LINX LXC-[13]Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00855106005141), received between Nov 30, 2015 and Jun 15, 2023 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A LINX WAS IMPLANTED IN 2014. THE PATIENT IS DONE REALLY WELL. THIS WAS ONE OF THE ORIGINAL DEVICES BEFORE WE HAD THE CLASP SHE WAS RECENTLY IN THE OFFICE FOR AN UNRELATED ISSUE, BUT IT DID INVOLVE A CHEST X-RAY, AND IT WAS NOTICED THAT HER DEVICE HAS BECOME DISCONTINUOUS. IN OTHER WORDS IT¿S GONE FROM A CIRCLE TO A C. CERTAINLY THERE HAS BEEN PROBABLY SOME DISRUPTION OF THE OLD MECHANISM THAT USED TO CLOSE THE DEVICE. UNK IF THE DEVICE IS GOING TO BE EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 17134217 ↗
• MalfunctionMay 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT TRX_2012_01 SUBJECT ID: (B)(6). A TRX_2012_01 SUBJECT HAS EXPERIENCED AN AE. SUBJECT ID: (B)(6). AE #: 7. ONSET DATE: (B)(6) 2023. DATE OF AE AWARENESS: (B)(6) 2023. EVENT DESCRIPTION: SUBJECT REPORTED DIFFICULTY SWALLOWING AND DIAGNOSED WITH OROPHARYNGEAL DYSPHAGIA. EVENT CHARACTERIZATION (FROM LISTING): DYSPHAGIA BLANK. AE STATUS/OUTCOME: RESOLVED. DATE RESOLVED: .(B)(6) 2023. DATE OF DEATH: BLANK. SEVERITY: MILD. ANTICIPATED: ANTICIPATED EVENT (SEE SECTION E ON NEXT PAGE). IS THE EVENT SERIOUS?: NO. DATE EVENT BECAME AN SAE: BLANK. RELATIONSHIP TO THE DEVICE/PROCEDURE: YES/PROBABLY/POSSIBLY. RISKS OF LINX DEVICE IMPLANTATION PROCEDURE AND/OR DEVICE: DYSPHAGIA. SPECIFY (IF OTHER IS SELECTED): BLANK. RISKS OF GENERAL SURGERY & ANESTHESIA: BLANK. SPECIFY (IF OTHER IS SELECTED): BLANK. HEALTHCARE UTILIZATION: NONE: BLANK. MEDICATION: CHECKED PLEASE SPECIFY: NEXIUM QD. NON-DRUG TREATMENT: BLANK LIST OF TREATMENTS: BLANK. OFFICE/CLINICAL VISIT: CHECKED DATE:(B)(6) 2023. MANOMETRY: BLANK DATE: BLANK . BARIUM ESOPHAGRAM: CHECKED DATE: (B)(6) 2023. EGD: BLANK DATE: BLANK . PH TESTING: BLANK DATE: BLANK. ER VISIT: BLANK DATE OF ADMISSION: BLANK.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 16938783 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LINX DEVICE WILL BE EXPLANTED DUE TO RECURRENT REFLUX SYMPTOMS.

  Patient problems: Heartburn/Indigestion

  MAUDE report 15762440 ↗
• InjuryNov 1, 2022Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT A LINX DEVICE WAS REMOVED DUE TO NEED FOR 3T MRI SCANS. DEVICE WAS A .7T CONDITIONAL DEVICE. HIATAL HERNIA REPAIR AND FUNDOPLICATION DONE. DEVICE HAD BEEN WORKING WELL WITH PATIENT TAKING PPI AS NEEDED.

  Patient problems: Hernia

  MAUDE report 15710416 ↗
• InjuryMay 31, 2022Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6): EXPERIENCE, ESOPHAGEAL SPASMS.  THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

  Patient problems: Abdominal Distention; Cramp(s) /Muscle Spasm(s); Diarrhea; Dysphagia/ Odynophagia; Heartburn/Indigestion; Pain; Pericarditis; Vomiting

  MAUDE report 14549950 ↗
• InjuryDec 12, 2020Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED DYSPHAGIA.

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

  MAUDE report 10994529 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINX IMPLANT DEVICE. REPORTS HAVING PAIN, DIFFICULTY SWALLOWING WITH WATER. A LOT OF TIGHTNESS IN THE CHEST AREA, NAUSEA AND SPASMS. IT IS UNKNOWN WHAT THE NEXT STEPS ARE WITH REGARDS TO TREATMENT.

