OverStitch NXT Endoscopic Suturing System ESS-ESG-NXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811955020834), received between Jul 11, 2025 and Oct 27, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN EDG PROCEDURE ON OCTOBER 1, 2025. DURING THE PROCEDURE, THE PHYSICIAN PREPARED TO PLACE A SECOND SUTURE. TOO MUCH TISSUE WAS CAPTURED BY THE DEVICE AND THE ANCHOR EXCHANGE FAILED TO UNLOAD FROM THE NEEDLE BODY. WITH THE ANCHOR STILL IN THE PATIENT'S TISSUE, THE PHYSICIAN USED SCISSORS TO CUT THE SUTURE AND LEFT THE ANCHOR IN THE ESOPHAGEAL WALL. THE PROCEDURE WAS COMPLETED WITH MANTIS CLIPS TO FIXATE THE STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389928 ↗
• MalfunctionSep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE AND AFTER THE FIRST SUTURE WAS COMPLETED, THE OVERSTITCH NXT TOWER SLID FORWARD AND WAS NO LONGER TOUCHING THE DISTAL END OF THE SCOPE. A NEW OVERSTITCH NXT WAS USED 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 22954211 ↗
• InjuryAug 22, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING A STENT SUTURING PROCEDURE ON (B)(6) 2025. DURING INSERTION, THE OVERSTITCH DEVICE COULD NOT BE ADVANCED INTO THE PATIENT'S ESOPHAGUS. THE PHYSICIAN ATTEMPTED A JAW THRUST AND APPLIED EXTRA LUBE TO THE DEVICE BUT WAS STILL UNSUCCESSFUL. THEN, THE PHYSICIAN ATTEMPTED TO USE AN OVERTUBE DEVICE AND SAW A PERFORATION IN THE PATIENT'S ESOPHAGUS BELIEVED TO BE CAUSED BY THE OVERSTITCH NXT AND ABORTED THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE ICU. AFTER 3 NIGHTS IN THE HOSPITAL, THE PATIENT WAS DISCHARGED.

  Patient problems: Perforation

  MAUDE report 22872867 ↗
• InjuryJul 11, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE OVERSTITCH NXT DEVICE COULD NOT BE ADVANCED INTO THE ESOPHAGUS. A DIAGNOSTIC SCOPE WAS THEN USED, WHICH REVEALED A PERFORATION JUST BELOW THE UPPER ESOPHAGEAL SPHINCTER (UES). THE PERFORATION WAS PARTIALLY CLOSED, AND THE ORIGINAL PROCEDURE WAS CANCELLED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION, AND TWO CT SCANS WERE PERFORMED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Perforation of Esophagus

  MAUDE report 22480861 ↗