LINX LXC-[15]Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00855106005165), received between Nov 23, 2015 and Mar 18, 2022 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT TRX_2012_01: SUBJECT ID: (B)(6) EXPERIENCE, INCREASED REFLUX SYMPTOMS INCLUDING HEARTBURN AND REGURGITATION SINCE LAST ANNUAL VISIT. STARTED (B)(6) 2021, ONGOING AT TIME OF REPORT. THE SUBJECT HAD LINX IMPLANTED ON (B)(6)2014. MEDICATION: CHECKED PLEASE SPECIFY: PPI PRN. RELATIONSHIP TO THE DEVICE/PROCEDURE: YES/PROBABLY/POSSIBLY.

  Patient problems: Heartburn/Indigestion; Vomiting

  MAUDE report 13807732 ↗
• InjuryFeb 19, 2021Migration or Expulsion of Device; Device Appears to Trigger Rejection; Detachment of Device or Device Component; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Device Appears to Trigger Rejection; Detachment of Device or Device Component; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LINX IMPLANTED ON (B)(6) 2015 BY A DOCTOR, THE PATIENT HAS MOVED TO (B)(6), HAD VISITED RECENTLY WITH A PHYSICIAN IN (B)(6) WHO TOOK AN X-RAY SHOWING THE DEVICE IN A NON-CIRCULAR SHAPE. MODEL IS A .7T DEVICE.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion; Insufficient Information; Pain

  MAUDE report 11348549 ↗
• InjuryJun 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN LINX DEVICE WAS IMPLANTED ON (B)(6) 2015, DUE TO ACID REFLUX. SINCE THAT TIME, THE PATIENT HAS STARTED TO HAVE A RECURRENCE OF ACID REFLUX, PROBLEMS SWALLOWING AND CHEST PAINS. THE PATIENT CONSULTED WITH HER CARDIOLOGIST AND WAS REFERRED TO A GI CLINIC FOR TESTS. THE DEVICE IS STILL IMPLANTED.

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

  MAUDE report 10191953 ↗
• InjuryMar 5, 2020Patient-Device Incompatibility

  IT WAS REPORTED, "IN (B)(6) 2013, MY GI SURGEON TESTED THE SYMPTOMS FOR GERD AND DETERMINED I WAS PERFECT CANDIDATE FOR THE LINX DEVICE. AFTER WEARING THE DEVICE FOR SIX YEARS NOW, RECENTLY I'VE DEVELOPED PAIN, IRRITATION, AND BREATHING PRESSURE AT THE DEVICE LOCATION ON THE ESOPHAGUS. IN RECENT MONTHS, MY MEDICAL PROVIDERS HAVE PERFORMED A CT SCAN, COLONOSCOPY, ENDOSCOPY, ESOPHAGRAM, AND FLUOROSCOPIC EVALUATION OF ESOPHAGEAL MOTILITY. ALL OF THESE TEST RESULTS FOUND NO EVIDENCE OF OTHER MEDICAL ISSUES. THEREFORE, I'M CERTAIN THE LINX IS CAUSING MY EXTREMELY LOW QUALITY OF LIFE. MY GI SURGEON IS NO LONGER AT THE HOSPITAL. REQUESTING HOW TO GET THE LINX DEVICE REMOVED.

  Patient problems: No Code Available; Pain

  MAUDE report 9792994 ↗
• InjuryApr 1, 2019Unexpected Therapeutic Results; Patient-Device Incompatibility

