LINX LS-[13]Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00855106005028), received between Jun 19, 2015 and Aug 13, 2024 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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-2037-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF A 10 YEAR OLD LINX DEVICE. OVER TIME THE PATIENT WAS EXPERIENCING SOME LIMITED REFLUX. PATIENT REQUESTED THAT OLD DEVICE BE REMOVED AND REPLACED WITH A NEW LINX DEVICE. ORIGINAL DEVICE WAS A SIZE 13, THE NEW DEVICE IS A SIZE 16. A HIATAL HERNIA REPAIR WAS DONE AS WELL.

  Patient problems: Heartburn/Indigestion

  MAUDE report 19971233 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITHOUT EVENT DETAILS. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18318207 ↗
• InjuryAug 14, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE LINX IS POSSIBLY DISCONTINUOUS. FEW MONTHS OF HEARTBURN, REFLUX, BLOATING AND COUGHING UNTIL SHE WOULD VOMIT. HAS NOT HAD FOLLOW UP WITH OFFICE. DEVICE IS IMPLANTED.

  Patient problems: Abdominal Distention; Heartburn/Indigestion; Vomiting

  MAUDE report 17545350 ↗
• MalfunctionMay 25, 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 THAT THE PATIENT SUBMITTED A REQUEST FOR INFORMATION FORM ASKING "AFTER 5 YEARS, IF THE LINX IS REMOVED WILL THE TISSUE SURROUNDING THE LINX BEADS HAVE HAD TIME TO GROW AROUND THEM AND FIX THEM IN POSITION? IF THIS HAPPENS WILL EACH BEAD HAVE TO BE CUT OUT INDIVIDUALLY OR CAN THE BEADS STILL BE PULLED OUT ALL AT ONCE?" ERD NURSE LINE REPLIED WITH INFORMATION ABOUT THE LINX DEVICE AND REFERRED THEM TO THEIR DOCTOR.

  Patient problems: Cramp(s) /Muscle Spasm(s); Fatigue; Heartburn/Indigestion; Inflammation; Obstruction/Occlusion; Pain

  MAUDE report 14496962 ↗
• InjuryJun 23, 2021Migration or Expulsion of Device; Device Appears to Trigger Rejection; Migration or Expulsion of Device; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A LINX DEVICE IS SCHEDULED FOR EXPLANT (B)(6) 2021 DUE TO EROSION INTO THE ESOPHAGUS WHICH WAS FOUND BY AN ENDOSCOPY DONE BY A GI PARTNER. IMPLANTED (B)(6) 2013 IN (B)(6). PATIENT SINCE IMPLANTATION HAS REPORTED DYSPHAGIA AT DIFFERENT TIMES AND HAS HAD MULTIPLE ENDOSCOPIES PRIOR TO THE ONE WHICH FOUND THAT THE DEVICE HAD ERODED INTO THE ESOPHAGUS.

  Patient problems: Dysphagia/ Odynophagia; Pocket Erosion

  MAUDE report 12053215 ↗
• InjuryApr 7, 2021Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PREOPERATIVE TO LINX IMPLANT PROCEDURE, ON (B)(6) 2015, PATIENT WAS DIAGNOSED WITH GERD. PATIENT THEN HAD IMPLANTATION OF 13 LINX LOT #5149 WITH NO COMPLICATIONS. THE LINX DEVICE WAS IMPLANTED ON (B)(6) 2015. POST-APPROVAL STUDY PATIENT-REPORTED EXPERIENCING ITCHING AND BURNING IN HIS CHEST AND WAS DIAGNOSED WITH BILE REFLUX. THE PATIENT IS BEING REFERRED TO A GASTROENTEROLOGIST FOR FURTHER EVALUATION.

  Patient problems: Heartburn/Indigestion; Hernia; Itching Sensation; Pain

  MAUDE report 11627330 ↗
• InjuryMar 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED (B)(6) 2013 WITH A 13 BEAD SUTURED LINX DEVICE. THE PATIENT HAD COMPLAINED OF DYSPHAGIA X 2 MONTHS. UPON AN UPPER GI EXAM ON (B)(6) 2020, BEADS WERE NOTED IN THE ESOPHAGEAL LUMEN. THE ENTIRE DEVICE WAS REMOVED VIA AN ENDOSCOPIC PROCEDURE WITHOUT COMPLICATION.

  Patient problems: Dysphagia/ Odynophagia; Erosion; No Code Available

  MAUDE report 9896895 ↗
• InjuryFeb 6, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT, ¿LINX, LS13 DEVICE WAS EXPLANTED ON (B)(6) 2020 DUE TO PATIENT EXPERIENCING A RETURN OF GERD SYMPTOMS. A NISSEN FUNDOPLICATION WAS PERFORMED.

