EsophyX ZRecalls & reported problems across all models

We found 2 models of EsophyX Z by Endogastric Solutions, Inc. in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2016 and Jun 5, 2026 — classified as 1 death, 54 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EsophyX Z recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 14, 2025Open, Classified

   Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

   Z-1640-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported EsophyX Z problems

EsophyX Z models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EsophyX Z+ R2007

  Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
  1 recall1 death69 reports
• EsophyX Z R2006

  Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
  6 reports

Recent EsophyX Z adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  A LITERATURE SEARCH FOR THE ESOPHYX DEVICE PRODUCT FAMILY REVEALED A PATIENT WHO DEVELOPED ASPIRATION PNEUMONIA COMPLICATED BY FLASH PULMONARY EDEMA REQUIRING POST-PROCEDURE HOSPITALIZATION AND MEDICAL MANAGEMENT FOR FIVE DAYS FOLLOWING THE TIF PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pneumonia; Pulmonary Edema

  MAUDE report 25408787 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE ESOPHYX DEVICE PRODUCT FAMILY. THE CASE REPORT BY ABBASI ET AL. (B)(6) 2026) DESCRIBES A 39-YEAR-OLD MALE WHO DEVELOPED HEMODYNAMIC INSTABILITY AND MELENA TWO DAYS AFTER TRANSORAL INCISIONLESS FUNDOPLICATION USING THE ESOPHYX DEVICE. THE PATIENT REQUIRED INTRAVENOUS FLUIDS, TWO UNITS OF PACKED RED BLOOD CELLS, REPEAT ENDOSCOPY, CAUTERIZATION OF A FORREST IIA GASTRIC CARDIA ULCER, AND ADDITIONAL HEMOSTATIC CLIPS BEFORE RECOVERING.

  Patient problems: Hemodynamic instability; Melena

  MAUDE report 25398263 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE ESOPHYX DEVICE PRODUCT FAMILY. THE STUDY BY KEIHANIAN ET AL. (2026) RETROSPECTIVELY PROCEDURES PERFORMED USING THE ESOPHYX-Z DEVICE. ONE PATIENT DEVELOPED PERSISTENT ABDOMINAL PAIN AND WAS FOUND TO HAVE PNEUMOPERITONEUM ON COMPUTED TOMOGRAPHY WITHOUT EVIDENCE OF AN APPARENT LEAK. THE PATIENT WAS MANAGED CONSERVATIVELY.

  Patient problems: Abdominal Pain

  MAUDE report 25398251 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE ESOPHYX DEVICE PRODUCT FAMILY. THE STUDY BY HODGENS ET AL. (2025) THE AUTHORS REPORTED ONE INTRAOPERATIVE PROXIMAL ESOPHAGEAL PERFORATION, WHICH WAS MANAGED NONOPERATIVELY.

  Patient problems: Internal Organ Perforation

  MAUDE report 25398221 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  A LITERATURE SEARCH FOR THE ESOPHYX DEVICE FAMILY WAS PERFORMED AND A STUDY, "TRANSORAL INCISIONLESS FUNDOPLICATION IN THE UNITED KINGDOM: INITIAL OUTCOMES AND LEARNING CURVE EXPERIENCE" BY NORTON ET AL. (2025), REPORTED ONE EVENT IN WHICH A PATIENT DEVELOPED AN ESOPHAGEAL PERFORATION WITH PERI-ESOPHAGEAL FLUID COLLECTION FOLLOWING USE OF THE ESOPHYX DEVICE. THE EVENT REQUIRED HOSPITAL ADMISSION AND TREATMENT WITH INTRAVENOUS ANTIBIOTICS.

  Patient problems: Perforation of Esophagus

  MAUDE report 25374833 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  CUSTOMER REPORTS AFTER INSERTING THE DEVICE AND CONFIRMING THE POSITION, THEY WENT TO SCREW IN THE HELIX. AFTER APPROXIMATELY TWO TO THREE TURNS, THE HELIX ANCHOR WAS DETACHED FROM THE WIRE. THIS RESULTED IN THEM HAVING TO REMOVE THE DEVICE, OPEN A SECOND KIT AND RETRIEVE THE DETACHED ANCHOR IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645284 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THE PHYSICIANS SUCCESSFULLY PERFORMED A CONCOMITANT HIATAL HERNIA REPAIR WITH ENDOSCOPIC FUNDOPLICATION (CTIF) ON (B)(6) 2024 WITHOUT COMPLICATIONS. NO MEDICAL DEVICE MALFUNCTION NOTED. APPROXIMATELY 13 DAYS LATER, THE PATIENT RETURNED TO MEDICAL CENTER REPORTING CHEST PAIN. A CT SCAN IN THE EMERGENCY DEPARTMENT REVEALED A SUSPECTED ABSCESS, LIKELY CAUSED BY A LEAK AT THE GASTROESOPHAGEAL JUNCTION. THE PHYSICIAN SUCCESSFULLY DRAINED THE ABSCESS. MESH HAD BEEN PLACED DURING THE INITIAL PROCEDURE, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. THE PATIENT WAS ADMITTED AND WAS DISCHARGED ON (B)(6) 2024 IN STABLE CONDITION.

