LINX LS-[14]Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00855106005035), received between Aug 25, 2015 and Dec 13, 2023 — classified as 24 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 18318236 ↗
• InjuryJun 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE LINX EXPLANT PROCEDURE THAT THE SURGEON NOTICED THERE WAS NO CLASP THAT THE DEVICE LOOKED DIFFERENT. STATED THIS COULD BE AN OLDER MODEL. IMPLANT DATE WAS IN 2016.

  Patient problems: Insufficient Information

  MAUDE report 17175048 ↗
• InjuryMar 28, 2023Device 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 LINX DEVICE WAS PLACED IN 2014. IN 2018, THE PATIENT HAD AN ESOPHAGEAL DILATION WHICH ALLEVIATED HER SYMPTOMS. SIX MONTHS AGO, THE PATIENT BEGAN HAVING SEVERE CHEST PAIN, AND FOOD BEGAN GETTING STUCK, EVEN SOMETHING SMALL LIKE PILL. IMMEDIATELY AFTER EATING, THE PATIENT HAS PAIN AND HAS TO BEND OVER TO TRY TO FORCE OUT AIR AND THAT CAUSES THE CHEST PAIN. THE PATIENT REPORTS UPPER STOMACH PAIN. THE PATIENT HAS AN APPOINTMENT WITH A GI DOCTOR IN APRIL.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 16629006 ↗
• InjuryMay 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A YEAR OR SO AGO, THE PATIENT NOTICED ON THE WEBSITE THAT MRI WITH MAGNETS OF 1.5 TESLA STRENGTH WAS OK FOR PATIENTS WITH LINX AND MORE RECENTLY THE PATIENT SEES THAT STATEMENT HAS BEEN QUALIFIED TO READ THAT 1.5 TESLA STRENGTH MAGNET IS OK FOR PATIENTS IMPLANTED AFTER SEP, 2015. IT IS THE PATIENTS UNDERSTANDING THAT THE RECOMMENDATIONS ON THE TORAX WEBSITE ARE BASED CHIEFLY ON PHYSICS CALCULATIONS AND DO NOT NECESSARILY REFLECT REPORTS OF INJURY IN PATIENTS WHO HAVE HAD MRIS WITH MAGNETS OF A HIGHER THAN RECOMMENDED STRENGTH. THE PATIENT RECEIVED A LINX IN (B)(6) 2015. THE PATIENT WONDERED IF THERE ARE REPORTS OF PATIENTS WITH LINX IMPLANTS FROM THIS PERIOD WHO HAVE TOLERATED MRI WITH MAGNET STRENGTH EXCEEDING 0.7 TESLA. THE PATIENT WONDERS IF ACCUMULATED PATIENT EXPERIENCE SUGGESTS YOUR RECOMMENDATIONS MAY BE OVERLY CAUTIOUS. THE PATIENT ALSO WOULD LIKE TO MENTION THAT THEIR PERSONAL EXPERIENCE WITH DYSPHAGIA AFTER LINX HAS BEEN DIFFERENT THAN THAT DESCRIBED ON TORAX WEBSITE. THE PATIENT STILL HAVE BOUTS OF DYSPHAGIA 3+ YEARS AFTER RECEIVING LINX AND 2 YEARS AFTER ESOPHAGEAL DILATATION. THE EPISODES ARE MOST LIKELY TO OCCUR IN RESTAURANTS, WHEN EATING DRY FOO

  Patient problems: Anxiety; Dysphagia/ Odynophagia

  MAUDE report 14516029 ↗
• InjuryJul 10, 2020Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF GERD AFTER HAVING THE LINX DEVICE IMPLANTED ON (B)(6) 2009. AN XRAY WAS TAKEN AND IT WAS DISCOVERED THAT THE LINX DEVICE WAS DISCONTINUOUS AND IN A C SHAPE. IT HAS NOT BEEN DETERMINED IF THE PATIENT WILL HAVE THE DEVICE REMOVED DUE TO THE PATIENT BEING DIAGNOSED WITH CANCER.

  Patient problems: Heartburn/Indigestion; No Code Available

  MAUDE report 10258327 ↗
• InjuryJun 24, 2020Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A DEVICE EROSION AND EXPLANT PROCEDURE THAT THE DEVICE ERODED INTO THE ESOPHAGUS. NO NEW DEVICE WAS IMPLANTED. PATIENT EXPERIENCED POST-OP RETCHING WHICH CAUSE THEM TO RETURN TO THE HOSPITAL SEVEN DAYS AFTER THE PROCEDURE. PATIENT IS CURRENTLY STABLE AND WAS DISCHARGED (B)(6) 2020. THE 14 BEAD DEVICE WAS REMOVED LAPAROSCOPICALLY. IN ORDER TO RELEASE THE DEVICE, THE SUTURES WERE CUT. ON (B)(6) 2020 UNDER ENDOSCOPY THERE WAS NOT FULL THICKNESS EROSION PRESENT BUT PATIENT PRIMARY COMPLAINT WAS DYSPHAGIA AND PAIN. PATIENT RETURNED ON (B)(6) 2020 UNDER ENDOSCOPY 4-5 BEADS WERE PRESENT IN THE ESOPHAGEAL LUMEN AT WHICH POINT THE DEVICE WAS LAPAROSCOPICALLY REMOVED. ON (B)(6) 2020 PATIENT RETURNED TO OR WHERE A PARAESOPHAGEAL HERNIA WAS REPAIRED.

