LINX LS-[16]Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00855106005059), received between Nov 4, 2015 and May 30, 2019 — classified as 6 injuries.

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-2037-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LS16 LINX DEVICE IMPLANTED SIX YEARS AGO, DUE TO REFLUX. THE PATIENT ALSO HAD A HIATAL HERNIA, DURING THE IMPLANT, THAT WAS NOT REPAIRED WITH THE IMPLANT OF THE LINX. ON (B)(6) 2019, THE PATIENT'S HIATAL HERNIA HERNIATED, AND A HIATAL HERNIA REPAIR WAS PERFORMED AND THE LS16 LINX DEVICE WAS EXPLANTED AND AN LXMC17 LINX DEVICE WAS REPLACED. THERE WERE NO ABNORMAL OBSERVATIONS. THE SAME DOCTOR PERFORMED BOTH PROCEDURES.

  Patient problems: No Code Available

  MAUDE report 8655407 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT WAS HOSPITALIZED FOR NAUSEA, CHEST PAIN, AND BECAUSE SHE WAS "UNABLE TO KEEP FOOD OR LIQUIDS DOWN." THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE INCLUDING LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2015. PATIENT ADMITTED TO HOSPITAL ON (B)(6) 2015. THE PATIENT WAS GIVEN PHENERGAN AND SILDENAFIL. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. PATIENT HAD AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION ON (B)(6) 2015 AND "DID VERY WELL FOR 24-26 HOURS AND THEN STARTED TO DEVELOP PAIN AGAIN." AT THE 6-MONTH FOLLOW-UP, THE PATIENT INDICATED THAT THE ISSUE HAD BEEN RESOLVED AND SHE WAS NO LONGER EXPERIENCING ANY PROBLEMS.

  Patient problems: Abdominal Pain; Nausea

  MAUDE report 7385002 ↗
• InjuryJun 21, 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 ONGOING GERD SYMPTOMS LEADING TO A LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL ANTI-REFLUX PROCEDURE INCLUDING DEVICE IMPLANTATION AND HERNIA REPAIR ON (B)(6) 2014. PATIENT HAD LINX DEVICE REMOVED DUE TO ONGOING GERD SYMPTOMS ON (B)(6) 2017. DR. (B)(6) NOTED THE DEVICE "SEEMED SLIGHTLY LOW WITH RESPECT TO THE SCJ (SQUAMOCOLUMNAR JUNCTION) AT SURGERY" AND IT WAS "POSSIBLE THAT IT TILTED". THERE WAS A "SUBSTANTIAL FIBROTIC REACTION AROUND THE DEVICE" AT THE TIME OF REMOVAL. A FUNDOPLICATION WAS PERFORMED IMMEDIATELY AFTER EXPLANT.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6657171 ↗
• InjurySep 26, 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 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. UNEVENTFUL DEVICE EXPLANT DUE TO ONGOING GERD ON (B)(6) 2016. DEVICE FOUND IN CORRECT POSITION/GEOMETRY. PATIENT UNDERWENT A FUNDOPLICATION IMMEDIATELY AFTER DEVICE EXPLANT.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5978429 ↗
• InjuryMay 10, 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) 2013. 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. PATIENT REPORTED SEVERE COUGHING FIT IN (B)(6) 2015 THAT CORRELATED TO THE RETURN OF REFLUX SYMPTOMS. AFTER DEVICE REMOVAL, PATIENT UNDERWENT NISSEN FUNDOPLICATION.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5645237 ↗
• InjuryNov 4, 2015Adverse 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. ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2014. PATIENT EXPERIENCED ONGOING GERD WITH SUBSEQUENT DEVICE X-RAY (B)(6) 2015. BARIUM ESOPHAGRAM APPEARED TO SHOW DEVICE SUTURES WERE TIED LOOSELY ALLOWING DEVICE TO OPEN SLIGHTLY LARGER THAN TYPICAL DURING LES EXPANSION. NO ADVERSE EVENT OR SYMPTOMS DETERMINED TO CORRELATE TO THIS OBSERVATION. UNEVENTFUL DEVICE EXPLANT (B)(6) 2015. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY WITH RESPECT TO LES. IT WAS REPORTED ANATOMY WITH DEVICE WAS ABOVE THE DIAPHRAGM LIKELY DUE TO HERNIATION. AFTER DEVICE REMOVAL, A SECOND LINX DEVICE WAS IMPLANTED (MODEL LXC16, LOT NUMBER 6396, SERIAL NUMBER (B)(4)) WITHOUT ISSUE.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 5200647 ↗

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-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
• 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