  Patient problems: Chest Pain; Dysphagia/ Odynophagia; Heartburn/Indigestion; Muscle Spasm(s); Nausea; Vomiting

  MAUDE report 9843653 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SHARP EPIGASTRIC PAIN, NAUSEA DYSPHAGIA AND ODYNOPHAGIA FOR WHICH THEY WERE SEEN IN THE ER ON (B)(6) 2018. ON (B)(6) 2018: SAW SURGEON TO HAVE MOTILITY AND CT SCAN AND FOLLOW UP WITH THAT SURGEON. ON (B)(6) 2019: PATIENT SYMPTOMS RESOLVED AFTER STEROID BURST. HAS HAD MAYBE 3 "ESOPHAGEAL SPASMS" IN THE LAST. ON (B)(6) 2018: MOTILITY AND CT SCAN AND FOLLOW UP WITH THAT SURGEON. ON (B)(6) 2019: STEROID BURST YEAR, OTHERWISE FEELING WELL. THE PATIENT IS PART OF A CLINICAL STUDY. THE PATIENT IS WORKING HARD WITH THE SWALLOWING. BUT THE PATIENT THROWS UP ABOUT 1/2 OF WHAT THEY PUT DOWN AND HAVE LOST A LITTLE WEIGHT. NOTHING TERRIBLE. HAS GAG REFLEX TO FORCE OPEN THE LINX. SOMETIMES IT JUST DOESN'T OPEN UNLESS PATIENT THROWS UP AND START ALL OVER.

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

  MAUDE report 8811426 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANT (POST APPROVAL STUDY SUBJECT), PATIENT REPORTS SHARP PAIN IN THE EPIGASTRIC REGION. THE SUBJECT WENT TO THE ER AND WAS SUBSEQUENTLY ADMITTED. SUBJECT REPORTED HAVING AN X-RAY, ULTRASOUND, EGD AND LATER AN EGD WITH DILATION (COMPLETED APRIL 12 AT (B)(6) MEDICAL CENTER).

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 8607956 ↗
• InjuryMay 25, 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 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. PATIENT UNDERWENT SURGERY TO REPAIR A HIATAL HERNIA. PATIENT WENT BACK ON PPI FOR A "SMALL AMOUNT OF RECURRENT HEARTBURN". DEVICE EXPLANT DUE TO ONGOING GERD OCCURRED ON (B)(6) 2018. A FUNDOPLICATION WAS PERFORMED AT THE TIME OF REMOVAL. THE PATIENT STAYED OVERNIGHT AFTER DEVICE REMOVAL. DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY. IT WAS NOTED THAT THE "PATIENT HAD A LOT OF SCAR TISSUE DUE TO PREVIOUS SURGERIES. THE CAPSULE AROUND THE LINX WAS THICK AND COATED EACH BEAD INDIVIDUALLY." AN INTEROPERATIVE EGD (ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED SHOWING A "NORMAL ESOPHAGUS" POST-LINX REMOVAL.

  Patient problems: Heartburn/Indigestion

  MAUDE report 7543982 ↗
• 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, MODERATE DYSPHAGIA, AND REQUIRED A GASTRIC BYPASS PROCEDURE FOR WEIGHT LOSS 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 BY DR. (B)(6). DEVICE EXPLANT DUE TO ONGOING GERD, DYSPHAGIA, AND THE NEED FOR A GASTRIC BYPASS PROCEDURE. EXPLANT OCCURRED ON (B)(6) 2018 BY DR. (B)(6). A GASTRIC BYPASS WAS PERFORMED AT THE TIME OF EXPLANT. A SMALL HIATAL HERNIA WAS OBSERVED AT EXPLANT AND IT WAS NOTED THAT THERE WAS "SOME FUNDUS (1-2CM) ABOVE LINX."

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 7354682 ↗
• 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 WAS HOSPITALIZED FOR SEVERE CHEST PAIN. 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). PATIENT ADMITTED TO EMERGENCY ROOM ON (B)(6) 2017 WITH CHEST PAIN. THE PATIENT WAS GIVEN PPIS. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. PATIENT ADMITTED TO EMERGENCY ROOM ON (B)(6) 2017 WITH CHEST PAIN, AND DISCHARGED WITHIN 24-HOURS. PATIENT HOSPITALIZED FOR LESS THAN 24 HOURS ON (B)(6) 2018 WITH EPIGASTRIC PAIN WITH NAUSEA, DIZZINESS, SWEATINESS, AND SHORTNESS OF BREATH. AS OF (B)(6) 2018, THE PATIENT IS EXPERIENCING EPIGASTRIC PAIN, GASSINESS AND BLOATING, AND IS BEING MANAGED BY THEIR PHYSICIAN.

