OverStitch Endoscopic Suturing SystemRecalls & reported problems across all models
Apollo Endosurgery, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 198
- Deaths reported
- 4
- Injuries reported
- 54
- Recalls
- 0
We found 4 models of OverStitch Endoscopic Suturing System by Apollo Endosurgery, Inc. in the FDA's device registry (GUDID). Together they are named in 198 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2017 and Sep 21, 2026 — classified as 4 deaths, 54 injuries, 140 malfunctions.
The most frequently reported specific device problem is “Break” (56 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. 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
Reports received per month, all models
Most reported OverStitch Endoscopic Suturing System problems
Device problems
- Break56
- Adverse Event Without Identified Device or Use Problem37
- Device-Device Incompatibility27
- Activation Failure24
- Material Twisted/Bent22
- Difficult to Remove19
- Detachment of Device or Device Component15
- Entrapment of Device13
Patient problems
- No Clinical Signs, Symptoms or Conditions139
- Perforation9
- Device Embedded In Tissue or Plaque8
- Pain6
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information5
- Patient Problem/Medical Problem5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
OverStitch Endoscopic Suturing System models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OverStitch Endoscopic Suturing System ESS-G02-160Instrument, Ligature Passing And Knot Tying4 deaths76 reports
- OverStitch Endoscopic Suturing System PLY-G02-020-APLSuture, Nonabsorbable, Synthetic, Polypropylene53 reports
- OverStitch Endoscopic Suturing System CNH-G01-000Instrument, Ligature Passing And Knot Tying48 reports
- OverStitch Endoscopic Suturing System THX-165-028Instrument, Ligature Passing And Knot Tying21 reports
Recent OverStitch Endoscopic Suturing System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845864 ↗InjurySep 21, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845081 ↗InjurySep 21, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844809 ↗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 ↗MalfunctionAug 13, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240193 ↗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 6, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161175 ↗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 ↗InjuryJul 27, 2026Activation Failure
It was reported to Boston Scientific Corporation that an OverStitch Suture Cinch was used during a stent fixation procedure performed in the stomach on (b)(6)2026. During the procedure, the cinch failed to deploy. The procedure was completed when the physician manually deployed the cinch. There was no patient complications reported as a result of this event.This is the second of two Suturing Cinches used in the same procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003185 ↗InjuryJul 27, 2026Activation Failure
It was reported to Boston Scientific Corporation that an OverStitch Suture Cinch was used during a stent fixation procedure on (b)(6) 2026. During the procedure, the cinch failed to deploy. The procedure was completed when the physician manually deployed the cinch. There was no patient complications reported as a result of this event.Note: This is the first of two Suturing Cinches used in the same procedure.***Additional Information received on 04 AUG 2026***The patient anatomy was the stomach and the indication for the procedure was prosthesis fixation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003178 ↗MalfunctionJul 17, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856048 ↗MalfunctionJul 16, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846211 ↗MalfunctionJul 15, 2026Failure to Align; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25827406 ↗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 ↗
Other Apollo Endosurgery, Inc. products
All Apollo Endosurgery, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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