LINX LS-[15]Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00855106005042), received between Oct 17, 2016 and Feb 15, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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. 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-2037-2018 · Root cause: Nonconforming Material/Component · Recall details · 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.

• InjuryFeb 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DUE TO BEING ELECTROCUTED THE PATIENT HAD THE LS15 EXPLANTED AND IT LOOKED LIKE THE ELASTIC BAND HAD MELTED. PATIENT HAD TO GO BACK ON MEDICATION, PROTONIC.

  Patient problems: Electric Shock; Insufficient Information

  MAUDE report 16378446 ↗
• MalfunctionOct 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE THE LINK DEVICE WAS EXPLANTED ON (B)(6) 2020 SO THAT THE PATIENT COULD GET AN MRI.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10662379 ↗
• InjuryJun 1, 2018Malposition of Device; Malposition of Device

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ONGOING GERD SYMPTOMS THAT LEAD TO X-RAY VISUALIZATION OF THE LINX DEVICE OPEN. THIS LED TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE INCLUDING AN INTEROPERATIVE ENDOSCOPY AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2009. A BIOPSY WAS PERFORMED AT THE TIME SHOWING PERITONEAL MESOTHELIOMA. PATIENT'S ONGOING GERD SYMPTOMS BEGAN IN (B)(6) 2014. X-RAY ON (B)(6) 2017 LEAD TO THE INITIAL VISUALIZATION OF THE DISCONTINUOUS DEVICE. X-RAY SHOWED THAT THE DEVICE WAS INTACT; HOWEVER, BEAD-TO-BEAD SEPARATION WAS LARGER THAN NORMAL. FURTHER REVIEW OF PREVIOUS X-RAYS, SHOW THAT THE DISCONTINUATION OCCURRED BETWEEN (B)(6) 2013 AND (B)(6) 2014. DEVICE EXPLANT DUE TO THE DEVICE OPENING OCCURRED WITHOUT ISSUE ON (B)(6) 2018. A REPLACEMENT LINX WAS IMPLANTED AT THE TIME (MODEL: LXMC16, LOT#: 17685). IT WAS NOTED THAT "BOTH TIE KNOTS WITH SUTURE (STRETCHED BETWEEN) WERE PRESENT - NOT DISCONTINUOUS PER SE" AND THAT THE "SUTURES WERE STILL INTACT WITH BOTH TIE KNOTS ON THE ENDS OF THE DEVICE WERE SEPARATED BY MORE SPACE THAN EXPECTED. SO, ON THE X

  Patient problems: Heartburn/Indigestion

  MAUDE report 7562488 ↗
• InjuryJan 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 EXPERIENCED MILD DYSPHAGIA AND ONGOING GERD SYMPTOMS 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) 2012. -DEVICE EXPLANT DUE TO MILD DYSPHAGIA AND ONGOING GERD OCCURRED ON (B)(6) 2017; A FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPLANT. -DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 7228627 ↗
• InjuryJan 11, 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 ONGOING GERD AND 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 HERNIA REPAIR AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2014 BY DR. (B)(6). DEVICE EXPLANT DUE TO ONGOING GERD AND MODERATE DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2017 BY DR. (B)(6); A FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPLANT. DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 7182921 ↗
• InjuryOct 11, 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) 2015. DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2017; A FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPLANT. DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6942159 ↗
• 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 EXPERIENCED ONGOING GERD SYMPTOMS RESULTING IN 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. PATIENT WAS SYMPTOM FREE UNTIL THE RETURN OF GERD SYMPTOMS 4 MONTHS PRIOR TO REMOVAL. PATIENT HAD AN UPPER GI ON (B)(6) 2017 AND A LINX BEAD WAS BELIEVED TO HAVE ERODED THROUGH THE PATIENT'S ESOPHAGUS. DEVICE EXPLANT DUE TO ONGOING GERD ON (B)(6) 2017; THE DEVICE HAD NOT ERODED THROUGH THE ESOPHAGUS. A FOREIGN BODY (INCLUDING BLUE MONOFILAMENT SUTURE) UNASSOCIATED WITH THE LINX DEVICE WAS FOUND APPROXIMATELY 1 CM FROM THE GASTROESOPHAGEAL JUNCTION. THE DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL. PATIENT UNDERWENT A FUNDOPLICATION IMMEDIATELY AFTER DEVICE EXPLANT.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6370418 ↗
• InjuryFeb 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 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) 2016. -UNEVENTFUL DEVICE EXPLANT (B)(6) 2017. THE PATIENT UNDERWENT A FUNDOPLICATION IMMEDIATELY AFTER EXPLANT. -LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. -PATIENT REPORTED AS DOING WELL AFTER REMOVAL.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6343209 ↗
• InjuryOct 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 PAIN AND ASSOCIATED "BURNING" SENSATION 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 ON (B)(6) 2014. UNEVENTFUL DEVICE EXPLANT DUE TO PAIN ON (B)(6) 2015. THE PATIENT'S SYMPTOMS HAVE RESOLVED AFTER EXPLANT.

  Patient problems: Abdominal Pain

  MAUDE report 6033758 ↗

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-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-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-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