  IT WAS REPORTED, CONTINUES TO MAINTAIN THE SAME ISSUES POST EXPLANT OF THE LINX DEVICE. IMPLANTED IN (B)(6) 2014 BY DR. (B)(6) AT (B)(6). EXPLANTED 18 MONTHS LATER BY DR. (B)(6) AT (B)(6) ON (B)(6) 2015. AFTER SIX MONTHS OF CONTINUOUS SEVERE PAIN, SCAR TISSUE GROWTH, AND ESOPHAGEAL SPASMS, THE PATIENT LOOKED FOR A SECOND OPINION BECAUSE DR. (B)(6) TOLD THE PATIENT TO KEEP WORKING THE DEVICE, THE PATIENT FOUND DR. (B)(6) AT (B)(6). THEY PRESCRIBED HER WITH MEDICATION TO ALLEVIATE THE PAIN. SIX MONTHS AFTER THE IMPLANT SHE WAS BARELY ABLE TO WORK. DR. (B)(6) TOLD HER TO DILATE THE SCAR TISSUE. IN TWELVE MONTHS, THEY DID FIVE DILATIONS. SHE KEPT TELLING HIM THAT MORE SCAR TISSUE WAS GROWING, AND HE DID NOT AGREE WITH HER. DURING THAT TWELVE MONTHS DR. (B)(6) CONDUCTED BARIUM SWALLOW STUDIES. THEY COULD SEE FOOD OR LIQUID POOL, OR SPASM ABOVE AND THEN FALL DOWN. THEY WOULD THEN DO ANOTHER DILATION. AFTER THE PATIENTS FIFTH DILATION SHE WAS IN SEVERE PAIN AND WAS UNABLE TO KEEP FOOD OR LIQUID DOWN, IT WOULD REACH THE DEVICE AND WOULD COME BACK UP. THEY DID ANOTHER BARIUM SWALLOW AND THAT WAS WHEN DR. (B)(6) REMOVED THE DEVICE. SHE HAS HAD TO CHANGE TO SOFT FOODS 24/7. SHE IS HAVING POOL

  Patient problems: No Code Available; Pain; Vomiting

  MAUDE report 8470114 ↗
• InjurySep 14, 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 ABDOMINAL PAIN 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 AND REPAIR OF A "SMALL SLIDING HIATAL HERNIA", MEASURING 1-2 CM OCCURRED WITHOUT ISSUE ON (B)(6) 2015. THE PATIENT REPORTED ON 07/16/2015 THAT SHE BEGAN TO EXPERIENCE MILD DYSPHAGIA, WHICH BEGAN (B)(6) 2015, AND A BARIUM SWALLOW "EXHIBITED LARYNGEAL PENETRATION SEEN WITH NUMEROUS SWALLOWS. THIS IMPROVED WITH CHIN TUCK. NO FRANK ASPIRATION. OTHERWISE, UNREMARKABLE ESOPHAGRAM STATUS POST-LINX PROCEDURE". THIS WAS RESOLVED BY (B)(6) 2016. THE PATIENT UNDERWENT MINI GASTRIC BYPASS PROCEDURE IN (B)(6) IN (B)(6) 2017 AND LOST 50 LBS SINCE THE PROCEDURE. AN EGD WITH PH TESTING OCCURRED ON (B)(6) 2017 WHERE THE PATIENT REPORTED REFLUX SYMPTOMS HAVE IMPROVED, AND SHE STOPPED TAKING OMEPRAZOLE IN (B)(6) 2017. THE EGD SHOWED GRADE B ESOPHAGITIS WITH "SHORT LINEAR ULCERS; WIDE OPEN" AND A GRADE 1 VALVE. PATHOLOGIC ANALYSIS OF GE JUNCTION BIOPSY SHOWED MILD CHRONIC INFLAMMATION. PH TESTING RESULTED IN DAY 1 ACID EXPOSURE OF 10.1% (DEMEEST

  Patient problems: Abdominal Pain; Heartburn/Indigestion

  MAUDE report 7876228 ↗
• InjurySep 7, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED 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 AND LINX DEVICE IMPLANTATION OCCURRED ON (B)(6) 2014 WITHOUT ISSUE. -THE PATIENT REPORTED ONGOING GERD SYMPTOMS AND THE DEVICE WAS EXPLANTED WITHOUT ISSUE AND A FUNDOPLICATION WAS PERFORMED ON (B)(6) 2018. -THE LINX DEVICE WAS IN THE CORRECT POSITION AND GEOMETRY.

  Patient problems: Heartburn/Indigestion

  MAUDE report 7854778 ↗
• InjuryMay 8, 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 A RECURRENT HIATAL HERNIA 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) 2015. DEVICE EXPLANT DUE TO ONGOING GERD OCCURRED ON 04/10/2018. A FULL HIATAL DISSECTION AND HERNIA REPAIR WAS PERFORMED. A REPLACEMENT LINX DEVICE WAS IMPLANTED AT THE TIME (MODEL: LXMC16, LOT: 19169). IT WAS NOTED THAT THE LINX DEVICE WAS FOUND "ABOVE THE HIATUS" WITH A RECURRENT PARAESOPHAGEAL HERNIA.

