OverStitch NXT ™ M00505430Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191506060107), received between Apr 8, 2026 and Sep 16, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that an Overstitch NXT was used during an Endoscopic Sleeve Gastroplasty (ESG) procedure on (b)(6)2026. During the procedure, the cap began to slip off of the endoscope. The physician cinched the suture earlier than originally planned. The procedure was completed with another Overstitch NXT. There was no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785488 ↗
• InjuryAug 19, 2026Device-Device Incompatibility

  It was reported to Boston Scientific Corporation that an OverStitch NXT was used during an Esophagogastroduodenoscopy (EGD) stent placement procedure on (b)(6)2026. During the procedure, the device was caught on the stent. The stent and Overstitch were removed, and the case started over. The procedure was completed with a new Overstitch NXT. There was no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326212 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE ON (B)(6) 2026. DURING THE WITHDRAWAL OF THE DEVICE, IT WAS NOTED THAT THE ANCHOR EXCHANGE WAS DETACHED FROM THE ENDCAP. THE PROCEDURE WAS ALREADY COMPLETE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278251 ↗
• MalfunctionMay 21, 2026Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. AFTER SETTING UP THE DEVICE, THE ENDCAP ROTATED. AS A RESULT, THE ALIGNMENT TUBE WAS OUT OF SIGHT, AND THE VIEW OF THE NEEDLE DRIVER WAS PARTIALLY OBSTRUCTED. THE PROCEDURE WAS CANCELLED AFTER THE PATIENT WAS UNDER SEDATION. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247447 ↗
• MalfunctionApr 8, 2026Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING A STENT FIXATION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE NEEDLE SHAFT FAILED TO OPEN. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT DAMAGE TO THE PATIENT'S MUCOSA. A HEMOSTAT WAS USED TO OPEN THE NEEDLE SHAFT AND THE SUTURE WAS CUT. THE PROCEDURE WAS NOT COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824526 ↗