LINX LXC-[16]Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00855106005172), received between Jan 5, 2016 and Sep 16, 2019 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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-2038-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT HAD REPLACEMENT OF HIS LINX TODAY. THIS WAS A MINIMAL DISSECTION PROCEDURE INITIALLY AND DEVELOPED IN TO A PEH. TODAY THE PEH WAS REPAIRED. DR. WANTED IT NOTED THAT THE ONLY REASON TO REPLACE THE LINX WAS BECAUSE HE HAD A 1.5T DEVICE. LINX DEVICE EXPLANTED AND REPLACED WITH NEW LINX DEVICE.

  Patient problems: Abdominal Distention; Dysphagia/ Odynophagia; Nausea; No Code Available; Pain; Vomiting

  MAUDE report 9072319 ↗
• InjuryMar 20, 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, MILD DYSPHAGIA, AND REFLUX WITH ASPIRATION LEADING TO LINX DEVICE EXPLANT. 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. PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT ON (B)(6) 2017 WITH DYSPNEA, AND WAS DIAGNOSED WITH ASPIRATION PNEUMONIA AND SEPSIS. DEVICE EXPLANT DUE TO ONGOING GERD, DYSPHAGIA, AND REFLUX WITH ASPIRATION. EXPLANT OCCURRED WITHOUT ISSUE ON (B)(6) 2017. A FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPLANT. DURING EXPLANT AND THEN HIATAL HERNIA REPAIR WITH MESH, IT WAS OBSERVED THAT "IT APPEARED THAT THE LINX DEVICE HAD ACTUALLY RE-HERNIATED POSTERIORLY WITH SOME POSTERIOR STOMACH AS WELL HERNIATED THROUGH A RECURRENT DEFECT POSTERIORLY" AND THAT "THE ESOPHAGUS AND CAPSULE FOR THE LINX HAD SCARRED INTO THE MEDIASTINUM."

  Patient problems: Aspiration/Inhalation; Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 7354684 ↗
• InjuryJan 18, 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 DELAYED GASTRIC EMPTYING, "SEVERE CHEST PAIN," WEIGHT LOSS, VOMITING, MODERATE DYSPHAGIA, AND ONGOING GERD LEADING TO THE REMOVAL OF A 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 BY DR. (B)(6). - DEVICE EXPLANT DUE TO DELAYED GASTRIC EMPTYING, CHEST PAIN, WEIGHT LOSS, VOMITING, MODERATE DYSPHAGIA AND ONGOING GERD OCCURRED WITHOUT ISSUE ON (B)(6) 2017 BY DR. (B)(6). A FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPLANT. -DEVICE WAS FOUND IN CORRECT POSITION/GEOMETRY. - A "SMALL HIATAL HERNIA WAS APPRECIATED ON FURTHER DISSECTION" DURING DEVICE EXPLANT.

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

  MAUDE report 7204484 ↗
• InjuryOct 18, 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 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) 2014 BY DR. (B)(6) AT (B)(6). -DEVICE EXPLANT DUE TO ONGOING GERD OCCURRED WITHOUT ISSUE ON (B)(6) 2017 BY DR. (B)(6) AT (B)(6). -LINX DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT THE TIME OF EXPLANT. -PATIENT REPORTED AS DOING WELL AFTER REMOVAL.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6960002 ↗
• InjuryJul 19, 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 WITH LINX DEVICE IMPLANT ON (B)(6)2015 BY DR. (B)(6). -PRIOR TO REMOVAL, THE PATIENT WAS EXPERIENCING SOME ESOPHAGEAL DYSMOTILITY, DISTAL ESOPHAGEAL DIVERTICULUM, SEVERE REGURGITATION, AND NAUSEA. -DEVICE EXPLANT (B)(6)2017 BY DR. (B)(6) DUE TO SEVERE DYSPHAGIA; PATIENT ALSO EXPERIENCING ONGOING GERD SYMPTOMS, ESOPHAGEAL SPASMS, DEHYDRATION, AND PO INTOLERANCE. -DEVICE WAS FOUND IN THE CORRECT/POSITION GEOMETRY AT THE TIME OF REMOVAL; IT WAS NOTED THERE WAS "SIGNIFICANTLY DILATED PROXIMAL ESOPHAGUS". -PATIENT REPORTED AS DOING OKAY AFTER EXPLANT.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 6726295 ↗
• InjuryApr 25, 2017Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ONGOING GERD AND MODERATE DYSPHAGIA LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL ANTI-REFLUX PROCEDURE INCLUDING HERNIA REPAIR AND DEVICE IMPLANT ON (B)(6) 2013. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017; LINX DEVICE NOTED AS DENSELY ENCAPSULATED AT TIME OF REMOVAL. DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT TIME OF EXPLANT. IMMEDIATELY AFTER DEVICE EXPLANT THE PATIENT HAD A REPLACEMENT LINX DEVICE IMPLANTED (MODEL: LXMC17).

