LINX LS-[12]Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00855106005011), received between Apr 22, 2016 and Sep 23, 2019 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Erosion” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2019Material Erosion

  IT WAS REPORTED THAT THERE WAS A LINX EROSION. WE HAD THE PATIENT GO TO (B)(6), TO SEE A PHYSICIAN. PHYSICIAN TRIED YESTERDAY ((B)(6) 2019) TO REMOVE THE DEVICE AND WAS UNSUCCESSFUL. PATIENT IS GOING TO GO BACK IN THREE WEEKS, AND THEY ARE GOING TO TRY TO DO IT (REMOVE THE LINX DEVICE) ENDOSCOPICALLY. THE MODEL NUMBER IS LS12, LOT NUMBER WAS 3457 AND SERIAL NUMBER (B)(4).

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

  MAUDE report 9104019 ↗
• InjurySep 20, 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 MODERATE DYSPHAGIA 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 ON (B)(6) 2013. -UNEVENTFUL DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA WITH INTERMITTENT FOOD IMPACTIONS ON (B)(6) 2017. -LINX DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT THE TIME OF EXPLANT. -THE PATIENT RECEIVED A PARTIAL FUNDOPLICATION AT THE TIME OF EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6880227 ↗
• InjuryMar 28, 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 PAIN AND DYSPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF 2-3 LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN AND SUBSEQUENT DEVICE REMOVAL. 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) 2012 BY DR. (B)(6) AT (B)(6). -PATIENT BEGAN EXPERIENCING DYSPHAGIA IN (B)(6) 2017. -ENDOSCOPY CONFIRMED 2-3 LINX DEVICE BEADS VISIBLE AT THE PATIENT'S POSTERIOR SIDE OF THE ESOPHAGUS. -ENTIRE LINX DEVICE ENDOSCOPICALLY REMOVED WITHOUT ISSUE ON (B)(6) 2017 BY DR. (B)(6) AT (B)(6). -PATIENT REPORTED AS DOING WELL AFTER DEVICE EXPLANT.

  Patient problems: Erosion

  MAUDE report 6439236 ↗
• InjuryMar 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT REPORTED ONGOING GERD AND MODERATE DYSPHAGIA SYMPTOMS 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 LAPAROSCOPIC HERNIA REPAIR PRIOR TO REMOVAL; LINX DEVICE WAS NOTED AS IN GOOD POSITION AT THE GASTROESOPHAGEAL JUNCTION. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. AT THE TIME OF DEVICE EXPLANT, THE PATIENT RECEIVED A TOUPET FUNDOPLICATION.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 6370474 ↗
• InjuryJan 31, 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 SEVERE DYSPHAGIA 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) 2017 UPON PATIENT'S REQUEST FOR REMOVAL. -LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. -FUNDOPLICATION PERFORMED IMMEDIATELY AFTER DEVICE EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6290061 ↗
• InjuryDec 28, 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 GRADUAL DEVELOPING DYSPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF SEVEN LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN ON (B)(6) 2016 AND SUBSEQUENT DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2013. X-RAY EXAMINATION DUE TO DYSPHAGIA SYMPTOMS ON (B)(6) 2016 SHOWED THE LINX DEVICE IN AN "ODD POSITION" AND AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ALSO ON (B)(6) 2016 CONFIRMED AT LEAST SEVEN LINX DEVICE BEADS IN THE ESOPHAGEAL LUMEN. PATIENT WAS REPORTED AS ABLE TO SWALLOW SOFT FOODS AND LIQUIDS AT TIME OF EROSION DISCOVERY. UNEVENTFUL ENDOSCOPIC EXPLANT OF 6 LINX DEVICE BEADS ON (B)(6) 2016. PATIENT IS DOING WELL AND ONLY COMPLAINED OF A SORE THROAT AFTER SURGERY. UNEVENTFUL HERNIA REPAIR AND LAPAROSCOPIC EXPLANT OF REMAINING 6 LINX DEVICE BEADS ON (B)(6) 2017. PATIENT DOING WELL ON (B)(6) 2017; PRESCRIBED PROTONIX AND ZANTAC TO MANAGE REFLUX.

  Patient problems: Erosion

  MAUDE report 6209712 ↗
• InjuryDec 28, 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 EPIGASTRIC PAIN LEADING TO ENDOSCOPIC VISUALIZATION OF TWO 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. TWO DEVICE BEADS WERE OBSERVED ENDOSCOPICALLY ON (B)(6) 2016 IN THE LEFT SIDE OF THE ESOPHAGEAL LUMEN. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE EROSION MAY HAVE BEEN A STUCK PILL OF IBUPROFEN AT THE LEVEL OF THE DEVICE WHICH MAY HAVE THEN CREATED AN ULCER; THE PHYSICIAN DID NOT PROVIDE ANY DIRECT EVIDENCE TO SUPPORT THIS HYPOTHESIS HOWEVER. THE TWO BEADS WERE REMOVED ENDOSCOPICALLY WITH A LOOP-CUTTER ON (B)(6) 2016. THE PATIENT IS REPORTED AS DOING GREAT AFTER REMOVAL WITHOUT ANY REFLUX. THERE ARE NO PLANS BETWEEN THE PHYSICIAN AND PATIENT TO REMOVE THE REMAINING BEADS OF THE DEVICE AT THIS TIME.

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 6209316 ↗
• InjuryNov 2, 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 REFLUX, DYSPHAGIA AND ODYNOPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF TWO LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN IN (B)(6) 2016. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2012. THE PATIENT BEGAN EXPERIENCING PAINFUL SWALLOWING AND TROUBLE SWALLOWING IN (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT'S FOOD NEEDED TO BE PUREED, AND THAT THEY LOST WEIGHT. ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED IN (B)(6) 2016 DUE TO REFLUX, DYSPHAGIA, AND ODYNOPHAGIA SHOWED TWO LINX DEVICE BEADS IN THE ESOPHAGEAL LUMEN. UNEVENTFUL ENDOSCOPIC EXPLANT OF 3 LINX DEVICE BEADS ON (B)(6) 2016 AFTER PATIENT SECURED HEALTH INSURANCE. THE PHYSICIAN REMOVED THE REMAINING 9 BEADS ON (B)(6) 2016 AND REPORTED THAT "ALL WENT WELL," DURING THE EXPLANT. ON (B)(6)2016 THE PATIENT WAS REPORTED AS DOING WELL WITH "NO PROBLEMS" AFTER DEVICE EXPLANT. ON (B)(6)2018, IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE DYSPHAGIA AND ODYNOPHAGIA AFTER DEVICE REMOVAL AND HAS BEEN UNABLE TO WORK.

  Patient problems: Erosion

  MAUDE report 6073434 ↗
• InjuryApr 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 AND DECLINING ESOPHAGEAL MOTILITY 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) 2012 BY DR. (B)(6). GASTROESOPHAGEAL BALLOON DILATION WAS PERFORMED ON THREE DIFFERENT OCCASIONS AND DID NOT FULLY ALLEVIATE DYSPHAGIA SYMPTOMS. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2016 BY DR. (B)(6). DEVICE FOUND IN CORRECT POSITION/GEOMETRY.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5600485 ↗

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-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-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-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