OverStitch Endoscopic Suturing System PLY-G02-020-APLRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00811955020735), received between Dec 28, 2020 and Sep 8, 2026 — classified as 3 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (47 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Material Twisted/Bent

  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, it was observed the anchor was bent. 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 50669444 ↗
• InjuryAug 13, 2026Break

  It was reported to Boston Scientific Corporation that an OverStitch 2-0 Polypropylene Suture was used during an Endoscopic Sleeve Gastroplasty (ESG) procedure performed on (b)(6) 2023.During emergent follow-up after the 2023 ESG procedure, the patient underwent an endoscopy to evaluate stomach pain. The endoscopy reportedly diagnosed erosive gastritis and identified excessive wires and plastic within the stomach. The patient reported that the implanted stitches appeared to have come undone; however, it was unknown whether the observed materials were contributing to the stomach irritation. The materials observed on gastroscopy were identified as overstitch/suture material following the primary procedure in (b)(6) 2023. The patient was treated with proton pump inhibitor therapy. The original ESG procedure was completed with the original devices, and no device issues were reported during the procedure. The patient remained clinically stable following the initial procedure and experienced an excellent initial recovery for the first 18 months post-procedure until the onset of abdominal pain.

  Patient problems: Erosion; Gastritis; Inflammation; Pain

  MAUDE report 50233692 ↗
• MalfunctionAug 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50127116 ↗
• MalfunctionJul 31, 2026Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094831 ↗
• MalfunctionJul 16, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25846211 ↗
• MalfunctionJul 14, 2026Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS INTENDED TO BE USED TO TREAT OBESITY DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, THERE WAS DIFFICULTY LOADING THE NEEDLE INTO THE NEEDLE HOLDER/NEEDLE SHAFT. MULTIPLE ATTEMPTS TO LOAD THE NEEDLE WERE UNSUCCESSFUL. VISUAL INSPECTION REVEALED AN APPARENT DEFORMED AREA AT THE PROXIMAL SECTION OF THE NEEDLE WHERE IT INTERFACES WITH THE NEEDLE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH 2-0 SUTURE OF THE SAME MODEL. THE PATIENT FULLY RECOVERED FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25821006 ↗
• MalfunctionJul 13, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25803718 ↗
• MalfunctionJul 13, 2026Break; Detachment of Device or Device Component

  It was reported to Boston Scientific that an OverStitch Suture was utilized during an Endoscopic Sleeve Gastroplasty (ESG) procedure on (b)(6) 2026 for the treatment of obesity. During the procedure, while pulling the suture before cinching, the thread broke and became detached from the needle shaft. Procedure was completed with another of the same device. No patient complications were reported as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25800962 ↗
• MalfunctionJul 10, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788524 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING A PANCREATIC FISTULA CLOSURE PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE BROKE AFTER IT WAS CONNECTED TO THE DEVICE. 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 24579005 ↗
• MalfunctionFeb 26, 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 COURSE OF THE PATIENT'S TREATMENT, THE PATIENT REPORTED A LOSS OF RESTRICTION AND A LACK OF WEIGHT LOSS. A FOLLOW UP ENDOSCOPY WAS CONDUCTED ON (B)(6) 2026. THE PHYSICIAN OBSERVED THAT THE SUTURES WERE NO LONGER PRESENT, INDICATING A SUTURE FAILURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462605 ↗
• MalfunctionDec 26, 2025Material Frayed; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Frayed; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON AN UNKNOWN DATE, AN OVERSTITCH SUTURE WAS USED DURING AN ESG PROCEDURE. AFTER LOADING THE SUTURE BUT BEFORE BEGINNING THE SUTURE SEQUENCE, THE PHYSICIAN NOTICED THAT THE SUTURE WAS SHREDDED. DURING THE DEVICE INVESTIGATION, THE SUTURE ANCHOR WAS IDENTIFIED AS BENT. THE SUTURE WAS REPLACED WITH A NEW SUTURE AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898106 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY 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 23865608 ↗
• MalfunctionDec 22, 2025Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO OVERSTITCH 2-0 POLYPROPYLENE SUTURE USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE SUTURE BROKE WHEN IT WAS TIME TO CINCH. THE SAME ISSUE HAPPENED WITH A SECOND SUTURE. 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 23862807 ↗
• MalfunctionDec 22, 2025Break; Break

