Coated VICRYL VCP946H (UDI 10705031079779)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031079779), received between Jul 2, 2025 and Mar 11, 2026 — classified as 4 malfunctions.

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

• MalfunctionMar 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT THE DOCTOR WAS USING THE OLD SUTURE AND THE IT RIPPED AWAY FROM THE NEEDLE WHILE THE DOCTOR WAS SEWING. THE SUTURE WAS RETRIEVED AND THE NEEDLE. THE STAFF STATED THAT THE SAME THING OCCURRED THE DAY BEFORE DURING THE SURGERY. IT WAS THE SECOND SIMILAR INCIDENT IN TWO DAYS. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570263 ↗
• MalfunctionMar 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT THE DOCTOR WAS USING THE OLD SUTURE AND THE IT RIPPED AWAY FROM THE NEEDLE WHILE THE DOCTOR WAS SEWING. THE SUTURE WAS RETRIEVED AND THE NEEDLE. THE STAFF STATED THAT THE SAME THING OCCURRED THE DAY BEFORE DURING THE SURGERY. IT WAS THE SECOND SIMILAR INCIDENT IN TWO DAYS. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570261 ↗
• MalfunctionJul 25, 2025Material Separation; Device Contaminated During Manufacture or Shipping; Material Separation; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY NOTICED A SMALL BLACK DOT AND IT CAME OFF THE NEEDLE OUT OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608756 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE NEEDLE BROKE. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383524 ↗