OverStitch™ M00505530Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00191506060046), received between Aug 8, 2025 and Sep 15, 2026 — classified as 36 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (42 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 20, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358883 ↗
• MalfunctionAug 10, 2026Adverse Event Without Identified Device or Use Problem

  This product was returned to the manufacturer without any report of performance issues or adverse patient effects. The returned device was analyzed and the Product Investigation revealed that the Cinch Wire was broken and the Cinch failed to deploy. See Block H11 for full investigation details.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193792 ↗
• InjuryJul 28, 2026Failure to Cut; Activation Failure

  It was reported to Boston Scientific that an OverStitch Suture Cinch was used in a procedure performed on (b)(6) 2026.During the procedure, the device exhibited a condition where the cinch was being deployed, and it did not release from tissue. The physician attempted to "crunch" the handle, but the wire mechanism was bent within the handle. The cinch should have severed the suture and released from tissue. The procedure was completed after an extended time with another product of the same model.The patient outcome following the procedure is currently unknown, and there was no report about patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50061121 ↗
• InjuryJul 28, 2026Break; Failure to Cut

  It was reported to Boston Scientific that a Suture Cinch was utilized during a esophageal stent fixation procedure on (b)(6) 2026.During the procedure, a fully covered metal stent was placed, and an OverStitch device was used to place the sutures. During the cinching process, the Suture Cinch handle broke and failed to cut the suture. The handle was intentionally broken, and a hemostat was used to pull the inner wire, allowing the cinch to be manually deployed and the suture to be released and cut. The procedure was completed using the original device without further complications.No patient complications were reported as a result of the event, and the patient fully recovered.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50050778 ↗
• MalfunctionJul 27, 2026Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50003186 ↗
• InjuryJul 13, 2026Activation Failure

  It was reported to Boston Scientific Corporation that an OverStitch Suture Cinch was used during a Per-Oral Plication of the Esophagus procedure performed on (b)(6) 2026.It was reported that during the procedure, the last cinch failed to deploy. To troubleshoot the issue, the physician broke the device handle and used wire cutters to access the internal metal wire. The wire was wrapped around a Kelly clamp multiple times and manually pulled, resulting in successful deployment of the cinch. The troubleshooting prolonged the procedure. Wire cutters and Kelly clamps were used during the troubleshooting process to complete the procedure.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25806680 ↗
• MalfunctionJul 10, 2026Break; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SUTURE CINCH WAS UTILIZED DURING A PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE STAFF ATTEMPTED TO DEPLOY THE CINCH AS NORMAL HOWEVER THE HANDLE OF THE CINCH BROKE AND THE CORD SNAPPED THAT CONTROLS THAT CUT WIRE. PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786517 ↗
• MalfunctionJul 8, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS UTILIZED DURING A PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE WIRE ON THE CINCH HANDLE BROKE WHILE THE CINCH WAS BEING CLOSED. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25745540 ↗
• MalfunctionJun 24, 2026Failure to Cut; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS UTILIZED DURING A DEFECT CLOSURE PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE CINCH WOULD NOT RELEASE AND SUTURE WOULD NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604250 ↗
• MalfunctionJun 15, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED DURING AN OVERSTITCH DEFECT CLOSURE PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH FAILED TO CUT THE SUTURE. THE PROCEDURE WAS COMPLETED WITH A NEW SUTURE AND CINCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498607 ↗
• InjuryJun 15, 2026Break; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS UTILIZED IN A COLONOSCOPY WITH ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE CINCH FAILED TO DEPLOY AS INTENDED DUE TO A BREAK IN THE CINCH WIRE. TO FACILITATE DEPLOYMENT, A KELLY CLAMP WAS ATTACHED TO THE CINCH WIRE AND MANUAL TRACTION WAS APPLIED, RESULTING IN SUCCESSFUL DEPLOYMENT OF THE CINCH. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498606 ↗
• InjuryJun 9, 2026Break; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SUTURE CINCH WAS UTILIZED DURING AN ENDOBARIATRIC PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF OBESITY. DURING THE PROCEDURE, THE SUTURE CINCH HANDLE BROKE DURING DEPLOYMENT. THE PHYSICIAN HAD TO BREAK THE CATHETER AND USE HEMOSTATS TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446845 ↗
• MalfunctionMay 29, 2026Break; Mechanical Problem; Activation Failure

  IT WAS REPORTED THAT AN OVERSTITCH NXT WAS USED IN THE STOMACH DURING A FISTULA CLOSURE PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, WHEN ATTEMPTING TO DEPLOY THE CINCH TO SECURE THE SUTURES, THE CINCH WIRE BROKE AT THE DISTAL END OF THE CATHETER. UPON INSPECTION, THE CINCH DID NOT FULLY CLOSE AND WAS UNABLE TO SECURE THE TWO PEEK COMPONENTS TOGETHER. THE DEVICE COULD NOT COMPLETE THE INTENDED CINCHING FUNCTION. AN ALTERNATIVE CLOSURE METHOD WAS ATTEMPTED USING X-TACK, AND A RESOLUTION 360 CLIP WAS SUBSEQUENTLY USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334361 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem; Activation Failure

