LINX LXMC16Recalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 00855106005363), received between Dec 14, 2015 and Mar 4, 2026 — classified as 159 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (62 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 167 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryOct 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT TRX_2018_01: 01137-007 EXPERIENCE, DYSPHAGIA. RELATIONSHIP TO STUDY DEVICE: PROBABLE.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 20358991 ↗
• InjuryJul 25, 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 THE DEVICE WAS BROKEN. PATIENT WAS SUFFERING FROM RECURRENT GERD'S. FOUND BROKEN AT TIME OF REMOVAL.

  Patient problems: Heartburn/Indigestion

  MAUDE report 19825835 ↗
• InjuryMay 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED DUE TO DYSPHAGIA. PATIENT RECEIVED TWO DILATIONS AND STEROIDS' PRIOR TO EXPLANT. PATIENT DOING WELL.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19277179 ↗
• MalfunctionApr 30, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A HUSBAND WAS CALLING ABOUT THE LINX COMPATIBILITY WITH MRI, BUT REPORTS THAT HIS WIFE HAD 1.5T LINX DEVICE IMPLANTED BETWEEN 2015-2018 BUT NEVER RECEIVED ANY RELIEF FROM HER GERD SYMPTOMS. SHE WAS PLACED BACK ON MEDICATION AND NEVER HAD EVALUATION OF THE DEVICE. SHE NOW HAS AN APPT WITH A SURGEON TO HAVE NISSEN FUNDOPLICATION PROCEDURE. CALLER ADVISED TO HAVE HIS WIFE SEE HER SURGEON TO EVALUATE LINX DEVICE AND REQUESTED MODEL AND LOT NUMBER TO DETERMINE IF HER DEVICE WAS PART OF THE RECALL AND MRI COMPATIBILITY. ON (B)(6) 2024 PATIENT'S HUSBAND RESPONDS TO EMAIL WITH MODEL AND LOT LXMC16 12721, WHICH WAS INCLUDED IN THE RECALL.

  Patient problems: Heartburn/Indigestion; Hernia

  MAUDE report 19212607 ↗
• InjuryApr 26, 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 IT WAS SEEN IN AN X-RAY THAT THE LINX DEVICE WAS DISCONTINUOUS. DEVICE IS STILL IMPLANTED.

  Patient problems: Inflammation; Insufficient Information; Vomiting

  MAUDE report 19190455 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE LINX DEVICE HAS BEEN CAUSING ESOPHAGEAL SPASMS AND GLOBUS SENSATION. LINX IMLANTED ON (B)(6) 2021 & EXPLANTED ON (B)(6) 2024. MEDICAL INTERVENTION: (B)(6) 2022 EGD- HIATAL HERNIA, (B)(6) 2022 PH IMPENDENCE DEMEESTER SCORE 75, (B)(6) 2023 MUCOSA C/WBE.

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

  MAUDE report 19151779 ↗
• InjuryApr 22, 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 THAT THE PATIENT HAS BEEN SUFFERING FROM ESOPHAGEAL SPASMS AND DYSPHAGIA, REFRACTORY TO MULTIPLE DILATIONS. DEVICE WAS IMPLANTED AT (B)(6).

  Patient problems: Cramp(s) /Muscle Spasm(s); Dysphagia/ Odynophagia

  MAUDE report 19151753 ↗
• MalfunctionMar 26, 2024Device Appears to Trigger Rejection; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A LINX INSTALLED (B)(6) 2020 AT HOSPITAL IN SAN ANTONIO, TX. PATIENT RECENTLY HAD A BAD EXPERIENCE IN AN MRI WHERE AN INTENSE STATIC ELECTRICITY TYPE SHOCK WAS SHOT THROUGH THEIR CHEST, ACCOMPANIED BY A PAINFUL FEELING PATIENT CAN ONLY DESCRIBE AS AN INTENSE ENERGY WAVE THAT BOUNCED/PULLED IN DIFFERENT DIRECTIONS IN THEIR CHEST. THE EXPERIENCE STARTED ALMOST IMMEDIATELY WHEN THE MACHINE SPUN UP AND ENDED QUICKLY WHEN PATIENT PUSHED THE EMERGENCY STOP BUTTON. IT WAS FOLLOWED BY AN INTENSE PERIOD OF NAUSEA. THE DEVICE STILL WORKS BUT PATIENT SOMETIMES EXPERIENCE MINOR REFLUX NOW WHICH HAD NOT HAPPENED SINCE INSTALLING THE DEVICE. THE MRI TECHNICIANS SAID THE MACHINE WAS RATED FOR 1.5T.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion; Nausea; Pain; Vomiting

  MAUDE report 18978346 ↗
• InjuryJan 25, 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 THAT THERE WAS A BARIUM- 4/18/18- ABNORMAL BARIUM SWALLOW. PASSAGE OF MATERIAL WAS HINDERED AT THE LEVEL OF THE LINX DEVICE AT THE GASTROESOPHAGEAL JUNCTION. BARIUM- 8/24/21-. NORMAL ESOPHAGEAL MOTILITY WAS OBSERVED WITH ADEQUATE CLEARING OF THE THIN LIQUID BARIUM BOLUS AND MECHANICAL SOFT FOOD BOLUS WITH TWO OR FEWER STRIPPING MOTIONS. INCOMPLETE CLEARING OF THE SOLID FOOD BOLUS REQUIRING MORE THAN TWO STRIPPING MOTIONS. SMALL HIATAL HERNIA SUGGESTED. BARIUM- 09/21/23 LINX FAILURE WITH SMALL RECURRENT HIATAL HERNIA. DELAYED ESOPHAGOGASTRIC CLEARANCE ON PRONE SWALLOW.

