X-Tack Endoscopic HeliX Tacking SystemRecalls & reported problems across all models
Apollo Endosurgery, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 3 models of X-Tack Endoscopic HeliX Tacking System by Apollo Endosurgery, Inc. in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between May 18, 2021 and Aug 20, 2026 — classified as 15 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (7 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. 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
Reports received per month, all models
Most reported X-Tack Endoscopic HeliX Tacking System problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Activation Failure7
- Break4
- Material Deformation4
- Device-Device Incompatibility3
- Insufficient Device Problem Information3
- Activation, Positioning or Separation Problem2
- Difficult to Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Insufficient Information4
- Abdominal Pain3
- Hemorrhage/Blood Loss/Bleeding3
- Failure of Implant2
- Perforation2
- Wound Dehiscence2
X-Tack Endoscopic HeliX Tacking System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- X-Tack Endoscopic HeliX Tacking System XTACK-160-HEndoscopic Tissue Approximation Device22 reports
- X-Tack Endoscopic HeliX Tacking System CNH-C01-213-LHemostatic Metal Clip For The Gi Tract11 reports
- X-Tack Endoscopic HeliX Tacking System XTACK-235-HEndoscopic Tissue Approximation Device8 reports
Recent X-Tack Endoscopic HeliX Tacking System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351119 ↗InjuryJun 9, 2026Break; Failure to Cut; Activation Failure
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH - LONG WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH DID NOT CUT THE SUTURE OR DEPLOY, AND THE HANDLE BROKE. THE CINCH WAS MANUALLY DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25444836 ↗MalfunctionFeb 19, 2026Activation Failure
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE AND AFTER THE SUTURE WAS CUT, THE CINCH FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH A NEW SUTURE CINCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385524 ↗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 ↗MalfunctionJul 18, 2025Activation Failure; Activation Failure
IT WAS RETURNED TO BOSTON SCIENTIFIC THAT TWO SUTURING CINCH WAS USED IN A FISTULA CLOSURE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN FIRST USED ARGON TO CREATE A LESION SIMILAR TO AN ULCER AND THEN USED THE X-TACK DEVICE TO CLOSE THE LESION. THE X-TACK WORKED FINE, BUT WHEN THE PHYSICIAN USED THE SUTURING CINCH TO CUT THE SUTURE, THE CINCH DID NOT KNOT THE SUTURE, AND THE SUTURE CAME LOOSE FROM THE X-TACK. ADDITIONAL INFORMATION RECEIVED JUNE 23, 2025 CONFIRMED THE CINCH DID NOT PERFORM THE MECHANISM IT NORMALLY DOES TO PREVENT THE SUTURE FROM BECOMING LOOSE. THIS OCCURRED WITH TWO SUTURING CINCHES. THIS RECORD REPRESENTS THE FIRST OF TWO SUTURING CINCHES. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUTURING CINCH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22543698 ↗MalfunctionJul 18, 2025Activation Failure; Activation Failure
IT WAS RETURNED TO BOSTON SCIENTIFIC THAT TWO SUTURING CINCH WAS USED IN A FISTULA CLOSURE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN FIRST USED ARGON TO CREATE A LESION SIMILAR TO AN ULCER AND THEN USED THE X-TACK DEVICE TO CLOSE THE LESION. THE X-TACK WORKED FINE, BUT WHEN THE PHYSICIAN USED THE SUTURING CINCH TO CUT THE SUTURE, THE CINCH DID NOT KNOT THE SUTURE, AND THE SUTURE CAME LOOSE FROM THE X-TACK. ADDITIONAL INFORMATION RECEIVED JUNE 23, 2025, CONFIRMED THE CINCH DID NOT PERFORM THE MECHANISM IT NORMALLY DOES TO PREVENT THE SUTURE FROM BECOMING LOOSE. THIS OCCURRED WITH TWO SUTURING CINCHES. THIS RECORD REPRESENTS THE FIRST OF TWO SUTURING CINCHES. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUTURING CINCH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22543636 ↗MalfunctionJul 8, 2025Failure to Cut; Activation Failure; Failure to Cut; Activation Failure
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SUTURING CINCH WAS USED IN THE ESOPHAGUS DURING A FISTULA CLOSURE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE CINCH DID NOT RELEASE CORRECTLY AS IT DID NOT CUT THE THREAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUTURING CINCH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436303 ↗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 ↗MalfunctionApr 8, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SUTURING CINCH WAS USED IN AN ESD PROCEDURE ON (B)(6) 2025. WHEN DEPLOYING A SUTURING CINCH, THERE WAS A RESISTANCE, AND IT WAS IMPOSSIBLE TO USE THAT CINCH BECAUSE THE PHYSICIAN FELT RESISTANCE AND FINALLY BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. PROCEDURE COMPLETED WITH AN ALTERNATIVE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21796664 ↗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 ↗MalfunctionSep 9, 2024Positioning Failure; Material Deformation; Positioning Failure; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FIRST TACK WAS PLACED AND WHEN REMOVING CATHETER TO LOAD SECOND TACK, THE FIRST TACK PULLED OUT OF THE TISSUE. THE PHYSICIAN FELT TENSION WHEN REMOVING CATHETER AND THINKS THE SYSTEM WAS JAMMED UP OR TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20171464 ↗MalfunctionAug 22, 2024Device-Device Incompatibility; Difficult to Advance; Material Deformation; Device-Device Incompatibility; Difficult to Advance; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (235CM) WAS USED DURING AN EMR CLOSURE PROCEDURE PERFORMED ON (B)(6) 2024. AFTER DEPLOYMENT OF THE FIRST TACK DURING THE PROCEDURE, SIGNIFICANT RESISTANCE (TENSION ON SUTURE) WAS FELT COMING OUT OF THE COLONOSCOPE. WHEN THE SECOND TACK WAS LOADED AND ADVANCED THROUGH THE SCOPE, IT BECAME STUCK TO THE FIRST TACK. WHILE ATTEMPTING TO SEPARATE THE SECOND TACK, THE FIRST TACK DISLODGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER X-TACK DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20030749 ↗
Other Apollo Endosurgery, Inc. products
All Apollo Endosurgery, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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