Coated VICRYL VCP398H (UDI 10705031078130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031078130), received between Dec 15, 2025 and Dec 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE VETERINARIAN WAS PERFORMED THE SUTURE TO CLOSE THE BELLY OF THE CAT DURING THE OVARIECTOMY, THE NEEDLE PULLED OFF THE STRAND WITHOUT ANY EXCESSIVE TENSION. USE OF ANOTHER DEVICE FROM THE SAME BOX WITHOUT ANY PATIENT CONSEQUENCE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810087 ↗
• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE VETERINARIAN WAS PERFORMED THE SUTURE TO CLOSE THE BELLY OF THE CAT DURING THE OVARIECTOMY, THE NEEDLE PULLED OFF THE STRAND WITHOUT ANY EXCESSIVE TENSION. USE OF ANOTHER DEVICE FROM THE SAME BOX WITHOUT ANY PATIENT CONSEQUENCE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810082 ↗