Coated VICRYL VCP346H (UDI 10705031077812)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031077812), received between Dec 18, 2025 and Aug 27, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  It was reported that a patient underwent a robotic BSO procedure on an unknown date and suture was used. During a robotic (BSO) procedure, the physician was using an O Vicryl suture when the needle snapped in half. All portions of the broken needle were successfully retrieved. The physician also stated that this issue has occurred multiple times with the same suture while using minimal pressure. No patient consequences were reported. Device return status was not provided. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483373 ↗
• MalfunctionAug 27, 2026Break

  It was reported that a patient underwent a robotic BSO procedure on (b)(6)2026 and suture was used. During a robotic (BSO) procedure, the physician was using an O Vicryl suture when the needle snapped in half. All portions of the broken needle were successfully retrieved. The physician also stated that this issue has occurred multiple times with the same suture while using minimal pressure. No patient consequences were reported. Device return status was not provided. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483371 ↗
• MalfunctionApr 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHILE USING A NEEDLE TO SUTURE AN INCISION FOR A PATIENT, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776432 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION UNDER CONTINUOUS HARD ANESTHESIA ON (B)(6)2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430522 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403247 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838808 ↗