  Patient problems: Abscess; Bacterial Infection; Chest Pain; Perforation of Esophagus

  MAUDE report 20258277 ↗
• MalfunctionAug 28, 2024Loss of or Failure to Bond; Mechanical Problem; Retraction Problem; Use of Device Problem; Loss of or Failure to Bond; Mechanical Problem; Retraction Problem; Use of Device Problem

  A PATIENT UNDERWENT A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. THROUGHOUT THE TIF PROCEDURE, THE PHYSICIAN REPORTED ISSUES WHEN DELIVERING FASTENERS FROM THE ESOPHYX DEVICE AND TROUBLESHOOTED THE PROBLEM. ONE STYLET WAS REPORTEDLY OUTSIDE OF THE GRAY MOLDING AND WOULD NOT RETRACT. THE ESOPHYX DEVICE WAS UNEVENTFULLY REMOVED FORM THE PATIENT. THERE IS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091463 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A PATIENT UNDERWENT A HIATIAL HERNIA REPAIR [HH] AND TRANSORAL INCISIONLESS FUNDOPLICATION [CTIF] PROCEDURE. A 60F BOUGIE WAS USED TO STREACH THE ESOPHAGUS PRIOR TO HH REPAIR. THE PATIENT RETURNED TO THE HOSPITAL ON AN UNKNOWN DATE DUE TO BACK PAIN AND A FEVER. FOLLOWING ADMITTANCE, THE PT RECEIVED AN EGD WITH NO NOTED ISSUES ON AN UNKNOWN DATE, AND CT SCAN WITH BARIUM SWALLOW ON AN UNKNOWN DATE. THE PT WAS SUBSEQUENTLY DIAGNOSED WITH A LEAK FROM AN UNKNOWN AREA WITH FLUID COLLECTION BEING DETECTED NEAR THE LIVER. THE PHYSICIAN ALLEGES THAT THERE IS NO EVIDENCE OF PERFORATION NEAR THE SITE OF THE TIF. (B)(6) 2023, THE PHYSICIAN PLACED A DRAIN FOR FLUID COLLECTION. THE CAUSE OF THE FLUID COLLECTION IS UNKNOWN. THE DEVICE WAS DISCARDED AT THE FACILITY WITH NO ADDITION PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Perforation

  MAUDE report 20082527 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT REPORTEDLY EXPERIENCED AN ADVERSE EVENT(S) FOLLOWING A HIATAL HERNIA REPAIR (HHR) AND TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE A PATIENT WAS ADMITTED FOR TWO ADDITIONAL DAYS FOR SURGICAL INTERVENTION TO CONTROL INTERNAL BLEEDING AND DEPLOYED HEMOSTATIC AGENTS FOR A NOTED HEMATOMA. THE PATIENT RECEIVED A BLOOD 1 UNIT OF BLOOD AND WAS CLOSELY MONITORED DURING RECOVERY. THE PATIENT WAS DISCHARGED 8 DAYS LATER WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20082526 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A MALE PATIENT UNDERWENT A TRANSORAL INCISIONLESS FUNDOPLICATION [TIF] PROCEDURE FOR GERD. THE PATIENT HAD A SEVERE COUGH, THAT WAS UNRELATED TO THE PROCEDURE WHEN DISCHARGED FROM THE HOSPITAL. THE PATIENT PRESENTED AGAIN 11 DAYS POST-TIF PROCEDURE FOR A GI PERFORATION ON THE ANTERIOR SIDE OF THE FASTENERS. IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE FASTENER FAILURES OR THE ALLEGED GI PERFORATION. THE CHEST TUBES WERE ALSO PLACED IN THIS PATIENT TO PREVENT IMPAIRMENT. THE DEVICE WAS NOT RETURNED FOR ENGINEERING OBSERVATION AND THERE ARE NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT. THE PATIENT TOLERATED THE PROCEDURES AND INTERVENTIONS WELL.