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

  MAUDE report 18582029 ↗
• InjuryJan 18, 2024Device Appears to Trigger Rejection; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Patient Device Interaction Problem

  IT WAS REPORTED THAT A LINX WAS IMPLANTED IN 2020. THE PATIENT EXPERIENCED SATISFACTORY REFLUX SYMPTOMS FOR THE FIRST YEAR AND FROM 2021-2023 THEY STARTED TO EXPERIENCE WORSE DYSPHAGIA AND IT BECAME UNBEARABLE FOR THE PATIENT UP TO THE POINT WHERE IT LED TO MALNOURISHMENT (AROUND 20 LBS.) AND ASPIRATION PNEUMONIA UPON EXPLANT DATE (B)(6) 2024.

  Patient problems: Dysphagia/ Odynophagia; Pneumonia; Weight Changes

  MAUDE report 18539539 ↗
• InjuryJan 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A LINX DEVICE IS BROKEN. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN IF THE DEVICE IS STILL IMPLANTED AND/OR IF ITS SCHEDULED FOR REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 18539052 ↗
• 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 18318220 ↗
• 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 18318208 ↗
• InjuryDec 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A LINX WAS REMOVED DUE TO DYSPHAGIA. ORIGINAL IMPLANT PROCEDURE WAS DONE ON (B)(6)/2019.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18300754 ↗
• InjuryNov 20, 2023Migration or Expulsion of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A LINX IMPLANTED YEARS AGO. SHE HAS RECURRENT GERD AND THE LINX IS MIGRATED INTO THE CHEST. SHE HAD AN X-RAY IN FEBRUARY WITH THE DEVICE INTACT. YESTERDAY SHE GOT HER PRE OP UGI AND THE LINX IS NOW DISRUPTED. NO CHANGE IN SYMPTOMS. SHE DOESN'T QUALITY FOR ANOTHER LINX BECAUSE OF SEVERE IEM.

  Patient problems: Heartburn/Indigestion

  MAUDE report 18169836 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LINX WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 18102164 ↗
• InjuryOct 18, 2023Device Appears to Trigger Rejection; Detachment of Device or Device Component; Device Appears to Trigger Rejection; Detachment of Device or Device Component

  IT WAS REPORTED THAT A LINX DEVICE WAS A YEAR AGO. THE PATIENT HAD SEVERE REGURGITATION AND PARAOESOPHAGEAL HERNIA BEFORE SURGERY. DID WELL, WAS DILATED TWICE FOR DYSPHAGIA WITH TEMPORARY RELIEF. PATIENT NOTED RETURN OF SYMPTOMS 4-6 WKS AGO, IMAGING SHOWED A DISCONTINUOUS DEVICE. THEY ARE UNSURE IF DEVICE WILL BE REPLACED, STILL IMPLANTED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 17957531 ↗
• InjuryOct 5, 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 A PATIENT WHO HAD A LINX DEVICE PLACED IN 2018, LAST WEEK PATIENT HEARD A SNAP IN HIS CHEST FOLLOWED BY PAIN AND X RAY SHOWED THE DEVICE IS BROKEN. THE DEVICE IS STILL IMPLANTED.

  Patient problems: Pain

  MAUDE report 17876360 ↗
• InjurySep 28, 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 THAT A LINX WAS EXPLANTED DUE TO DYSPHAGIA, ESOPHAGEAL SPASMS AND CONFIRMED DIAGNOSIS OF GASTROPARESIS.

  Patient problems: Cramp(s) /Muscle Spasm(s); Dysphagia/ Odynophagia; Paresis

  MAUDE report 17835757 ↗
• InjurySep 28, 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 THAT A LINX WAS EXPLANTED DUE TO DYSPHAGIA, ESOPHAGEAL SPASMS AND CONFIRMED DIAGNOSIS OF GASTROPARESIS.

  Patient problems: Cramp(s) /Muscle Spasm(s); Dysphagia/ Odynophagia; Paresis

  MAUDE report 17834616 ↗
• InjurySep 28, 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 A LINX WAS EXPLANTED DUE TO PERSISTENT GERD WITH DEMEESTER SCORE OF 74 AND EVIDENCE OF ESOPHAGITIS ON EGD, VEG 2/8/22: QUESTION OF POSSIBLE TINY RECURRENCE; NO ABNORMALITY OF THE LINX DEVICE AND NORMAL ESOPHAGEAL MOTILITY PER RADIOLOGY READ " EGD 10/17/22: ESOPHAGEAL FURROWING, HILL GRADE II, BRAVO 10/17/22: COMPOSITE SCORE 74, DAY 1 61, DAY 2 82. ESOPHAGEAL BXS: C/W EOE, PER OP NOTE: THE CHAIN WAS BROKEN AND THE LINX WAS REMOVED IN TWO PIECES. THE TROUBLESOME SYMPTOMS BEGAN ON (B)(6) 2022.

  Patient problems: Heartburn/Indigestion; Inflammation

  MAUDE report 17834542 ↗
• InjurySep 28, 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 A LINX WAS EXPLANTED DUE TO HEARTBURN AND CHEST PAIN., LINX IDENTIFIED AS BROKEN DURING OPERATION (B)(6) 2023.

  Patient problems: Heartburn/Indigestion; Pain

  MAUDE report 17834236 ↗

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-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
• 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