LINX LXC-[14]Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00855106005158), received between Jun 19, 2015 and Aug 30, 2022 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED A 40 YEAR OLD MALE WITH SYMPTOMS OF GERD, IBS, ANXIETY, DEPRESSION. THE LINX PROCEDURE IMPLANT WAS AROUND 9 YEARS AGO. RECURRENT SYMPTOMS OF GERDS. PATIENT REPORTS HE BEGAN FEELING RECURRENT SYMPTOMS IN SUMMER 2021, DESCRIBED AS A GENERALIZED ABDOMINAL FULLNESS ACCOMPANIED WITH MILD NAUSEA. HE ALSO EXPERIENCED INTERMITTENT HEARTBURN. HE IS PRESENTLY TAKING OMEPRAZOLE 40 MG ONCE DAILY WITH MILD RELIEF. BRAVO (B)(6) 2022 SHOWED ABNORMAL LEVELS OF ACID REFLUX. THE DEVICE IS NO LONGER PROVIDING HIM WITH RELIEF OF SYMPTOMS.

  Patient problems: Abdominal Distention; Anxiety; Depression; Heartburn/Indigestion; Nausea

  MAUDE report 15320230 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A LINX DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO DYSPHAGIA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion; No Code Available; Vomiting

  MAUDE report 10454934 ↗
• InjuryMar 19, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LINX DEVICE WAS EXPLANTED ON (B)(6) 2020 DUE TO RECURRING GERD AND A HIATAL HERNIA. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Heartburn/Indigestion; Hernia; No Code Available

  MAUDE report 9856053 ↗
• InjuryJul 15, 2019Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT POST-IMPLANT, SINCE LINX IMPLANT, PATIENT HAS BEEN NOT COMPLETELY SATISFIED WITH THE CONTROL OF HER LPR SYMPTOMS PARTICULARLY THROAT CLEARING. PATIENT REPORTS OVER THE YEARS IT APPEARED TO BE WORSE DESPITE TAKING PEPCID LEADING THE PATIENT TO DECIDE TO PURSUE EXPLANT AT GEORGETOWN HOSPITAL. IT IS UNKNOWN IF THERE WERE ANY ADVERSE PATIENT CONSEQUENCES. ADDITIONALLY, PPI'S AND H2 BLOCKERS WERE PRESCRIBED. THE PATIENT WAS CONVERTED TO A NISSEN AFTER THE LINX EXPLANT. SHE IS DOING WELL AND IS OFF PPI/H2 BLOCKERS AND IS ASYMPTOMATIC.

  Patient problems: No Code Available

  MAUDE report 8789219 ↗
• InjuryMay 16, 2019Unexpected Therapeutic Results

  IT WAS REPORTED THAT AFTER A LINX 14 CLASP IMPLANT PROCEDURE, (LOT# 4525 SERIAL# (B)(4)) THE PATIENT REPORTED CONTINUED PRESENCE OF REFRACTORY HEARTBURN AND REGURGITATION. THE PATIENT WANTED TO MOVE FORWARD WITH EXPLANT. THE PHYSICIAN EXPLANTED THE LINX AND CONVERTED TO A NISSEN FUNDOPLICATION. THEY PATIENT STAYED OVERNIGHT. PAS SUBJECT (B)(6).

  Patient problems: No Code Available; Vomiting

  MAUDE report 8617128 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LINX EXPLANT PROCEDURE WAS DONE ON (B)(6) 2018 (LXC14, SERIAL # (B)(4), LOT #5931). HISTORY: LINX DEVICE IMPLANT DATE WAS ON (B)(6) 2014. BACK ON (B)(6) 2018 THE EGD SHOWS LINX IS IN GOOD POSITION. GASTRITIS WAS SEVERE (LA GRADE D, PYLORIC AND DUODENAL ULCERS NOTED). PATIENT STARTED ON CARAFATE AND OMEPRAZOLE. ON (B)(6) 2018 THE PATIENT WAS EXPERIENCING HEARTBURN, UPPER GASTRIC PAIN AND SEVERE BLOATING AND FEELS HIS LINX DEVICE IS NOT WORKING FOR HIM. ON (B)(6) 2018 PATIENT WAS SEEN AT OFFICE TO DISCUSS OPTIONS. ON (B)(6) 2018 EXPLANT UNDERTAKEN BASED MOSTLY ON HIS PEPTIC ULCER DISEASE. PATIENT WAS CONVERTED TO A LAP TOUPE NISSEN.

