X-Tack Endoscopic HeliX Tacking System CNH-C01-213-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10811955020756), received between Jan 14, 2022 and Aug 20, 2026 — classified as 2 injuries, 9 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, 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 11 most recent of 11 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 3, 2023Material Integrity Problem; Material Integrity Problem

  HEALTHCARE PROFESSIONAL REPORTED DURING LOADING OF THE SUTURE AND WHEN THE GOLD TAB WAS PULLED TO THREAD THE SUTURE, THE CINCH ALSO MOVED INTO THE CATHETER. DEVICE NOT ADMINISTERED TO THE PATIENT. THE CASE CONTINUED WITH A NEW CINCH. PATIENT WAS LATER ADMITTED TO ICU DUE TO A NON-DISCLOSED REASON HOWEVER UNRELATED TO THE DEVICE.

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

  MAUDE report 18068179 ↗
• MalfunctionAug 25, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  CINCH CUT THE SUTURE BUT DID NOT DISENGAGE FROM THE DEVICE. METAL WAS PULLED TO DISLODGE RESULTING IN REMOVAL OF THE SUTURES. PROCEDURE SUCCESSFULLY COMPLETED WITH COMPETITIVE DEVICE. PATIENT IS DOING WELL.

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

  MAUDE report 17622948 ↗
• MalfunctionMay 12, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  HEALTHCARE PROVIDER CINCH SUTURE BROKE DURING THE CINCHING PROCESS. PROCEDURE SUCCESSFULLY COMPLETED WITH COMPETITIVE DEVICE. PATIENT IS DOING WELL.

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

  MAUDE report 16918417 ↗
• MalfunctionJan 14, 2022Therapeutic or Diagnostic Output Failure

  APOLLO SUTURE CINCH- LONG FAILED UPON OPENING THE DEVICE - REP DISCOVERED UPON OPENING, IT WAS NOT USED ON THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257715 ↗