  Patient problems: Perforation of Esophagus; Pleural Empyema

  MAUDE report 20081883 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT UNDERWENT A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLUTATION [TIF] PROCEDURE AND WAS DISCHARGED TO HOME WITH NO PATIENT SYMPTOMS. THE PATIENT RETURNED TO THE HOSPITAL AT A LATER DATE AND WAS DIAGNOSED WITH ORTHOSTATIC HYPOTENSION. THE PATIENT'S HEMATOCRIT WAS ALSO LOW AFTER BLOOD TESTING. AN UPPER ENDOSCOPY WAS COMPLETED AND BLOOD WAS IDENTIFIED IN THE PATIENT'S STOMACH. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. NO INTERVENTIONS WERE DEEMED NECESSARY. APRIL 12, 2023, THE PATIENT WAS DOING FINE AND IS RECOVERING WELL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20052078 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  YOUTUBE VIDEO COMPLAINT WAS RECEIVED BY THE EGS TEAM. THE ACCOUNT ALLEGES THE PATIENT UNDERWENT A SUCCESSFUL HIATIAL HERNIA REPAIR [HHR] AND TRANSORAL INCISIONLESS FUNDOPLUTATION [TIF] PROCEDURE. AN UPPER ENDOSCOPY WAS COMPLETED AFTER THE PROCEDURE AND BLOOD WAS LEAKING INTO THE PATIENT'S STOMACH. THE PATIENT WAS ADMITTED TO ICU FOR CONTINUED OBSERVATION, AN ADDITIONAL INTERVENTIONAL PROCEDURE TO CONTROL THE BLEEDING WAS DEEMED NECESSARY. THE PATIENT ALSO NEEDED A BLOOD TRANSFUSION POST-INTERVENTION. ACCORDING TO THE VIDEO, THE PATIENT IS RECOVERING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20049394 ↗
• InjuryAug 22, 2024Fluid/Blood Leak; Mechanical Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Optical Obstruction; Fluid/Blood Leak; Mechanical Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Optical Obstruction

  A PATIENT UNDERWENT A HIATAL HERNIA REPAIR (HHR) PROCEDURE FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. AT LEAST ONE BOUGIE WAS USED PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE TO DILATE THE ESOPHAGUS. DURING THE TIF PROCEDURE, PER THE PHYSICIAN, THERE WAS DIFFICULTY DISENGAGING THE HELIX FROM TISSUE AT ONE PLACEMENT SITE. ONCE THE HELIX WAS DISENGAGED FROM THE TISSUE AT THE PLACEMENT SITE, SOME TISSUE WAS NOTED REMAINING IN THE HELIX COIL AND A BLEED, NOT REQUIRING TRANSFUSION WAS NOTED AT THE HELIX PLACEMENT SITE. THE PHYSICIAN ATTEMPTED TO CONTINUE THE PROCEDURE AND NOTED DIFFICULTY ENGAGING THE HELIX AT OTHER PLACEMENT SITES WITH THE NOTED TISSUE REMAINING IN THE COIL. ADDITIONALLY, THE PHYSICIAN NOTED IMPACTS TO VISIBILITY DUE TO THE BLEED AND DECIDED TO REMOVE THE ESOPHYX DEVICE. THE PHYSICIAN INSERTED AN ENDOSCOPE AND INJECTED EPINEPHRINE AT THE BLEEDING SITE. ADDITIONALLY, SEVEN HEMOSTATIC CLIPS WERE PLACED NEAR THE BLEEDING SITE, HOWEVER THE NOTED BLEEDING CONTINUED. PURA-STAT WAS APPLIED TO THE DISTAL ESOPHAGUS AT THE Z-LINE AND A COVERED ESOPHAGEAL STENT WAS PLACED IN THE DISTAL ESOPHAGUS. PER THE PHYSICIAN, THERE MAY HAVE BEEN MUSCULARIS TISSUE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20042259 ↗
• InjuryAug 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ACCOUNT ALLEGES THAT THE PATIENT UNDERWENT A SUCCESSFUL TRANSORAL INCISIONLESS FUND OPLUTATION [TIF] PROCEDURE. THE FOLLOWING DAY THE PATIENT PRESENTED WITH HYPOTENSIVE SYMPTOMS AND A DROP IN HEMOGLOBIN. AN ESOPHAGOGASTRODUODENOSCOPY [EGD] WAS PERFORMED DEMONSTRATING A GASTROESOPHAGEAL BLEED AT ONE OF THE PLACEMENT SITES OF THE HELICAL RETRACTOR WHICH WAS REPORTED TO BE REMOVED WITHOUT PROPER DISENGAGEMENT. THE PHYSICIAN PLACED MULTIPLE CLIPS AT THE PLACEMENT SITE AND WAS ABLE TO CONTROL THE PATIENT'S BLEEDING. THE BLEEDING DID NOT REQUIRE A BLOOD TRANSFUSION FOR THIS PATIENT. ON (B)(6) 2023 THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20012717 ↗