OverStitch™ M00505410Recalls & reported problems
Boston Scientific Corporation · Endoscopic Suturing System · Class 2
All models of OverStitch (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00191506060091), received between Apr 16, 2026 and Sep 24, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent4
- Device-Device Incompatibility3
- Break2
- Detachment of Device or Device Component2
- Material Integrity Problem2
- Entrapment of Device1
- Failure to Align1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, 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 ↗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 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 14, 2026Entrapment of Device; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245616 ↗MalfunctionAug 7, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50171838 ↗MalfunctionJul 28, 2026Material Twisted/Bent
It was reported to Boston Scientific Corporation that an Overstitch ESS was used to treat a fistula in the colon during a flexible sigmoidoscopy procedure on (b)(6) 2026.During the procedure, the needle shaft was bent and could not connect to the anchor. 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 50050919 ↗MalfunctionJul 9, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765589 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ESS WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED BY THE PHYSICIAN THAT THE ALIGNMENT TUBE WAS DETACHED FROM THE ENDCAP OF THE DEVICE. AN ALTERNATIVE OVERSTITCH HANDLE WAS UTILIZED TO PROCEED WITH THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222645 ↗MalfunctionMay 12, 2026Break; Device-Device Incompatibility
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ESS WAS USED DURING A PROCEDURE ON (B)(6). DURING THE PROCEDURE, THE HANDLE BROKE AND THE ANCHOR FAILED TO TRANSFER. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25156231 ↗MalfunctionApr 16, 2026Failure to Align; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED IN THE ESOPHAGUS DURING A STENT FIXATION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE NEEDLE SHAFT WAS BENT AND WOULD NOT ALIGN WITH THE ANCHOR. THE ANCHOR EXCHANGE FAILED TO LOAD THE ANCHOR ONTO THE NEEDLE BODY. THEY PHYSICIAN TRIED TO USE A NEW SUTURE BUT WAS STILL UNSUCCESSFUL WITH LOADING THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH HANDLE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899163 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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