Coated VICRYL VCP497H (UDI 10705031150058)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031150058), received between Apr 8, 2026 and Apr 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, HEAD OPERATING ROOM NURSE REPORTED THAT DURING THE USE OF VCP 497 3/0 VICRYL SUTURES (LOT NUMBER: XCBBTKFO) MULTIPLE TIMES NEEDLE DETACHED FROM THE SUTURE OR THE SUTURE BECAME FRAYED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817985 ↗
• MalfunctionApr 8, 2026Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, HEAD OPERATING ROOM NURSE REPORTED THAT DURING THE USE OF VCP 497 3/0 VICRYL SUTURES (LOT NUMBER: XCBBTKFO) MULTIPLE TIMES NEEDLE DETACHED FROM THE SUTURE OR THE SUTURE BECAME FRAYED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817984 ↗