  Patient problems: Dysphagia/ Odynophagia; Erosion; Heartburn/Indigestion; Hernia; Inflammation; No Code Available; Not Applicable; Pain; Pleural Effusion

  MAUDE report 10188871 ↗
• InjuryMay 7, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LINX REMOVAL AND REPLACEMENT PROCEDURE, THE PATIENT HAD RETURNED TO HAVE THE SUTURE TYPE, 14 BEAD LINX DEVICE REMOVED BECAUSE THE PATIENT HAD AN MRI PROCEDURE AND THE LINX DEVICE BECAME DEMAGNETIZED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Code Available

  MAUDE report 8587789 ↗
• InjuryJan 5, 2019Protective Measures Problem

  IT WAS REPORTED THAT THE LINX DEVICE WAS IMPLANTED IN 2016. THE PATIENT HAS DEVELOPED REOCCURRING REFLUX POST-OPERATIVE. THE PATIENTS DOCTOR DID AN X-RAY AND FOUND THAT THE DEVICE WAS NOT CONTINUOUS AND INFORMED THE PATIENT THAT THE DEVICE NEEDED TO BE EXPLANTED. THERE IS NO DATE SCHEDULED FOR THE EXPLANT AT THIS TIME.

  Patient problems: Heartburn/Indigestion; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8220503 ↗
• InjuryOct 15, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS AN EXPLANT AND CONVERSION TO FUNDOPLICATION THAT HAPPENED LAST WEEK. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 7966851 ↗
• InjuryFeb 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 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 LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2013 AT (B)(6) MEDICAL CENTER (B)(6) BY DR. (B)(6). THE PATIENT RECEIVED "A COUPLE DILATIONS FOR DYSPHAGIA". DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2018. DEVICE WAS FOUND IN CORRECT POSITION/GEOMETRY. THE PATIENT IS "DOING GREAT" AS OF (B)(6) 2018.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 7271316 ↗
• InjuryJul 28, 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 SYMPTOMS LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -UNEVENTFUL ANTI-REFLUX PROCEDURE INCLUDING LINX DEVICE IMPLANTATION ON (B)(6) 2013. -UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2015; IT WAS NOTED THERE WAS A SMALL PARAESOPHAGEAL HERNIA AND ADHESIONS IN THE UPPER ABDOMEN 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: LXMC14, LOT: 8413, SERIAL: (B)(4)).

  Patient problems: Heartburn/Indigestion

  MAUDE report 6751355 ↗
• InjuryJun 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 SYMPTOMS 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)2013; A SMALL HIATAL HERNIA WAS PRESENT BUT NOT REPAIRED. -DEVICE EXPLANT DUE TO ONGOING GERD ON (B)(6)2017; DEVICE WAS FOUND WITHIN A HIATAL HERNIA. -PATIENT UNDERWENT A FUNDOPLICATION IMMEDIATELY AFTER DEVICE EXPLANT.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6640570 ↗
• InjuryOct 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 ABDOMINAL PAIN TO ENDOSCOPIC VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN ON (B)(6) 2016. 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) 2012 BY DR. (B)(6). -A HIATAL HERNIA WAS REPAIRED AS PART OF THE ANTI-REFLUX PROCEDURE. -PATIENT REPORTED DIFFICULTIES SWALLOWING/DYSPHAGIA AFTER DEVICE IMPLANT. -ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2016 SHOWED LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. -UNEVENTFUL ENDOSCOPIC EXPLANT OF SINGLE LINX BEAD ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6). -PHYSICIAN PLANS TO LAPAROSCOPICALLY REMOVE THE REMAINDER OF THE LINX DEVICE IN (B)(6) 2017. PATIENT REPORTED AS DOING WELL.

  Patient problems: Erosion

  MAUDE report 6048972 ↗
• InjuryOct 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 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 IN (B)(6) 2012. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2015; IT WAS NOTED THAT THE LOCATION OF EXPLANTED DEVICE APPEARED TO BE SLIGHTLY HERNIATED THROUGH THE HIATUS. HIATAL HERNIA REPAIR AFTER DEVICE IMPLANT (PRIOR TO DEVICE REPLACEMENT). A REPLACEMENT LINX DEVICE WAS IMMEDIATELY AFTER EXPLANT OF THE ORIGINAL DEVICE. THE PATIENT IS REPORTEDLY DOING BETTER WITH ONLY MINOR DYSPHAGIA.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6048960 ↗
• InjuryOct 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 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) 2012. UNEVENTFUL DEVICE EXPLANT DUE TO ONGOING GERD ON (B)(6) 2016. DEVICE FOUND IN CORRECT POSITION/GEOMETRY. PATIENT UNDERWENT A FUNDOPLICATION IMMEDIATELY AFTER DEVICE EXPLANT.

