LINX LXC-[17]Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00855106005189), received between Dec 7, 2015 and Nov 12, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Nonstandard 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. 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-2038-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2019Nonstandard Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP THAT POST IMPLANT TO A LINX DEVICE THE PATIENT'S GERD SYMPTOMS RETURNED. THE DEVICE WAS EXPLANTED ON (B)(6) 2019, AND THE PATIENT WAS CONVERTED TO A NISSEN.

  Patient problems: Heartburn/Indigestion; No Code Available

  MAUDE report 9310174 ↗
• InjuryAug 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 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) 2015. COUNSELLING AND ESOPHAGEAL DILATION PERFORMED POST ANTI-REFLUX PROCEDURE TO TREAT DYSPHAGIA. DIAGNOSTIC BARIUM SWALLOWS SHOWED NO SIGNIFICANT STRICTURE OR HOLD-UP OF CONTRAST. DEVICE EXPLANT AT PATIENT'S REQUEST ON (B)(6) /2016 DUE TO DYSPHAGIA. DYSPHAGIA HAS RESOLVED TO PRE-ANTI-REFLUX PROCEDURE STATUS.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5894467 ↗
• InjuryDec 7, 2015Adverse 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 DATE NOT REPORTED. -UNEVENTFUL DEVICE EXPLANT DUE TO ONGOING GERD ON (B)(6) 2015. -DEVICE FOUND IN CORRECT POSITION/GEOMETRY. -PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5272343 ↗

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-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-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-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