Coated VICRYL VCP945H (UDI 10705031079755)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031079755), received between Sep 19, 2025 and Sep 30, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948759 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHEN SUTURE WAS USED TO SUTURE FASCIA DURING SURGERY, THE SUTURE WAS BROKEN, AND THE SUTURE WAS CONTINUED AFTER A NEW SUTURE WAS REPLACED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148368 ↗
• MalfunctionDec 3, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY DUE TO "PLACENTAL ABRUPTION". WHEN SUTURING THE INCISION, THE SUTURE BROKE AFTER THE FIRST STITCH, AND THE SUTURE WAS IMMEDIATELY REPLACED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706979 ↗
• MalfunctionSep 19, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "CERVICAL EDEMA AND DYSTOCIA" AND UNDERWENT SURGERY IN THE EARLY MORNING OF THE NEXT DAY. WHEN PREPARING TO SEW THE WOUND FOR THE PATIENT DURING THE SURGERY, THE NURSE OPENED THE OUTER PACKAGING OF THE SUTURE AND FOUND THAT THE THICKNESS OF THE SUTURE WAS DIFFERENT. IMMEDIATELY REPLACED IT WITH A NEW ONE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095899 ↗