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 6518735 ↗
• InjuryApr 14, 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) 2015. -UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 DUE TO ONGOING GERD SYMPTOMS. DEVICE WAS NOTED AS TILTED DOWNWARDS ANTERIORLY AND 1-2 CM BELOW THE GASTROESOPHAGEAL JUNCTION; INVESTIGATION FOUND THAT THE SURGEON BELIEVED HE MISPLACED THE LINX DEVICE DURING IMPLANT. REMOVAL SURGERY INCLUDED A HERNIA REPAIR. -AFTER DEVICE REMOVAL, A HIATAL HERNIA REPAIR WAS PERFORMED AND A SECOND LINX DEVICE (MODEL: LXMC16, LOT # 8178, SERIAL # (B)(4)) WAS IMPLANTED WITHOUT ISSUE DURING THE SAME SURGERY.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6493342 ↗
• InjuryJan 4, 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 MILD DYSPHAGIA 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) 2013 BY DR. (B)(6) AT (B)(6) HOSPITAL. -UNEVENTFUL DEVICE EXPLANT DUE TO "SEVERE" RETROSTERNAL PAIN AND MILD DYSPHAGIA ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6) CLINIC. -DEVICE FOUND IN CORRECT POSITION/GEOMETRY. -A FUNDOPLICATION WAS PERFORMED IMMEDIATELY AFTER EXPLANT. -APPROXIMATELY ONE AND HALF WEEKS AFTER EXPLANT THE PATIENT REPORTED NO RESIDUAL PAIN, NO REFLUX SYMPTOMS, AND HASN'T TAKEN ANY PPIS.

  Patient problems: Abdominal Pain; Patient Problem/Medical Problem

  MAUDE report 6223074 ↗
• InjuryNov 21, 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 AND EPIGASTRIC PAIN LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE WITH HIATAL HERNIA REPAIR AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2014. UNEVENTFUL DEVICE EXPLANT DUE TO ONGOING GERD ON (B)(6) 2016. PATIENT UNDERWENT A FUNDOPLICATION IMMEDIATELY AFTER DEVICE EXPLANT.

  Patient problems: Abdominal Pain; Heartburn/Indigestion

  MAUDE report 6118400 ↗
• InjuryApr 25, 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. PATIENT UNDERWENT A 1.5T MRI 2 WEEKS AFTER IMPLANT; THE IMPLANT IS 0.7T CONDITIONAL AND CONSIDERED UNSAFE IN A 1.5T MRI. PATIENT RECEIVED A DILATION APPROXIMATELY 5 MONTHS AFTER IMPLANT. UNEVENTFUL DEVICE EXPLANT (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. AFTER DEVICE REMOVAL, A SECOND LINX DEVICE WAS IMPLANTED (MODEL LXMC15, LOT NUMBER 9132, (B)(4)) WITHOUT ISSUE.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5606394 ↗
• InjuryJan 5, 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 AN UNRELATED HEAD INJURY. THE HEAD INJURY REQUIRES A 3 TESLA MRI SCAN AND THEREFORE 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 UNKNOWN. DEVICE WAS REPORTED AS WORKING PROPERLY. UNEVENTFUL DEVICE EXPLANT DUE TO NEED FOR AN UNRELATED 3 TESLA MRI SCAN ON (B)(6) 2015. DEVICE WAS DISCARDED. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT. NISSEN FUNDOPLICATION PERFORMED AFTER DEVICE EXPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5345158 ↗

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-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-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