OverStitch™ M00505450Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00191506049126), received between Sep 9, 2025 and Aug 28, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488966 ↗
• MalfunctionAug 24, 2026Break

  It was reported to Boston Scientific Corporation that an Overstitch Suture was used during an Endoscopic Sleeve Gastroplasty (ESG) procedure on (b)(6) 2026. During the procedure, the suture broke. The procedure was completed with a new Overstitch Suture. There was no patient complications reported as a result of this event.This is the third of three Overstitch Sutures used in the same procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50401756 ↗
• MalfunctionAug 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351138 ↗
• MalfunctionAug 18, 2026Break

  It was reported to Boston Scientific Corporation that an Overstitch Suture was used during an Endoscopic Sleeve Gastroplasty (ESG) procedure on (b)(6) 2026. During the procedure, the suture broke. The procedure was completed with a new Overstitch Suture. There was no patient complications reported as a result of this event.This is the second of three Overstitch Sutures used in the same procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308206 ↗
• MalfunctionAug 18, 2026Break

  It was reported to Boston Scientific Corporation that an Overstitch Suture was used during an Endoscopic Sleeve Gastroplasty (ESG) procedure on (b)(6) 2026. During the procedure, the suture broke. The procedure was completed with a new Overstitch Suture. There was no patient complications reported as a result of this event.This is the first of three Overstitch Sutures used in the same procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308198 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287289 ↗
• MalfunctionAug 17, 2026Break

  It was reported to Boston Scientific Corporation that an OverStitch 2-0 Polypropylene Suture was used to treat obesity during an Endoscopic sleeve gastroplasty procedure performed on (b)(6) 2026.During the procedure, the device exhibited a condition where the suture snapped when removing slack. The procedure was completed with another device of the same model.The patient is stable following the procedure, and there were no problems reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287282 ↗
• MalfunctionJun 30, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, DURING CINCHING THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS IS THE FIRST OF TWO OVERSTITCH SUTURES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673514 ↗
• MalfunctionJun 22, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE WHERE THE SUTURE CONNECTS TO THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS IS THE FIRST OF TWO OVERSTITCH SUTURES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580188 ↗
• MalfunctionJun 16, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN WAS PLACING A U-STITCH SUTURE PATTERN WHEN TWO SUTURES BROKE IN THE MIDDLE OF THE SUTURE MATERIAL RATHER THAN DETACHING FROM THE ANCHOR. THE FIRST AFFECTED SUTURE WAS REMOVED FROM USE AND REPLACED WITH A NEW DEVICE; HOWEVER, THE ISSUE RECURRED WITH A SECOND SUTURE, REQUIRING ANOTHER REPLACEMENT DEVICE TO BE OPENED. APPROXIMATELY 10 MINUTES WERE REQUIRED EACH TIME TO CUT AND REMOVE THE BROKEN SUTURE, RESULTING IN AN ESTIMATED 20-MINUTE PROCEDURE PROLONGATION. THE PROCEDURE WAS ULTIMATELY COMPLETED USING ANOTHER OF THE SAME DEVICE FROM A DIFFERENT LOT. DURING THE PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA LOCATED IN THE BODY OF THE STOMACH BETWEEN THE GREATER AND LESSER CURVATURE. NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE HEMATOMA; THE PHYSICIAN SUTURED AROUND THE AFFECTED AREA AND COMPLETED THE PROCEDURE. THE PHYSICIAN WAS UNABLE TO DETERMINE WHETHER THE DEVICE OR THE PROCEDURE CAUSED OR CONTRIBUTED TO THE HEMATOMA. THE PATIENT WAS NOT ADMITTED BEYOND THE STANDARD O

  Patient problems: Hematoma

  MAUDE report 25524911 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE. 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 25334429 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED DURING A PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE. 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 25191500 ↗
• MalfunctionApr 22, 2026Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. THE ANCHOR WAS BENT. INFORMATION REGARDING THE OUTCOME OF THE PROCEDURE WAS NOT PROVIDED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951085 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE. THE PHYSICIAN ATTEMPTED TO USE THREE ADDITIONAL SUTURES, WHICH ALSO BROKE. THE PROCEDURE WAS COMPLETED WITH CLIPS. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS IS THE SECOND OF FOUR OVERSTITCH SUTURES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793881 ↗
• MalfunctionApr 6, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE. THE PHYSICIAN ATTEMPTED TO USE THREE ADDITIONAL SUTURES, WHICH ALSO BROKE. THE PROCEDURE WAS COMPLETED WITH CLIPS. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS IS THE FOURTH OF FOUR OVERSTITCH SUTURES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793879 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE. THE PHYSICIAN ATTEMPTED TO USE THREE ADDITIONAL SUTURES, WHICH ALSO BROKE. THE PROCEDURE WAS COMPLETED WITH CLIPS. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS IS THE THIRD OF FOUR OVERSTITCH SUTURES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793876 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE. THE PHYSICIAN ATTEMPTED TO USE THREE ADDITIONAL SUTURES, WHICH ALSO BROKE. THE PROCEDURE WAS COMPLETED WITH CLIPS. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS IS THE FIRST OF FOUR OVERSTITCH SUTURES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793874 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696958 ↗
• MalfunctionFeb 12, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326272 ↗
• MalfunctionFeb 10, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE AND DETACHED FROM THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302807 ↗
• MalfunctionJan 13, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, AN UNDETERMINED NUMBER OF SUTURES WERE REPORTED TO HAVE SNAPPED; HOWEVER, THE EXACT NUMBER COULD NOT BE CONFIRMED. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. DETAILED INFORMATION REGARDING THE TOTAL NUMBER OF SUTURES WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF TWO REPORTS BEING SUBMITTED TO COVER THE SUTURE THAT LOOKED FRAYED AND THE OTHER SUTURES THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055274 ↗
• MalfunctionJan 12, 2026Break; Material Frayed; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. PRIOR TO THE PROCEDURE, ONE SUTURE LOOKED FRAYED. DURING THE PROCEDURE, THE SUTURE SNAPPED AND DETACHED FROM THE DEVICE AND BROKE. ACCORDING TO THE INFORMATION PROVIDED ADDITIONAL SUTURES WERE USED, HOWEVER THEY BROKE TOO. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. DETAILED INFORMATION REGARDING THE TOTAL NUMBER OF SUTURES WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF TWO REPORTS BEING SUBMITTED TO COVER THE SUTURE THAT LOOKED FRAYED AND THE OTHER SUTURES THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049129 ↗
• MalfunctionJan 6, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971884 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED DURING A TORE (TRANSORAL OUTLET REDUCTION)/RAP (RESECTION AND PLICATION) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE SUTURE BROKE WHEN IT WAS LOADED ONTO THE ANCHOR EXCHANGE CATHETER AFTER 5 SUTURE BITES. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971703 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6), 2025. DURING THE PROCEDURE, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED USING APOLLO BRANDED SUTURES. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000142 ↗