X-Tack Endoscopic HeliX Tacking System XTACK-160-HRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10811955020763), received between Feb 14, 2023 and Aug 12, 2025 — classified as 11 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SITE CLOSURE ON (B)(6) 2025. AFTER REMOVING THE DEVICE FROM THE PACKAGE, THE SUTURE BECAME KNOTTED AND WAS NOT ABLE TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE FROM THE SAME MODEL. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784009 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN X-TACK WAS USED IN THE STOMACH FOR TREATMENT OF A GASTRIC ULCER IN THE INCISURA DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH CLOSURE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ENDOSCOPE WAS PASSED INTO THE STOMACH TO CLOSE A GASTRIC ULCER IN THE STOMACH INCISURA. FOUR HELIX TACKS WERE PLACED. WHEN THE PHYSICIAN PULLED THE SUTURE TO APPROXIMATE THE DEFECT, THE SUTURE WAS CAUGHT IN THE SYSTEM AND COULD NOT BE PULLED TO APPROXIMATE THE DEFECT. THE SUTURE WAS CUT AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER X-TACK. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22348865 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM) WAS USED DURING AN UNKNOWN PROCEDURE TYPE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE X-TACK ENDOSCOPIC HELIX TACKING SYSTEM SYSTEM PERFORMANCE WAS DISSATISFACTORY IN RELATION TO CLOSURE. THE PHYSICIAN ADVISED THAT HE HAD EXPERIENCED TWO SERIOUS POST COMPLICATIONS OF LEAKS AFTER CLOSURE WITH X-TACK. NO INFORMATION HAS BEEN PROVIDED TO DATE ON HOW THE LEAKS WERE TREATED OR IF THEY WERE TREATED.

  Patient problems: Wound Dehiscence

  MAUDE report 21503678 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM) WAS USED DURING AN UNKNOWN PROCEDURE TYPE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE X-TACK ENDOSCOPIC HELIX TACKING SYSTEM PERFORMANCE WAS DISSATISFACTORY IN RELATION TO CLOSURE. THE PHYSICIAN ADVISED THAT HE HAD EXPERIENCED TWO SERIOUS POST COMPLICATIONS OF LEAKS AFTER CLOSURE WITH X-TACK. NO INFORMATION HAS BEEN PROVIDED TO DATE ON DESPITE GOOD FAITH EFFORTS.

  Patient problems: Wound Dehiscence

  MAUDE report 21503522 ↗
• InjuryOct 29, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM) WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) FOR A FISTULA CLOSURE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE X-TACK SYSTEM BROKE THE SUTURE. THE PHYSICIAN AT THIS POINT DECIDED IT WAS BEST FOR THE PATIENT, TO JUST LET THE FISTULA HEAL ON ITS OWN. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561230 ↗
• MalfunctionOct 29, 2024Difficult or Delayed Positioning; Device-Device Incompatibility; Difficult or Delayed Positioning; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM) WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) FOR A FISTULA CLOSURE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE X-TACK SYSTEM BROKE THE SUTURE. THE PHYSICIAN AT THIS POINT DECIDED IT WAS BEST FOR THE PATIENT, TO JUST LET THE FISTULA HEAL ON ITS OWN. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559647 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM WAS USED DURING AN ESD PERFORMED ON (B)(6) 2024. A PERFORATION WAS IDENTIFIED POST PROCEDURE. THE PHYSICIAN DETERMINED THE PERFORATION WAS CAUSED BY THE ESD PROCEDURE AND NOT THE USE OF THE X-TACK DEVICE. A LAPAROSCOPY WAS PERFORMED TO RESOLVE THE PERFORATION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE AND WELL.

  Patient problems: Perforation

  MAUDE report 19498262 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM) WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE OF THE STOMACH ON (B)(6),2022. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED FOR OVERNIGHT OBSERVATION. THE PATIENT WAS DISCHARGED ON (B)(6), 2022. MEDICATION WAS PRESCRIBED AND AN ADDITIONAL ENDOSCOPIC PROCEDURE WAS PERFORMED ON (B)(6), 2023. THERE WERE NO OTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Abdominal Pain

  MAUDE report 18323056 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM) WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE FOR A FISTULA OF THE STOMACH ON (B)(6) 2022. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED NAUSEA AND VOMITING. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND MEDICATION WAS PRESCRIBED. THERE WERE NO OTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Nausea; Vomiting