  Patient problems: Heartburn/Indigestion

  MAUDE report 6014013 ↗
• InjuryMay 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 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. DILATION PERFORMED ON (B)(6) 2016 PRIOR TO EXPLANT. TESTS PRIOR TO DEVICE EXPLANT SHOWED NO REFLUX AND NO MOTILITY DISORDER. PATIENT DECLINED FURTHER PHYSICIAN RECOMMENDED INVESTIGATION AND REQUESTED THE DEVICE BE REMOVED. UNEVENTFUL DEVICE EXPLANT DUE TO MILD ORAL-PHARYNGEAL DYSPHAGIA ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5645277 ↗
• InjuryApr 7, 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 PROGRESSIVE DYSPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN ON (B)(6) 2016. 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) 2013 BY (B)(6). ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2015 DUE TO PROGRESSIVE DYSPHAGIA SHOWED NO FINDINGS. A SECOND EGD DUE TO PROGRESSIVE DYSPHAGIA WAS PERFORMED ON (B)(6) 2016 AND SHOWED 3-4 BEADS VISIBLE IN THE ESOPHAGEAL LUMEN. UNEVENTFUL ENDOSCOPIC DEVICE EXPLANT ON (B)(6) 2016 AFTER PATIENT COMPLETED SCHEDULED VACATION. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

  Patient problems: Erosion

  MAUDE report 5555315 ↗
• InjuryJan 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 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. UNEVENTFUL DEVICE EXPLANT (B)(6) 2015. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. AFTER DEVICE REMOVAL, PATIENT UNDERWENT NISSEN FUNDOPLICATION.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5358940 ↗
• 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 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 DATE AND HOSPITAL LOCATION UNKNOWN. -ESTIMATED IMPLANT DURATION REPORTED AS TWO YEARS. -PATIENT REPORTED AS REQUIRING SURGERIES FOR AORTIC DISSECTION. -UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2014. DEVICE WAS DISCARDED. -DEVICE FOUND IN CORRECT POSITION/GEOMETRY. -PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT. DYSPHAGIA SYMPTOMS RESOLVED; PATIENT EXPERIENCED ONGOING GERD AND DELAYED GASTRIC EMPTYING.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 5345061 ↗
• InjuryDec 18, 2015Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT HAD THE LINX DEVICE REMOVED DUE 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) 2012 IN (B)(6). ENDOSCOPIC REMOVAL OF ENTIRE INTACT LINX DEVICE WAS CONDUCTED (B)(6) 2015 BY (B)(6). PATIENT CONDITION REPORTED AS SATISFACTORY.

  Patient problems: Abdominal Pain; Erosion

  MAUDE report 5311932 ↗
• InjuryNov 4, 2015Adverse Event Without Identified Device or Use Problem

  FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED REGURGITATION/ASPIRATION 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 IN SATISFACTORY CONDITION AFTER EXPLANT.

  Patient problems: Aspiration/Inhalation; Regurgitation

  MAUDE report 5202120 ↗
• InjuryOct 20, 2015Insufficient 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) 2014. -UNEVENTFUL DEVICE EXPLANT (B)(6) 2015. -LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. -AFTER DEVICE REMOVAL, A SECOND LINX DEVICE WAS IMPLANTED (MODEL LXMC14, LOT NUMBER 8957, SERIAL NUMBER (B)(4)).

  Patient problems: No Code Available

  MAUDE report 5162464 ↗
• InjuryOct 15, 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. DEVICE IMPLANT BY DR. (B)(6). UNEVENTFUL DEVICE EXPLANT (B)(6) 2015 BY DR. (B)(6). THE EXPLANTING SITE REPORTED THAT IT APPEARED THE LINX MAY HAVE BEEN IMPLANTED BELOW THE TARGET LOCATION. A FUNDOPLICATION WAS PERFORMED AT THE TIME OF DEVICE EXPLANT.

  Patient problems: Heartburn/Indigestion

  MAUDE report 5151455 ↗
• InjuryAug 25, 2015Adverse 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) 2012 AT (B)(6) WITH DR. (B)(6) AS IMPLANTING SURGEON. -UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2015. -DEVICE FOUND IN CORRECT POSITION/GEOMETRY. -NISSEN FUNDOPLICATION PERFORMED IMMEDIATELY AFTER EXPLANT OF LINX DEVICE. -PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

  Patient problems: Abdominal Pain

  MAUDE report 5028528 ↗

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-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