  THIS REPORT PERTAINS TO THE SECOND OF TWO OVERSTITCH 2-0 POLYPROPYLENE SUTURES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE SUTURE BROKE WHEN IT WAS TIME TO CINCH. THE SAME ISSUE HAPPENED WITH A SECOND SUTURE. 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 23862798 ↗
• MalfunctionOct 9, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ESG PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, AFTER PLACING 11 SUTURES, THE ANCHOR WOULD NOT UNLOAD FROM THE NEEDLE BODY. THE SUTURE THEN SEPARATED FROM THE NEEDLE WHEN THE PHYSICIAN TRIED TO CINCH. AS A RESULT, THE SUTURE SEQUENCE HAD TO BE REPEATED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23253593 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING A STOMACH FISTULA CLOSURE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE SUTURE SNAPPED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL METHOD. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868452 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587010 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ONJ(B)(6) 2025 DURING THE PROCEDURE, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585570 ↗
• MalfunctionJul 1, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE SEVENTH BITE THE SUTURE BROKE WHEN PULLING THE SUTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370304 ↗
• MalfunctionMay 15, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY FOR COLONOSCOPY ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THE OVERSTITCH SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 22031131 ↗
• MalfunctionApr 10, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO EXCHANGE THE SUTURE FROM THE ANCHOR EXCHANGE TO THE NEEDLE DRIVER. IT WAS NOTICED THAT THE ANCHOR OF THE SUTURE WAS BENT, AND LATER THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21813297 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SUTURE CINCH WAS USED IN AN ESD PROCEDURE (B)(6) 2025. DURING THE PROCEDURE, THE ESOPHAGEAL STENT WAS PLACED IN THE ESOPHAGUS SUCCESSFULLY. MULTIPLE BITES WERE TAKEN WITH OVERSTITCH NXT AND THE T-TAG WAS DROPPED SO CINCHING COULD BE COMPLETED WITH THE SUTURING CINCH. THE TECHNICIAN LOADED THE SUTURE THROUGH THE SUTURE CINCH AND THE CINCH WAS PASSED DOWN THE SCOPE, OVER THE SUTURE. THE TECHNICIAN EXTENDED THE CINCH OUT UNTIL THE RINGS ON THE CATHETER WERE VISIBLE AND APPLIED MINIMAL PRESSURE TO THE SUTURE. THE TECHNICIAN WAS NOT ABLE TO DEPLOY THE CINCH. IT DID NOT CUT THE SUTURE AND DEPLOY NO MATTER HOW HARD THEY SQUEEZED. FINALLY, THEY "SNAPPED" THE CINCH AND WE USED THE APPROPRIATE BAILOUT TECHNIQUE WHERE THE CINCH'S HANDLE IS SNAPPED AND THEY MANUALLY PULL ON THE WIRE WITH A COKER OR INSTRUMENT. THIS DID NOT WORK EITHER EVEN WITH CONSIDERABLE PULLING ON THE WIRE. FINALLY, THE SUTURE ENDED UP GIVING WAY AND THE CINCH PULLED BACK INTO THE SCOPE AND WE WERE ABLE TO REMOVE THE SCOPE FROM THE PATIENT. UPON EXAMINATION, THE PEEK PLUG WAS STILL ATTACHED TO THE END OF THE CINCH AND WOULD NOT DETACH. THE PHYSICIAN OPTED TO NOT RESUTURE, BUT RAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573337 ↗
• MalfunctionMar 10, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO SECOND OF TWO OVERSTITCH SUTURE USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH SUTURE WAS USED IN AN ESG PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED (2) SUTURES BREAKING WITH LITTLE TO NO TENSION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561541 ↗
• MalfunctionMar 10, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH SUTURE WAS USED IN AN ESG PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED (2) SUTURES BREAKING WITH LITTLE TO NO TENSION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THIS REPORT PERTAINS TO THE FIRST OF TWO OVERSTITCH SUTURES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561539 ↗