  Patient problems: Heartburn/Indigestion

  MAUDE report 7494147 ↗
• InjuryFeb 21, 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 A HIATAL HERNIA LEADING TO LINX DEVICE EXPLANT. 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. DEVICE EXPLANT DUE TO ONGOING GERD AND HIATAL HERNIA REPAIR. EXPLANT OCCURRED WITHOUT ISSUE ON (B)(6) 2017. THE DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY. AFTER DEVICE REMOVAL, A PARAESOPHAGEAL HERNIA REPAIR WAS PERFORMED AND A SECOND LINX DEVICE (MODEL: LXMC15, LOT # 17189) WAS IMPLANTED ON THE "DISTAL ESOPHAGUS ABOVE THE CARDIAC" WITHOUT ISSUE DURING THE SAME SURGERY.

  Patient problems: Heartburn/Indigestion; Hernia

  MAUDE report 7287210 ↗
• InjuryJan 19, 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 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. -DEVICE EXPLANT DUE TO ONGOING GERD AND MODERATE DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2017. -IT WAS OBSERVED THAT THE LINX WAS FOUND IN THE CORRECT POSITION/GEOMETRY, BUT LOW ON THE STOMACH WITH A HIATAL HERNIA. -AFTER DEVICE REMOVAL, A SECOND LINX DEVICE (MODEL: LXMC17, LOT# 16634) WAS IMPLANTED DURING THE SAME SURGERY.

  Patient problems: Heartburn/Indigestion

  MAUDE report 7207413 ↗
• InjuryNov 9, 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 DEMAGNETIZATION AND EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE INCLUDING HERNIA REPAIR AND 0.7T MRI COMPATIBLE LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2015. PATIENT UNDERWENT 1.5T MRI OF HIS HIP IMPLANTS ON (B)(6) 2016. REPORTED "PROGRESSIVELY WORSENING REFLUX" AND SOME DYSPHAGIA ON (B)(6) 2017. X-RAY FLUOROSCOPY OF THE ESOPHAGUS ON (B)(6) 2017 SHOWED "SPLAYING OF METALLIC BEADS OF PATIENT'S LINX DEVICE WITHOUT CONTRAST BOLUS" AND GASTROESOPHAGEAL REFLUX.. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 FOLLOWING DEMAGNETIZATION BY AN MRI MACHINE AND ONSET OF REFLUX AND DYSPHAGIA SYMPTOMS. DEVICE FOUND IN CORRECT POSITION AT THE TIME OF REMOVAL. A SECOND LINX DEVICE (MODEL: LXMC16, LOT # 14184) WAS IMPLANTED AT THE TIME OF SURGERY.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 7014590 ↗
• InjuryJul 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 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. -PATIENT HAD AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION ON (B)(6) 2016. -DEVICE EXPLANT DUE TO DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2017; A TOUPET FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6690193 ↗
• InjuryNov 10, 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 MODERATE 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. PRIOR TO EXPLANT PATIENT RECEIVED TWO DILATIONS TO TREAT DYSPHAGIA SYMPTOMS WITH LITTLE EFFECT. UNEVENTFUL DEVICE EXPLANT (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. FUNDOPLICATION PERFORMED IMMEDIATELY AFTER DEVICE EXPLANT. PATIENT REPORTED AS DOING WELL AFTER DEVICE EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6092985 ↗
• 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 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)(4) 2016. ESOPHAGEAL ENDOSCOPY WITH DILATION (THEE DIFFERENT ATTEMPTS) AND STEROIDS WERE PRESCRIBED TO ALLEVIATE POST ANTI-REFLUX PROCEDURE DYSPHAGIA. DEVICE EXPLANT (B)(6) 2016 DUE TO DYSPHAGIA. DEVICE FOUND IN CORRECT POSITION/GEOMETRY.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6073486 ↗
• InjuryDec 7, 2015Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA AND 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. PATIENT UNDERWENT GASTROESOPHAGEAL BALLOON DILATION (B)(6) 2015 WHICH DID NOT ALLEVIATE DYSPHAGIA SYMPTOMS. 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 5272080 ↗
• InjuryNov 23, 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) 2014 BY DR. (B)(6) AT (B)(6) HOSPITAL. -GASTROESOPHAGEAL BALLOON DILATION AFTER ANTI-REFLUX PROCEDURE WAS ATTEMPTED MULTIPLE TIMES BUT DID NOT FULLY ALLEVIATE DYSPHAGIA SYMPTOMS. -UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2015. -DEVICE FOUND IN CORRECT POSITION/GEOMETRY. -PATIENT IN SATISFACTORY CONDITION WITH SIGNIFICANT IMPROVEMENT IN SYMPTOMS AFTER EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5244712 ↗

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-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
• 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-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