OverStitch Endoscopic Suturing System CNH-G01-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10811955020671), received between May 25, 2020 and Sep 21, 2026 — classified as 15 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (24 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845864 ↗
• InjurySep 21, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845081 ↗
• InjurySep 21, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844809 ↗
• InjuryJul 27, 2026Activation Failure

  It was reported to Boston Scientific Corporation that an OverStitch Suture Cinch was used during a stent fixation procedure performed in the stomach on (b)(6)2026. During the procedure, the cinch failed to deploy. The procedure was completed when the physician manually deployed the cinch. There was no patient complications reported as a result of this event.This is the second of two Suturing Cinches used in the same procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50003185 ↗
• InjuryJul 27, 2026Activation Failure

  It was reported to Boston Scientific Corporation that an OverStitch Suture Cinch was used during a stent fixation procedure on (b)(6) 2026. During the procedure, the cinch failed to deploy. The procedure was completed when the physician manually deployed the cinch. There was no patient complications reported as a result of this event.Note: This is the first of two Suturing Cinches used in the same procedure.***Additional Information received on 04 AUG 2026***The patient anatomy was the stomach and the indication for the procedure was prosthesis fixation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50003178 ↗
• MalfunctionJul 17, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25856048 ↗
• InjuryJun 29, 2026Mechanical Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH AND X-TACK DEVICE WERE UTILIZED DURING A DEFECT CLOSURE PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN USED AN X-TACK DEVICE TO CLOSE THE DEFECT, SUCCESSFULLY APPROXIMATING ALL EDGES OF THE HEALTHY TISSUE. THE SUTURE CINCH WAS SUBSEQUENTLY UTILIZED; HOWEVER, DURING CINCH DEPLOYMENT, THE SUTURE CINCH MALFUNCTIONED AND SEVERED THE SUTURES WHILE BEING TIGHTENED. AS A RESULT, ALL X-TACK SUTURES BROKE, CAUSING THE TACKS TO DISENGAGE FROM THE TISSUE. CONSEQUENTLY, THE X-TACK CLOSURE WAS LOST DUE TO THE SUTURE CINCH MALFUNCTION. THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AND WAS ADMITTED TO THE HOSPITAL BEYOND THE EXPECTED STANDARD OF CARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT DEVICE OF THE SAME TYPE.

  Patient problems: Discomfort; Pain

  MAUDE report 25650403 ↗
• MalfunctionJun 17, 2026Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6), 2026. DURING THE PROCEDURE, THE CINCH CUT THE SUTURE BUT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE CINCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541355 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING A PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW CINCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968319 ↗
• MalfunctionFeb 26, 2026Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH FAILED TO DEPLOY AND THE STITCH WAS LOST. THE PROCEDURE WAS PROLONGED BY AN UNKNOWN AMOUNT OF TIME. THE PROCEDURE WAS COMPLETED WITH A NEW SUTURING CINCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454984 ↗
• MalfunctionFeb 13, 2026Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH WAS STUCK INSIDE OF THE PATIENT. 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 24332308 ↗
• MalfunctionJan 6, 2026Break; Failure to Cut; Activation Failure

  THIS REPORT PERTAINS TO THE FIRST OF TWO OVERSTITCH SUTURE CINCHES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF OBESITY. DURING THE PROCEDURE, THE OVERSTITCH SUTURE CINCH WAS UNABLE TO CUT THE SUTURE AND THE CINCH HANDLE BECAME JAMMED. THE CINCH WIRE SUBSEQUENTLY BROKE, AND THE OVERSTITCH SUTURE CINCH FAILED TO DEPLOY. A SECOND OVERSTITCH SUTURE CINCH WAS THEN ATTEMPTED; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO DEPLOY AND CUT THE SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME MODEL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971447 ↗
• MalfunctionJan 6, 2026Failure to Cut; Activation Failure

  THIS REPORT PERTAINS TO THE SECOND OF TWO OVERSTITCH SUTURE CINCHES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF OBESITY. DURING THE PROCEDURE, THE OVERSTITCH SUTURE CINCH WAS UNABLE TO CUT THE SUTURE AND THE CINCH HANDLE BECAME JAMMED. THE CINCH WIRE SUBSEQUENTLY BROKE, AND THE OVERSTITCH SUTURE CINCH FAILED TO DEPLOY. A SECOND OVERSTITCH SUTURE CINCH WAS THEN ATTEMPTED; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO DEPLOY AND CUT THE SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME MODEL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971444 ↗
• MalfunctionDec 22, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE CINCH FAILED TO CUT THE SUTURE. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH SUTURE CINCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865129 ↗
• MalfunctionDec 22, 2025Activation Failure; Activation Failure

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO OVERSTITCH SUTURE CINCH DEVICE USED DURING THE SAME PROCEDURE IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE CINCH FAILED TO DEPLOY. THE SAME ISSUE OCCURRED WITH A SECOND SUTURE CINCH DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 23863271 ↗
• MalfunctionDec 22, 2025Activation Failure; Activation Failure

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO OVERSTITCH SUTURE CINCH DEVICE USED DURING THE SAME PROCEDURE IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE CINCH FAILED TO DEPLOY. THE SAME ISSUE OCCURRED WITH A SECOND SUTURE CINCH DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 23863096 ↗
• MalfunctionNov 7, 2025Material Integrity Problem; Activation Failure; Material Integrity Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ESG PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE CINCH PLUG WAS BENT AND THEREFORE COULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH A NEW CINCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495938 ↗
• MalfunctionOct 2, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK DEVICE WAS USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE CINCH FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203059 ↗
• MalfunctionOct 2, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK DEVICE WAS USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE CINCH FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH A NEW X-TACK DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203054 ↗
• MalfunctionOct 2, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN X-TACK DEVICE WAS USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE CINCH FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203041 ↗
• MalfunctionSep 2, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE WHILE ATTEMPTING TO CINCH THE SUTURE, THE CINCH WAS RELEASED BUT THE SUTURE WAS NOT CUT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931778 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE CINCH, THE SUTURE WAS CUT BUT THE CINCH REMAINED ATTACHED TO THE WIRE AND HANDLE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE USING FORCEPS TO SEPARATE THE CINCH FROM THE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543723 ↗
• MalfunctionJun 18, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING AN ENDOSCOPIC PROCEDURE IN THE ESOPHAGUS, ON AN UNKNOWN DATE. THE SUTURING CINCH FAILED TO CUT THE SUTURE, AND THE SUTURE THREAD WAS ATTACHED AT THE SITE OF THE ESOPHAGEAL STITCH AND CAME OUT OF THE PATIENTS MOUTH UNCUT. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285711 ↗
• MalfunctionJun 10, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPPER GI PAN ENDOSCOPY WAS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE OVERSTITCH SUTURE CINCH COULD NOT BE CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO TWO OF TWO OVERSTITCH SUTURE CINCH USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177946 ↗
• MalfunctionJun 10, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPPER GI PAN ENDOSCOPY WAS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE OVERSTITCH SUTURE CINCH COULD NOT BE CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO ONE OF TWO OVERSTITCH SUTURE CINCH USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176673 ↗