  Patient problems: Abdominal Pain

  MAUDE report 7287212 ↗
• InjuryFeb 1, 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 MODERATE DYSPHAGIA AND 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). -IT WAS NOTED THAT THE PATIENT "HAD AN EXCESSIVE AMOUNT OF INTRAPERITONEAL AND VISCERAL FAT" THAT MADE THE IMPLANT "MORE DIFFICULT THAN USUAL." -DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA AND ONGOING GERD OCCURRED ON (B)(6) 2017 BY DR. (B)(6). A FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPLANT. -IT WAS NOTED THAT THE DEVICE WAS FOUND TO BE ABOVE THE DIAPHRAGM, "PROBABLY DUE TO THE PARAESOPHAGEAL HERNIA."

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 7234858 ↗
• InjurySep 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 MILD 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, LINX DEVICE IMPLANTATION, AND USE OF MESH OCCURRED WITHOUT ISSUE ON (B)(6) 2015. DEVICE EXPLANT DUE TO MILD 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 6880322 ↗
• InjuryAug 29, 2017Adverse 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 SYMPTOMS 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 LINX DEVICE IMPLANT ON (B)(6)2015 BY DR. (B)(6). PRIOR TO DEVICE REMOVAL ON (B)(6) 2017, THE PATIENT HAD AN EGD WITH BALLOON DILATION UNDER FLURO TO 20MM. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 BY DR. (B)(6) DUE TO ONGOING GERD SYMPTOMS; PATIENT WAS ALSO EXPERIENCING BURNING IN THROAT, REGURGITATION, AND CHEST/EPIGASTRIC PAIN. DEVICE WAS FOUND ENCAPSULATED WITH MINIMAL ADHESIONS NOTED AND "EASILY IDENTIFIED AND LOOSE". LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. AT THE TIME OF DEVICE EXPLANT, THE PATIENT RECEIVED A FUNDOPLICATION.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6826532 ↗
• InjuryJun 21, 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 AND EPIGASTRIC PAIN SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF 2 LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN AND SUBSEQUENT PARTIAL DEVICE REMOVAL. 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) HOSPITAL. PATIENT HAD A NEW ONSET OF DYSPHAGIA AND EPIGASTRIC PAIN IN (B)(6) 2017. ENDOSCOPY CONFIRMED 2 LINX DEVICE BEADS VISIBLE AT THE PATIENT'S POSTERIOR SIDE OF THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. THE 6 OF 13 LINX DEVICE BEADS WERE ENDOSCOPICALLY REMOVED WITHOUT ISSUE ON (B)(6) 2017 BY DR. (B)(6) AND DR. (B)(6) AT (B)(6) HOSPITAL. THE PATIENT WAS REPORTED AS DOING WELL AFTER THE PARTIAL DEVICE REMOVAL. AN ATTEMPT TO REMOVE THE REMAINING DEVICE BEADS (7) WAS MADE ON (B)(6) 2017 BY DR. (B)(6); THE DEVICE WAS NOT ABLE TO BE EASILY EXPOSED (DUE TO ADHESIONS) AND THE CASE WAS ABANDONED. THE PATIENT WAS NO LONGER EXPERIENCING THE SYMPTOMS SHE HAD WHEN THE PARTIAL DEVICE WAS IN THE LUMEN.

  Patient problems: Erosion

  MAUDE report 6657150 ↗
• InjuryMay 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT HAD THE LINX DEVICE EXPLANTED FOR PAIN AND ASSOCIATED SPASMS. 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. PATIENT RECEIVED A DILATION ON (B)(6) 2016. PATIENT HAD LINX DEVICE REMOVED ON (B)(6) 2017. THE LINX DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF EXPLANT.

  Patient problems: Abdominal Pain

  MAUDE report 6595408 ↗
• InjuryMay 12, 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 CHEST 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 OCCURRED WITHOUT ISSUE ON (B)(6) 2014 BY DR. (B)(6). -UNEVENTFUL DEVICE EXPLANT DUE TO PAIN ON (B)(6) 2017 BY DR. (B)(6) 2017.