  MAUDE report 18314231 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORTATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM WAS USED TO CLOSE A MUCOSAL DEFECT IN THE ASCENDING COLON ON (B)(6) 2023. THE PROCEDURE WAS DEEMED A TECHNICAL SUCCESS, AND THE PATIENT WAS DISCHARGED HOME WITH NO RESTRICTION THE DAY OF (B)(6) 2023. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2023 WITH RIGHT LOWER QUADRANT ABDOMINAL PAIN. A CT WAS PREFORMED WHERE IT SHOWED PNEUMOPERITONEUM CONCERNING PERFORATION. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WHERE PERFORATION WAS NOTED IN THE ASCENDING COLON. DURING THE EXPLORATORY LAPAROSCOPIC PROCEDURE, RIGHT HEMICOLECTOMY WITH ANASTOMOSIS WAS PERFORMED WITH CHOLECYSTECTOMY FOR INFLAMED GALLBLADDER, SUBCUTANEOUS WOUND VAC WAS APPLIED TO THE SKIN. ON (B)(6) 2023, THE PATIENT UNDERWENT WALL IRRIGATION AND DEBRIDEMENT WITH WOUND VAC PLACEMENT. ON (B)(6) 2023, THE PATIENT UNDERWENT ABDOMINAL WOUND CLOSURE WITH STAPLES AND INCISIONAL WOUND VAC.

  Patient problems: Abdominal Pain; Inflammation; Perforation; Unspecified Infection

  MAUDE report 18290455 ↗
• MalfunctionDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT WAS REPORT FROM A CLINICAL STUDY. ON THE FOLLOW UP VISIT THE PATIENT PRESENTED WITH BLEEDING. PATIENT WAS ADMITTED TO THE HOSPITAL WHERE SHE WAS HAD AND ENDOSCOPY PERFORMED AND IT WAS FOUND PATIENT WAS BLEEDING. THE PATIENT WAS GIVING MEDICATION AND BLOOD TRANSFUSION. SHE WAS DISCHARGED 4 DAYS AFTER BEING ADMITTED WITH NO CONCERNS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18284979 ↗
• MalfunctionDec 7, 2023Separation Problem; Premature Separation; Separation Problem; Premature Separation

  PREMATURE OF TRACK NOT USED. INADEQUATE ANCHORING OF X-TACK CONSTRUCTS. OVESCO 11/6T, 1 CLIP(COMPETITORS DEVICE) USED IN THE CASE TO CLOSE THE PERFORATION OF THE ESOPHAGUS. MUCOSAL DEFECT CLOSURE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18283636 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM WAS USED IN THE ESOPHAGUS ON (B)(6) ,2022 DURING A STENT FIXATION PROCEDURE FOR ESOPHAGEAL STRICTURE. AFTER THE INITIAL PROCEDURE, THE PATIENT EXPERIENCED EPIGASTRIC PAIN REQUIRING MEDICATION. ON JUNE 1, 2022 IT WAS DETERMINED THAT THE STENT MIGRATED. A FOLLOW UP ENDOSCOPY PROCEDURE WAS PERFORMED ON (B)(6), 2022. THE PATIENT WAS DISCHARGED TO HOME WITH NO RESTRICTIONS. NOTE: THERE IS NO ALLEGATION AGAINST THE X-TACK ENDOSCOPIC HELIX TACKING SYSTEM AND TO NOTE THE STENT WAS NOT MANUFACTURED BY BOSTON SCIENTIFIC.

  Patient problems: Pain

  MAUDE report 18275295 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM WAS USED ON (B)(6) 2021, FOR A MUCOSAL DEFECT CLOSURE PROCEDURE. THE PROCEDURE WAS DEEMED A TECHNICAL SUCCESS. THE PATIENT WAS DISCHARGED THE SAME DAY WITH NO RESTRICTIONS. A FOLLOW UP ENDOSCOPY PROCEDURE WAS PERFORMED ON (B)(6) 2022, WHERE IT IS NOTED THAT BLEEDING HAD REOCCURRED; THEY PROCEEDED WITH A SNARE POLYPECTOMY AND USED A MANTIS CLIP DURING THE PROCEDURE. NOTED: THE X-TACK ENDOSCOPIC HELIX TACKING SYSTEME DID NOT CONTRIBUTE TO THE BLEEDING. ADDITIONAL INFORMATION THE FOLLOW UP ENDOSCOPY PROCEDURE WAS PERFORMED DUE TO THE POLYP RECURRED, THE POLYP WAS REMOVED WITH A SNARE AND THE TREATMENT WAS NOT IMPACTED BY XTACK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18274588 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM WAS USED DURING A POLYPECTOMY WITH MUCOSAL DEFECT CLOSURE PERFORMED IN THE STOMACH ON (B)(6) 2022. AFTER THE PROCEDURE, THE PATIENT HAD MILD CHEST DISCOMFORT. THE PATIENT WAS GIVEN MEDICATION, STAYED FOR OVERNIGHT OBSERVATION, AND WAS DISCHARGED ON (B)(6) 2022. IT WAS REPORTED THAT THE CHEST DISCOMFORT WAS NOT RELATED TO THE X-TACK ENDOSCOPIC HELIX TACKING SYSTEM, AND THE EVENT WAS RESOLVED.