  Patient problems: Heartburn/Indigestion; Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 9677787 ↗
• InjuryAug 21, 2019Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD THE LINX IMPLANTED IN 2014. PATIENT WAS COMPLAINING ABOUT DYSPHAGIA AS THE REASON FOR DEVICE REMOVAL. PRIOR TO THE EXPLANT, DILATIONS AND STEROIDS WERE TRIED BUT DID NOT WORK. THE PHYSICIAN DID NOT HAVE ANY NOTABLE OBSERVATIONS. THE DEVICE WAS REMOVED WITHOUT INCIDENT.

  Patient problems: Dysphagia/ Odynophagia; No Code Available

  MAUDE report 8918253 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINX DEVICE WAS REMOVED ON (B)(6) 2018. DATE OF IMPLANT (B)(6) 2013. PATIENT HAS OTHER ORTHOPEDIC ISSUES, ONGOING GERD, SO THEY DECIDED TO TAKE THE LINX OUT. MULTIPLE ORTHOPEDIC ISSUES REQUESTING MRIS.

  Patient problems: No Code Available

  MAUDE report 8523135 ↗
• InjuryApr 27, 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) 2012. -DEVICE EXPLANT DUE TO ONGOING GERD OCCURRED ON (B)(6) 2018. -DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY. -PATIENT IS DOING "FINE" AS OF (B)(6) 2018.

  Patient problems: Heartburn/Indigestion

  MAUDE report 7467814 ↗
• 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 HAD AN ENDOSCOPIC VISUALIZATION OF 2 DEVICE BEADS ERODED INTO THE ESOPHAGEAL LUMEN AND SUBSEQUENT EXPLANT OF A PORTION OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE INCLUDING LINX DEVICE IMPLANT ON (B)(6) 2013 AT (B)(6) HOSPITAL. TWO (2) DEVICE BEADS WERE OBSERVED ENDOSCOPICALLY ON THE POSTERIOR SIDE OF THE ESOPHAGEAL LUMEN ON (B)(6) 2017. THE DEVICE WAS FOUND INTACT. SEVEN (7) OF THIRTEEN (13) LINX DEVICE BEADS WERE EXPLANTED ENDOSCOPICALLY ON (B)(6) 2017 AT (B)(6) SCHOOL OF MEDICINE. THE PATIENT WAS DOING WELL AFTER REMOVAL.

  Patient problems: Erosion

  MAUDE report 6826534 ↗
• InjuryMay 24, 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 ENDOSCOPIC VISUALIZATION OF 2 DEVICE BEADS ERODED INTO THE ESOPHAGEAL LUMEN AND SUBSEQUENT EXPLANT OF THE ENTIRE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE INCLUDING LINX DEVICE IMPLANTATION BY DR. (B)(6) IN 2013. THE 4 DEVICE BEADS WERE OBSERVED ENDOSCOPICALLY ON (B)(6) 2017 ON THE POSTERIOR SIDE OF THE ESOPHAGEAL LUMEN. THE LINX DEVICE WAS EXPLANTED TRANSGASTRICALLY IN ITS ENTIRETY BY DR. (B)(6) ON (B)(6) 2017. AT A STANDARD FOLLOW-UP VISIT ON (B)(6) 2017 THE PHYSICIAN REPORTED THAT THE PATIENT IS DOING WELL AND HAS RETURNED TO THEIR PRE-IMPLANT STATUS.

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 6587993 ↗
• 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 REQUIRED A MRI FOR UNRELATED CAUSES LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION DATE (B)(6) 2013 BY DR. (B)(6) AT (B)(6). UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 DUE TO NEED FOR AN UNRELATED MRI SCAN BY DR. (B)(6) AT (B)(6). THE PATIENT WAS ALSO EXPERIENCING SOME DYSPHAGIA AT THE TIME OF REMOVAL. DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL. PATIENT REPORTED AS DOING VERY WELL AFTER REMOVAL; DYSPHAGIA HAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6493361 ↗
• InjuryMar 15, 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, ESOPHAGEAL SPASMS, AND 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 ON (B)(6) 2015. PATIENT EXPERIENCED EPIGASTRIC PAIN STARTING ON (B)(6) 2016 AFTER ALMOST COMPLETE RESOLUTION OF PRE-EXISTING SYMPTOMS (HOARSENESS, HEARTBURN, CHEST PAIN, AND REGURGITATION). PATIENT RECEIVED A BALLOON DILATION ON (B)(6) 2017 WITH NO RELIEF. UNEVENTFUL DEVICE EXPLANT DUE TO PAIN FROM ESOPHAGEAL SPASMS ON (B)(6) 2017. PATIENT WAS REPORTED AS HAVING NO PAIN AFTER REMOVAL; HOWEVER, THE PHYSICIAN WAS MANAGING SOME DYSPHAGIA SYMPTOMS AND RETURN OF GERD.