  Patient problems: Chest Pain

  MAUDE report 6564048 ↗
• InjuryJan 5, 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 RECURRENT GERD AND RELATED CHEST 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 IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2015. PATIENT BEGAN EXPERIENCING MODERATE HEARTBURN, AND CHEST/THROAT PAIN ON (B)(6) 2016. PATIENT HAD PAINS AND PLAQUES SUGGESTIVE OF CANDIDA ON (B)(6) 2016 AND WAS DETERMINED TO HAVE RECURRENT GERD. UNEVENTFUL DEVICE EXPLANT DUE TO RECURRENT GERD AND RELATED CHEST PAIN ON (B)(6) 2016. THE DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL. PATIENT UNDERWENT A HERNIA REPAIR AND FUNDOPLICATION IMMEDIATELY AFTER DEVICE EXPLANT.

  Patient problems: Chest Pain; Heartburn/Indigestion

  MAUDE report 6226591 ↗
• InjuryDec 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 MODERATE DYSPHAGIA RESULTING IN EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. PREVIOUS TO DEVICE EXPLANT AN EGD WITH DILATION WAS ATTEMPTED TWICE TO ALLEVIATE DYSPHAGIA SYMPTOMS. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2016. DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6159343 ↗
• 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 WITH ASSOCIATED GAS AND BLOATING LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. PATIENT EXPERIENCED MILD DAILY DYSPHAGIA BEFORE AND DURING DEVICE IMPLANT. UNEVENTFUL ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2014. PATIENT DECLINED TO PARTICIPATE IN PH TESTING PRIOR TO DEVICE EXPLANT. UNEVENTFUL DEVICE EXPLANT (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. AFTER EXPLANT THE PATIENT'S SYMPTOMS HAD NORMALIZED AND SHE WAS REPORTED AS DOING WELL.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5606384 ↗
• InjuryApr 20, 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 FROM ESOPHAGEAL SPASMS 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 BY (B)(6). PREVIOUS TO DEVICE EXPLANT THE PATIENT WAS PRESCRIBED SEVERAL STEROID TAPER PACKS AND TRIALED NUMEROUS ANTI-SPASMODICS WITHOUT ANY RELIEF OR IMPROVEMENT OF SYMPTOMS. PATIENT ALSO HAD MULTIPLE DILATIONS WITHOUT ANY IMPROVEMENT OF SYMPTOMS PRIOR TO DEVICE EXPLANT. UNEVENTFUL DEVICE EXPLANT DUE TO PAIN FROM ESOPHAGEAL SPASMS ON (B)(6) 2016. DEVICE FOUND IN CORRECT POSITION/GEOMETRY. DEVICE ANALYSIS CONDUCTED BY TORAX MEDICAL ENGINEERING AFTER PRODUCT RECEIPT. GROSS ANALYSIS REVEALED NO DEVICE ANOMALIES ATYPICAL FROM AN EXPLANTED DEVICE. MICROSCOPIC ANALYSIS REVEALED ALL DEVICE COMPONENTS AND ASSEMBLY EXHIBITED NORMAL CHARACTERISTICS OF AN EXPLANTED DEVICE. FORCE TESTING, LENGTH TESTING, AND GEOMETRIC ANALYSIS EXHIBITED NO ANOMALIES. NO CONCLUSION RELEVANT TO EXPERIENCE DETERMINED.

  Patient problems: Abdominal Pain

  MAUDE report 5588767 ↗
• InjuryJan 4, 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, PAIN AND LPR SYMPTOMS LEADING TO VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION REPORTED AS (B)(6) 2014. -PATIENT EXPERIENCED POST-OPERATIVE DYSPHAGIA TREATED VIA A SAVARY DILATOR AND SUBSEQUENT CHEST PAIN. -ENDOSCOPY COMPLETED (B)(6) 2015 DUE TO ONGOING LPR SYMPTOMS REVEALED SEVERAL BEADS (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. -ENDOSCOPIC REMOVAL OF ENTIRE DEVICE WAS CONDUCTED ON (B)(6) 2015. -PATIENT CONDITION REPORTED AS WELL FOLLOWING THE EXPLANT PROCEDURE.

  Patient problems: Abdominal Pain; Erosion; Heartburn/Indigestion

  MAUDE report 5342113 ↗
• InjuryNov 30, 2015Adverse 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 (B)(6) 2015 AT (B)(6). AFTER DEVICE REMOVAL, NISSEN FUNDOPLICATION COMPLETED WITHOUT ISSUE.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5255645 ↗

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-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
• 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