  It was reported to Boston Scientific Corporation that a Suturing Cinch was utilized during a procedure on (b)(6) 2026. During the procedure, the Suturing Cinch failed to deploy as intended. The cinch was manually deployed. During the manual deployment process, the technician sustained a small cut to their hand that required only a band aid and no further medical intervention. The procedure was completed successfully using the original device. No patient complications were reported due to the event.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332563 ↗
• InjuryMay 29, 2026Break; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SUTURE CINCH WAS USED IN THE STOMACH DURING A STENT FIXATION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH WIRE BROKE AND AS A RESULT, THEY WERE UNABLE TO CUT THE SUTURE. THE CINCH WAS SUCCESSFULLY DEPLOYED WITH A HEMOSTAT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332557 ↗
• MalfunctionMay 28, 2026Break; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURING CINCH WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURING CINCH FAILED TO CUT THE SUTURE AND THEN THE HANDLE BROKE. SUTURE WAS CUT WITH ANOTHER SUTURE CINCH FROM A DIFFERENT LOT NUMBER. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325170 ↗
• MalfunctionMay 28, 2026Break; Failure to Cut

  (B)(6) 2026 - (B)(6). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURING CINCH WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURING CINCH FAILED TO CUT THE SUTURE AND THEN THE HANDLE BROKE. SUTURE WAS CUT WITH ANOTHER SUTURE CINCH FROM A DIFFERENT LOT NUMBER. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325166 ↗
• MalfunctionMay 28, 2026Break; Failure to Cut

  ***05/07/2026 - PHILLN1*** IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURING CINCH WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURING CINCH FAILED TO CUT THE SUTURE AND THEN THE HANDLE BROKE. SUTURE WAS CUT WITH ANOTHER SUTURE CINCH FROM A DIFFERENT LOT NUMBER. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325162 ↗
• MalfunctionMay 28, 2026Break; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURING CINCH WAS USED IN A PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURING CINCH FAILED TO CUT THE SUTURE AND THEN THE HANDLE BROKE. THE SUTURE WAS CUT WITH ANOTHER SUTURING CINCH FROM A DIFFERENT LOT NUMBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321790 ↗
• InjuryMay 28, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS UTILIZED IN AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF OBESITY. DURING THE 5TH SUTURE DURING THE PROCEDURE, THE TECH FIRED AS NORMAL, BUT THE INNER CINCH WIRE BROKE. THE TECH HAD TO USE A HEMOSTAT TO GRAB THE INNER WIRE AND FIRE MANUALLY RESULTING IN SUCCESSFUL DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE COMPLAINANT REPORTED THAT THE TERRITORY MANAGER OBSERVED THE TECHNICIAN REMOVING THE SAFETY AND HOLDING THE HANDLE OPEN WHILE THE PHYSICIAN TIGHTENED THE SUTURE, RATHER THAN WAITING UNTIL THE SUTURE WAS TIGHTENED TO REMOVE THE SAFETY AND FIRE THE DEVICE IN ONE CONTINUOUS MOTION. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), "REMOVE THE SAFETY SPACER FROM THE CINCH HANDLE WHILE MAINTAINING SUTURE TENSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25314147 ↗
• InjuryMay 26, 2026Break; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SUTURE CINCH WAS UTILIZED IN A ESG- ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF OBESITY. DURING THE PROCEDURE, THE SUTURE CINCH WAS DEPLOYED AND THE BEADED ROD GOT REINSERTED/ STUCK INTO THE CINCH PLUG. A RAT TOOTH WAS UTILIZED TO HOLD COUNTER TENSION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25286163 ↗
• InjuryMay 26, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS UTILIZED IN AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6), 2026, FOR WEIGHT LOSS. WHEN CINCHING DURING THE PROCEDURE, THE SUTURE WASN'T CUT DURING THE DEPLOYMENT PROCESS. THE HANDLE WAS MANUALLY BROKEN TO EXPOSE THE DEPLOYMENT WIRE; THE WIRE WAS GRABBED WITH KELLY CLAMPS AND PULLED TO CUT SUTURE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25286026 ↗
• InjuryMay 22, 2026Break; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OVERSTITCH SUTURE CINCHES WERE USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH FAILED TO DEPLOY DUE TO DETACHMENT OF THE BLUE SLIDER FROM THE INNER WIRE WITHIN THE HANDLE. THE PROCEDURE WAS COMPLETED AFTER MANUAL DEPLOYMENT OF THE CINCH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THIS IS THE SECOND OF TWO OVERSTITCH SUTURE CINCHES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257437 ↗