  Patient problems: Abdominal Pain; Dysphagia/ Odynophagia

  MAUDE report 6407993 ↗
• InjuryDec 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT REQUIRED A MRI FOR UNRELATED CAUSES LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION DATE (B)(6) 2015 BY DR. (B)(6) AT (B)(6) HOSPITAL. -UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2016 DUE TO NEED FOR AN UNRELATED MRI SCAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6209169 ↗
• 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 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. LIBRAX, BACLOFEN, AND PRILOSEC PRESCRIBED TO TREAT DYSPHAGIA SYMPTOMS. DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. A FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6073634 ↗
• InjuryOct 14, 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 NAUSEA LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. PATIENT EXPERIENCED DYSPHAGIA BEFORE DEVICE IMPLANT THAT REQUIRED DILATIONS ON AT LEAST 2 OCCASIONS. UNEVENTFUL ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2012. UNEVENTFUL DEVICE EXPLANT (B)(6) 2016. IMMEDIATELY AFTER DEVICE EXPLANT THE PATIENT HAD A REPLACEMENT LINX DEVICE IMPLANTED. PATIENT IS REPORTEDLY "DOING GREAT!" AFTER IMPLANTATION OF A REPLACEMENT LINX DEVICE. PATIENT REPORTS THAT NAUSEA, ACID REFLUX AND HEARTBURN HAVE BEEN RESOLVED.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6030170 ↗
• InjurySep 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 DYSPHAGIA AND ASSOCIATED 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) 2014. PATIENT REPORTED DYSPHAGIA SYMPTOMS PRIOR TO DEVICE IMPLANT. UNEVENTFUL DEVICE EXPLANT DUE TO MILD DYSPHAGIA ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. FUNDOPLICATION PERFORMED AT THE TIME OF EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5940608 ↗
• InjuryAug 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 DYSPHAGIA AND SOME 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. EGDS AND DILATIONS PERFORMED ON (B)(6) 2014, AND (B)(6) 2015 PRIOR TO EXPLANT. DEVICE EXPLANT OCCURRED WITHOUT ISSUE ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. FUNDOPLICATION PERFORMED IMMEDIATELY AFTER LINX DEVICE EXPLANT.

  Patient problems: Dysphagia/ Odynophagia; Heartburn/Indigestion

  MAUDE report 5857200 ↗
• InjuryAug 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 EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE INCLUDING HIATAL HERNIA REPAIR AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2012. DILATIONS PERFORMED IN (B)(6) 2012, (B)(6) 2016 PRIOR TO EXPLANT. DEVICE EXPLANT OCCURRED WITHOUT ISSUE ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. PATIENT'S DYSPHAGIA SYMPTOMS HAVE IMPROVED AFTER EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5839731 ↗
• InjuryJun 3, 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) 2014. AFTER IMPLANT THE PATIENT REFUSED DILATIONS TO TREAT DYSPHAGIA. UNEVENTFUL DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. DYSPHAGIA REPORTED AS RESOLVED AFTER DEVICE EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5697399 ↗
• InjuryMar 23, 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 AND RELATED REGURGITATION AND LIMITED ESOPHAGEAL CLEARANCE 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. PATIENT UNDERWENT GASTROESOPHAGEAL BALLOON DILATION (B)(6) 2015 WHICH DID NOT ALLEVIATE DYSPHAGIA SYMPTOMS. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2016. DEVICE FOUND IN CORRECT POSITION/GEOMETRY. PATIENT UNDERWENT TOUPET FUNDOPLICATION AT TIME OF DEVICE EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5521001 ↗
• InjuryMar 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT REQUIRED A MRI FOR UNRELATED CAUSES LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION DATE (B)(6) 2013 INCLUDING HIATAL HERNIA REPAIR BY DR. (B)(6) AT (B)(6). DEVICE WAS REPORTED AS WORKING PROPERLY. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2016 DUE TO NEED FOR AN UNRELATED MRI SCAN. DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL. DEVICE WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5520761 ↗
• InjuryNov 30, 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) 2012. GASTROESOPHAGEAL BALLOON DILATION ATTEMPTED TO ADDRESS POST PROCEDURAL DYSPHAGIA DID NOT ALLEVIATE SYMPTOMS. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2015. DEVICE WAS ABLE TO BE REMOVED FROM FIBROUS CAPSULE IN A SINGLE PULL. DEVICE FOUND IN CORRECT POSITION/GEOMETRY. DEVICE AND ANATOMY FOUND TO HAVE CHANGED ORIENTATION AT TIME OF EXPLANT. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5256062 ↗

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-2038-2018 · Apr 20, 2018 · Terminated
  LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product C
• 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-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