  Patient problems: Abdominal Distention; No Code Available; Pain; Ulcer

  MAUDE report 7985117 ↗
• InjuryJul 7, 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 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 ON AN UNKNOWN DATE IN 2014 BY DR. (B)(6) AT (B)(6). -DEVICE EXPLANT DUE TO DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2016 BY DR. (B)(6); A TOUPET FUNDOPLICATION WAS PERFORMED IMMEDIATELY AFTER EXPLANT. -DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL. -PATIENT WAS REPORTED AS HAVING NO DYSPHAGIA AS OF A FOLLOW UP APPOINTMENT ON (B)(6) 2016.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6693801 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT REQUIRED MRI(S) FOR UNRELATED CAUSES LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE INCLUDING LINX DEVICE IMPLANTATION AND HERNIA REPAIR ON (B)(6) 2015. -UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 DUE TO NEED FOR A 3.0T MRI. -DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL. -FUNDOPLICATION PERFORMED IMMEDIATELY AFTER EXPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693784 ↗
• InjuryMar 22, 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 MILD DYSPHAGIA AND THROAT PAIN 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 IMPLANT ON (B)(6) 2013 BY DR. (B)(6) AT (B)(6) HOSPITAL. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 BY DR. (B)(6) AT (B)(6) HOSPITAL. DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL. PATIENT IS REPORTED AS DOING WELL AND SWALLOWING BETTER AFTER REMOVAL.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6425554 ↗
• InjuryJan 6, 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 MILD DYSPHAGIA AND RELATED PAIN 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 BY DR. (B)(6) AT (B)(6) HOSPITAL. -DEVICE EXPLANT (B)(6) 2016 DUE TO MILD DYSPHAGIA AND RELATED PAIN BY DR. (B)(6) AT (B)(6) MEDICAL CENTER. -DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT TIME OF EXPLANT.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 6229056 ↗
• InjuryNov 9, 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) 2014. PATIENT REPORTED BLOATING AND GERD SYMPTOMS AS WORSE THAN BASELINE. UNEVENTFUL DEVICE EXPLANT (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. PATIENT REPORTED AS WELL.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6091456 ↗
• InjurySep 13, 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 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) 2015. DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5946180 ↗
• InjuryJul 11, 2016Adverse 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 REQUESTED LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL ANTI-REFLUX PROCEDURE, HERNIA REPAIR, AND DEVICE IMPLANT ON (B)(6) 2015. UNEVENTFUL DEVICE EXPLANT (B)(6) 2016 AT PATIENT'S REQUEST DESPITE A NORMAL BRAVO PH TEST. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. AFTER DEVICE REMOVAL AND AT THE PATIENT'S REQUEST THE PATIENT RECEIVED A NISSEN FUNDOPLICATION.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5783819 ↗
• InjuryMay 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 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 NISSEN FUNDOPLICATION IMMEDIATELY AFTER DEVICE EXPLANT.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5661522 ↗
• InjuryJan 21, 2016Insufficient Device Problem Information

  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 (B)(6) 2015. -LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. -AFTER DEVICE REMOVAL, PATIENT UNDERWENT NISSEN FUNDOPLICATION.

  Patient problems: No Code Available

  MAUDE report 5384367 ↗
• InjuryOct 20, 2015Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED 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) 2015. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2015. DEVICE FOUND IN CORRECT POSITION/GEOMETRY. PATIENT UNDERWENT FUNDOPLICATION AT TIME OF DEVICE EXPLANT. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5162446 ↗
• InjurySep 22, 2015Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED "FIERY TONGUE" 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) 2014. POST ANTI-REFLUX PROCEDURE SYMPTOMS WERE TREATED VIA STEROIDS, BACLOFEN, AND BALLOON DILATION WITH LIMITED SUCCESS. UNEVENTFUL DEVICE EXPLANT (B)(6) 2015. LINX DEVICE FOUND IN CORRECT LOCATION/GEOMETRY. PATIENT IS REPORTED AS WELL AFTER DEVICE EXPLANT.

  Patient problems: Burning Sensation

  MAUDE report 5095484 ↗
• InjuryJun 19, 2015Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PT EXPERIENCED DISCOMFORT LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. PHYSICIAN INDICATED PT HAD VERY UNUSUAL COMPLAINTS THAT PT ATTRIBUTED TO LINX DEVICE AND INSISTED ON REMOVAL DESPITE PHYSICIAN COUNSELING. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2015. DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT TIME OF EXPLANT. PT IN SATISFACTORY CONDITION AFTER EXPLANT.

  Patient problems: Abdominal Pain

  MAUDE report 4860168 ↗

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-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-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