OverStitch Endoscopic Suturing System THX-165-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10811955020688), received between Jan 7, 2020 and Nov 11, 2025 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TISSUE HELIX WAS USED WITH OVERSTITCH DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE HELIX BECAME EMBEDDED IN TISSUE. THE PROCEDURE WAS COMPLETED BY USING A SNARE TO REMOVE THE HELIX. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519557 ↗
• InjuryOct 22, 2025Break; 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 OVERSTITCH ESS WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) CLOSURE PROCEDURE IN SIGMOID COLON ON (B)(6) 2025. DURING THE PROCEDURE, THE TISSUE HELIX BECAME STUCK IN THE PATIENT'S TISSUE. THE PHYSICIAN USED FORCEPS TO REMOVE THE HELIX. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360984 ↗
• InjuryJul 7, 2025Difficult to Remove; Difficult to Remove

  PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TISSUE HELIX WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. EVENT SUMMARY: DURING THE PROCEDURE, THE HELIX GOT SUCKED AND DISAPPEARED IN THE MUCOSA. TWO DAYS POST- PROCEDURE THE PATIENT PRESENTED ABDOMINAL PAIN. THE PATIENT WAS SCHEDULED FOR A FOLLOWED UP AND IT WAS DISCOVERED THAT THERE WAS A SMALL PERFORATION, THE PERFORATION WAS SUTURED. PATIENT STATUS: THERE WERE PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, SMALL PERFORATION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 22418756 ↗
• MalfunctionFeb 21, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TISSUE HELIX WAS USED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE TISSUE HELIX GOT STUCK IN TISSUE. THE PHYSICIAN TRIED ROTATION THE DEVICE COUNTERCLOCKWISE, CLOCKWISE, AND TENSION WITH THE ANCHOR EXCHANGE BUT THE DEVICE WOULD NOT RELEASE UNTIL EXCESS FORCE WAS USED TO REMOVE THE HELIX. 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 21437538 ↗
• MalfunctionAug 21, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TISSUE HELIX WAS USED DURING AN ESOPHAGEAL EXCISION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE THE HELIX WAS GETTING CAUGHT IN THE TISSUE AND WOULD NOT RETRACT, FORCE HAD TO BE APPLIED TO REMOVE FROM THE TISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE (CLIP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015512 ↗
• InjuryAug 13, 2024Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TISSUE HELIX WAS USED DURING AN ESOPHAGEAL SLEEVE GASTROPLASTY (ESG) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TISSUE HELIX COULD NOT BE FULLY REMOVED FROM THE TISSUE. THE PROCEDURE WAS RESCHEDULED TO EXTRACT THE REMAINING PART OF THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977393 ↗
• InjuryApr 18, 2024Difficult to Remove; Difficult to Remove

  THIS EVENT WAS PREVIOUSLY REPORTED BY APOLLO ENDOSURGERY. THE INITIAL (B)(6) 2023) AND SUPPLEMENTAL (B)(6) 2023 MEDWATCH REPORTS WERE SUBMITTED UNDER NUMBER 3006722112-2023-00077. APOLLO ENDOSURGERY WAS ACQUIRED BY BOSTON SCIENTIFIC CORPORATION (B)(6) 2023. HOWEVER, BOSTON SCIENTIFIC CORPORATION BEGAN PROCESSING COMPLAINTS FOR APOLLO ENDOSURGERY DEVICES ON (B)(6) 2023. ADDITIONAL INFORMATION REGARDING THE EVENT WAS RECEIVED ON (B)(6), 2024. IT WAS REPORTED TO APOLLO ENDOSURGERY / BOSTON SCIENTIFIC CORP. THAT THE TISSUE HELIX WAS UNABLE TO BE REMOVED FROM THE PATIENT RESULTING IN AN ABORTED PROCEDURE. THE EVENT REQUIRED ADDITIONAL ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES, HOSPITALIZATION, AND PROLONGED EPISODE OF CARE. THEREFORE, THIS HAS BEEN DEEMED A SERIOUS INJURY REPORTABLE EVENT. BOSTON SCIENTIFIC CORPORATION REVIEWED THIS INFORMATION ON (B)(6), 2024 AND DETERMINED THAT A CORRECTION REPORT NEEDED TO BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19137884 ↗
• MalfunctionAug 15, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  HEALTHCARE PROFESSIONAL REPORTED DIFFICULTY REMOVING HELIX FROM MUCOSA. ARGON USED FOR EVENTUAL REMOVAL AND CLIPS APPLIED FOR CLOSURE. PROCEDURE WAS ABORTED. PATIENT IS DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17549930 ↗
• MalfunctionMay 19, 2023Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  HELIX SCREWED INTO TISSUE THEN WOULD NOT UNSCREW FROM TISSUE. HELIX WAS REMOVED UTILIZING SMALL CUTS TO RELEASE FROM TISSUE. PROCEDURE WAS POSTPONED. PATIENT IS DOING FINE.

