X-Tack Endoscopic HeliX Tacking System XTACK-235-HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10811955020770), received between May 18, 2021 and Sep 9, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJul 9, 2024Use of Device Problem; Device-Device Incompatibility; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Device-Device Incompatibility; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK WAS USED DURING AN EMR PROCEDURE PERFORMED ON (B/)(6) 2024. DURING PREPARATION OF THE DEVICE PHYSICIAN CUT AND REMOVED THE SCOPE LINER FUNNEL. WHILE ADVANCING THE 4TH X-TACK THROUGH THE SCOPE, A PIECE OF COILED PLASTIC FROM THE SCOPE APPEARED WHEN THE TACK CAME OUT OF THE DISTAL END OF THE SCOPE. ALL COILED PLASTIC PIECES WERE REMOVED WITH BIOPSY FORCEPS AND RAT TOOTH FORCEPS. THE 4TH TACK WAS REMOVED, AND THE 3 INITIAL X-TACKS WERE CINCHED. THE PROCEDURE WAS COMPLETED USING CLIPS. ALTERING OF THE DEVICE, CUTTING THE SCOPE LINER FUNNEL, ALLOWED DAMAGE TO THE WORKING CHANNEL OF THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702368 ↗
• MalfunctionMay 7, 2024Break; Difficult to Remove; Activation, Positioning or Separation Problem; Break; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A X-TACK ENDOSCOPIC HELIX TACKING SYSTEM WAS USED DURING A FISTULA CLOSURE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE X-TACK WAS DIFFICULT TO RELEASE FROM THE CATHETER. DURING DEPLOYMENT, THE X-TACK HANDLE BROKE CAUSING DIFFICULTY IN REMOVING THE X-TACK CATHETER. THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258915 ↗
• MalfunctionMar 20, 2024Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK ENDOSCOPE HELIX TACKING SYSTEM (235CM) WAS USED DURING A COLON HEMOSTASIS PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE X-TACK "PRESENTED A DEFECT" WHEN REMOVING THE CATHETER FROM THE WORKING CHANNEL, PULLING THE WIRE. THE PROCEDURE WAS NOT COMPLETED. THERE WERE 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 18940566 ↗
• 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 A X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (235CM) WAS USED DURING A MUCOSAL DEFECT CLOSURE IN THE TRANSVERSE COLON PERFORMED ON (B)(6) 2022. THE PROCEDURE WAS COMPLETED BUT WAS NOT CONSIDERED A TECHNICAL SUCCESS. THE FISTULA HAD IMPROVED APPEARANCE BUT WAS NOT COMPLETELY SEALED. THE PATIENT WAS HOSPITALIZED WITH NO ICU STAY AND WAS DISCHARGED ON (B)(6) 2022. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18270997 ↗
• MalfunctionNov 22, 2021Activation, Positioning or Separation Problem

  ATTEMPTED TO CLOSE DEFECT FROM EMR (ENDOSCOPIC MUCOSAL RESECTION) WITH APOLLO X-TACK SUTURE SYSTEM. DEVICE WOULD NOT DEPLOY PROPERLY. PROVIDER WAS ABLE TO IMPLANT ONE HELIX, BUT UNABLE TO REMOVE THE CATHETER WITHOUT PULLING HELIX OUT OF TISSUE. CALLED VENDOR REP FOR ASSISTANCE, AND WATCHED VIDEOS OF DEVICE. STILL UNABLE TO GET DEVICE TO WORK PROPERLY. FINISHED PROCEDURE WITHOUT CLOSING DEFECT.

  Patient problems: Insufficient Information

  MAUDE report 12851324 ↗
• MalfunctionMay 18, 2021Mechanical Problem; Mechanical Problem

  DEVICE MALFUNCTIONED AND USED A COMPETITORS DEVICE TO COMPLETE THE CASE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845227 ↗