OverStitchRecalls & reported problems across all models

We found 3 models of OverStitch by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 100 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2025 and Sep 24, 2026 — classified as 37 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Break” (58 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

OverStitch recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 14, 2026Open, Classified

   Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

   Z-2961-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported OverStitch problems

OverStitch models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OverStitch™ M00505530

  Endoscopic tissue approximation device
  1 recall64 reports
• OverStitch™ M00505450

  Endoscopic tissue approximation device
  25 reports
• OverStitch™ M00505410

  Endoscopic suturing device for altering gastric anatomy for weight loss
  11 reports

Recent OverStitch adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break; Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that an Overstitch Endoscopic Suture System was used during a fistula closure procedure performed on (b)(6) 2026.During the procedure, the suture broke and the distal tip that is mounted onto the scope along with the catheter became loose. The procedure was completed with a different device. 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 50884200 ↗
• MalfunctionSep 15, 2026Material Integrity Problem; Activation Failure

  It was reported to Boston Scientific Corporation that an OverStitch Suture Cinch used during a procedure on an unknown date.It was reported that the cinch broke during deployment. The patient's condition at the conclusion of the procedure was reported to be stable.Additional clarification, including the procedural outcome, was requested from the customer; however, this information was not available from the account. Should any additional relevant information become available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768423 ↗
• InjurySep 4, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600380 ↗
• MalfunctionAug 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488967 ↗
• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488966 ↗
• MalfunctionAug 27, 2026Activation Failure

  It was reported to Boston Scientific Corporation that an OverStitch Suture Cinch was used during an ESG procedure performed on (b)(6) 2026.During the procedure, the cinch failed to deploy. The procedure was completed with another device of the same model. There was no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484012 ↗
• 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, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358883 ↗
• MalfunctionAug 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351138 ↗
• MalfunctionAug 19, 2026Unsealed Device Packaging

  It was reported to Boston Scientific Corporation that an Overstitch ESS was used during an Esophagogastroduodenoscopy (EGD) Stent Fixation procedure on (b)(6) 2026. Prior to the procedure, it was noticed that the sterile package seal was damaged upon opening the device box. The procedure was completed with a new Overstitch device. There was no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50320607 ↗
• 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 ↗
• MalfunctionAug 14, 2026Entrapment of Device; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50245616 ↗

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