NA M00505550Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00191506049188), received between Mar 3, 2026 and Aug 13, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2962-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

  It was reported to Boston Scientific Corporation that a Suture Cinch - Long was used during an Endoscopic Sleeve Gastroplasty (ESG) procedure performed on (b)(6) 2026.During the procedure, the suture broke into 2 pieces off of the cinch catheter when applying tension before deploying. The procedure was completed with another Suture Cinch - Long of the same model.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 50244674 ↗
• InjuryJul 27, 2026Break; Failure to Cut; Activation Failure

  It was reported to Boston Scientific that a Suture Cinch was utilized during an Endoscopic Sleeve Gastroplasty (ESG) procedure on (b)(6) 2026 for the treatment of obesity.During the procedure, the Suture Cinch handle did not deploy the cinch. The staff attempted to manually break the handle to manually deploy it however it did not work, the cinch did not cut the suture. The procedure was completed with another of the same device. There were no patient complications as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50003540 ↗
• InjuryJul 6, 2026Break; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS UTILIZED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE HANDLE WAS CLOSED TO DEPLOY THE CINCH; HOWEVER, THE CINCH DID NOT DEPLOY. THE HANDLE BROKE, AND THE CINCH WIRE ALSO BROKE. THE NURSE USED A HEMOSTAT TO MANUALLY DEPLOY THE CINCH. THE PROCEDURE WAS SUCCESSFULLY 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 25719251 ↗
• InjuryJun 29, 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 GASTRIC PER-ORAL ENDOSCOPIC MYOTOMY (GPOEM) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SUTURE CINCH HANDLE FAILED. THE PEEK PLUG AND COLLAR CAME TOGETHER; HOWEVER, THE HANDLE'S CUTTING FUNCTION COULD NOT BE ACTIVATED. AS A TROUBLESHOOTING MEASURE, THE USER MANUALLY FIRED THE DEVICE AND COMPLETED THE CUT. THE PROCEDURE WAS SUCCESSFULLY 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 25650386 ↗
• InjuryJun 2, 2026Break; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SUTURE CINCH WAS UTILIZED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2026, FOR POLYP REMOVAL. DURING THE PROCEDURE, THE SUTURE CINCH WIRE BROKE WHILE THE TECHNICIAN WAS CLOSING THE HANDLE. THE STAFF HAD TO TROUBLESHOOT BY BREAKING THE HANDLE AND MANUALLY PULLING THE WIRE THE REST OF THE WAY WITH A CLAMP.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 25363980 ↗
• InjuryMay 28, 2026Break; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURING CINCH WAS USED IN AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF A COLONIC MASS. DURING THE PROCEDURE, THE SUTURING CINCH HANDLE SNAPPED UPON DEPLOYMENT AND THE CINCH WOULD NOT DEPLOY. TROUBLESHOOTING ATTEMPTS WERE MADE INCLUDING TRYING TO OPEN THE HANDLE AND JIGGLE IT. THE PHYSICIAN HAD TO CUT THE WIRE AND MANUALLY DEPLOY THE CINCH. 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 25321770 ↗
• InjuryMay 26, 2026Break; Failure to Cut; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS USED DURING A PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH WIRE BROKE AND FAILED TO DEPLOY AND CUT THE SUTURE. THE PROCEDURE WAS COMPLETED WHEN THE PHYSICIAN MANUALLY DEPLOYED THE CINCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25286025 ↗
• InjuryMay 25, 2026Break; Failure to Cut; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH WAS USED DURING A PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE CINCH WIRE BROKE AND FAILED TO DEPLOY AND CUT THE SUTURE. THE PROCEDURE WAS COMPLETED WHEN THE PHYSICIAN MANUALLY DEPLOYED THE CINCH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272645 ↗
• MalfunctionMar 3, 2026Break; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUTURE CINCH - LONG WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE FOURTH HELIX WAS STUCK IN THE SHEATH AND FAILED TO DEPLOY. THE CINCH ALSO FAILED TO DEPLOY AND THE WIRE BENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493268 ↗