  Patient problems: Chest Pain

  MAUDE report 18270904 ↗
• InjuryNov 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  HEALTHCARE PROFESSIONAL REPORTED X-TACK DEVICE FAILUED POST PROCEDURE. PATIENT ADMITTED TO THE HOSPITAL TO REPAIR DEFECT LEAK AS WELL AS TREAT DEVELOPED MEDIASTINIS, SEPSIS, PLEURAL EFFUSION, PNEUMONIA AND ATELECTASIS.

  Patient problems: Failure of Implant; Pneumonia; Sepsis

  MAUDE report 18055501 ↗
• MalfunctionOct 23, 2023Mechanical Problem; Mechanical Problem

  REPORTED - THE PATIENT WAS BLEEDING WHICH REQUIRED HOSPITAL STAY AND WAS ADMITTED TO THE ICU. IT WAS REPORTED THAT THE PATIENT STOPPED TAKEN HIS MEDICIATION THE DAY PRIOR TO THE ORIGINAL PROCEDURE. THE EVENT HAPPED DAYS AFTER THE ORIGINAL PROCEDURE WITH NO ISSUES DURING THE ENDOSCOPY.THE PATIENT IS DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia

  MAUDE report 17987558 ↗
• MalfunctionSep 8, 2023Premature Separation; Premature Separation

  HEALTHCARE PROFESSIONAL REPORTS TWO SUTURES FELL APART UPON CINCHING. PROCEDURE SUCCESSFULLY COMPLETED WITH COMPETITIVE DEVICE. PATIENT IS DOING WELL. OF THE TWO DEVICES REPORTED, ONLY ONE WAS RETURNED FOR ANALYSIS FOR WHICH THE LOT NUMBER COULD NOT BE IDENTIFIED.

  Patient problems: Failure of Implant

  MAUDE report 17714385 ↗
• MalfunctionJun 5, 2023Difficult to Fold, Unfold or Collapse; Unintended Collision; Difficult to Fold, Unfold or Collapse; Unintended Collision

  SUTURE BECAME ENTANGLED WITHIN THE ENDOSCOPE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITIVE DEVICE. THE PATIENT IS DOING WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17059738 ↗
• MalfunctionMay 15, 2023Material Perforation; Migration; Material Perforation; Migration

  THIS COMPLAINT WAS FOUND DURING A LITERATURE REVIEW: ONE MONTH AFTER HAVING A CECAL SESSILE POLYP REMOVAL. THE PATIENT PRESENTED DIFFUSE ABDOMINAL PAIN AND ABDOMINAL DISTENSION, A CT SCAN WAS PERFORMED AND IT WAS FOUND THAT THE OBSTRUCTION OF THE SMALL INTESTINE. A BOWEL RESECTION WAS PERFORMED AND THE PATIENT IS DOING WELL.

  Patient problems: Abdominal Pain; Bowel Perforation; Perforation of Vessels

  MAUDE report 16929654 ↗
• MalfunctionMay 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT WAS FIUND DURING A LITERATURE REVIEW. THERE WAS ONE CASE REPORT FOR PERFORATION WHICH REQUIRED SURGICAL INTERVENTION WITH FULL RECOVERY.

  Patient problems: Perforation of Esophagus

  MAUDE report 16918420 ↗
• MalfunctionFeb 14, 2023Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  AFTER DEPLOYING 1ST SUTURE THE NEXT SUTURE APPEARED NOT TO DEPLOY, ONCE THE EQUIPMENT WAS REMOVED IT WAS DISCOVERED THAT THE TACK WAS STUCK IN THE PLASTIC CATHETER. SURGERY WAS COMPLETED WITH A COMPETITOR'S DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16373086 ↗