STUCK AND SOME ISSUES WITH REGURGITATION. SHE UNDERWENT AN EGD AND BALLOON DILATION ACROSS THE LINX ON (B)(6) 2022 WHICH TEMPORARILY RESOLVED HER SYMPTOMS. AROUND (B)(6) 2023 PATIENT AGAIN PRESENTED WITH WORSENING GERD SYMPTOMS. BARIUM UPPER GI WAS PERFORMED WHICH SHOWED LINX IN GOOD POSITION, BUT PATIENT WAS DEVELOPING SOME ESOPHAGEAL DILATION. STEROIDS WERE PRESCRIBED WITH MINIMAL IMPROVEMENT. PATIENT CONTINUED TO TRY AND DO DIETARY MODIFICATION BUT SYMPTOMS WORSENED. SHE HAD REGAINED A SIGNIFICANT AMOUNT OF WEIGHT DUE TO IMMOBILITIY ISSUES, AND HER DIABETES WAS WORSENING. ANOTHER EGD WAS DONE ON (B)(6) 2023 WHICH SHOWED THE PATIENT HAD NOW DEVELOPED SIGN

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

  MAUDE report 18426100 ↗
• InjuryDec 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) EXPERIENCE, DYSPHAGIA. RELATIONSHIP TO STUDY DEVICE: NO.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18356570 ↗
• InjuryDec 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DISCONTINUOUS LINX DEVICE WAS FOUND. DATE OF SYMPTOM ONSET: (B)(6) 2023 GENERAL HEALTH: GOOD BMI: 34.7 ALLERGIES: NKDA ANY MRI SCANS? NO THE PROCEDURE TO REMOVE THE DEVICE IS TENTATIVE FOR (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18356411 ↗
• InjuryDec 18, 2023Migration 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 THE LINX DEVICE ERODED INTO THE ESOPHAGUS AND WAS UNABLE TO BE CUT WITH WITH NORMAL PROCEDURE. THERE WERE THREE SURGERIES CONDUCTED TO GET IT DONE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Dysphagia/ Odynophagia; Pocket Erosion

  MAUDE report 18347693 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITHOUT EVENT DETAILS. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18318227 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITHOUT EVENT DETAILS. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18318226 ↗
• InjuryDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BECAME DISCONTINUOUS. IMPLANTED ON (B)(6) 2017. PATIENT HASN'T HAD EXPLANT DATE SCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 18300789 ↗

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-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-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