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

  MAUDE report 16961464 ↗
• MalfunctionApr 21, 2023Material Integrity Problem; Material Integrity Problem

  THE DEVICE GOT STUCK IN THE PATIENT AND WAS CUT TO BE REMOVED BUT PART OF THE DEVICE WAS STILL STUCK AND THE PATIENT HAD TO BE TRANSPORTED TO A NEW HOSPITAL WERE THE DOCTOR WAS ABLE TO REMOVE THE REST OF THE HELIX. THE PATIENT WAS RELEASED THE NEXT DAY AND IS DOING WELL.

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

  MAUDE report 16785648 ↗
• MalfunctionMar 8, 2022Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  HELIX PERFORATION IN STOMACH, WAS REMOVED SUCCESSFULLY.

  Patient problems: Perforation

  MAUDE report 13693434 ↗
• MalfunctionJun 23, 2021Mechanical Jam; Mechanical Jam

  DEVICE MALFUNCTIONED AND BECAME STUCK IN TISSUE CAUSING A SMALL PERFORATION.

  Patient problems: Perforation

  MAUDE report 12049930 ↗
• MalfunctionJun 14, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  DIFFICULTIES IN REMOVING THE HELIX FROM THE TISSUE CAUSING A SMALL HOLE IN THE STOMACH.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11995324 ↗
• InjuryJun 2, 2021Mechanical Jam; Mechanical Jam

  DEVICE MALFUNCTIONED WITH POSSIBLE PERFORATION OF THE STOMACH, PATIENT WAS ADMITTED FOR OBSERVATION.

  Patient problems: Insufficient Information; Perforation

  MAUDE report 11924737 ↗
• MalfunctionMay 11, 2021Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  DEVICE MALFUNCTIONED, CASE WAS COMPLETED SUCCESSFULLY WITH A COMPETITORS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806196 ↗
• InjuryDec 21, 2020Entrapment of Device; Difficult to Remove; Premature Separation; Entrapment of Device; Difficult to Remove; Premature Separation

  A CINCH CAME LOOSE FROM THE SUTURE PREMATURELY, THROUGH WHICH THE SEAM COULDN'T BE COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046350 ↗
• InjuryDec 21, 2020Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  THE TISSUE HELIX GOT STUCK IN THE TISSUE. THE PATIENT WAS TREATED SUCCESSFULLY AS A BACK-UP DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11046152 ↗
• MalfunctionNov 23, 2020Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  THE TISSUE HELIX GOT STUCK. IT WAS ULTIMATELY UNSCREWED AFTER A SIGNIFICANT AMOUNT OF EFFORT AND TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10886663 ↗
• InjuryNov 19, 2020Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  DIFFICULTIES IN REMOVING THE HELIX FROM THE TISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10871826 ↗
• MalfunctionJan 20, 2020Difficult to Remove; Difficult to Remove

  REPORTED AS: "THE DEVICE STAYS STUCK IN THE WALL OF THE PATIENT'S STOMACH. IMPOSSIBLE TO REMOVE. RISK OF TEAR."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9606964 ↗
• MalfunctionJan 7, 2020Difficult to Remove; Difficult to Remove

  COMPANY REPRESENTATIVE REPORTED ON BEHALF OF HEALTH PROFESSIONAL VIA FIELD COMMUNICATION FORM (FCF), "HELIX WAS STUCK IN PATIENT AND HAD TO BE FORCEFULLY REMOVED FROM THE PATIENT. SUTURE HAD TO BE CUT OUT OF PATIENT AS IT WOULDN'T TRANSFER TO ANCHOR EXCHANGE."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9558865 ↗