Coated VICRYL VCP311H (UDI 10705031149762)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031149762), received between May 19, 2025 and May 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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.

• MalfunctionMay 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. UPON TISSUE PENETRATION, THE THREAD AND NEEDLE ARE IMMEDIATELY SEPARATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAYS REPORTED. AFTER USING 2 PIECES, 34 PIECES WERE RECALLED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316152 ↗
• MalfunctionApr 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. UPON TISSUE PENETRATION, THE THREAD AND NEEDLE ARE IMMEDIATELY SEPARATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAYS REPORTED. AFTER USING 2 PIECES, 34 PIECES WERE RECALLED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044784 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AND THE SUTURE WAS BROKEN DURING THE USE OF SUTURE DURING SURGERY. IMMEDIATELY STOPPED USING IT AND REPLACED OTHER BRAND OF SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444548 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 11:30 AM, THE SURGEON FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHILE SUTURING THE PERITONEUM UNDER LAPAROSCOPY, AND THE NEEDLE FELL INTO THE ABDOMINAL CAVITY. THE SURGERY WAS IMMEDIATELY STOPPED AND THE DEPARTMENT HEAD WAS NOTIFIED. NEEDLE SEARCH WAS PERFORMED UNDER C-ARM FLUOROSCOPY, AND THE NEEDLE WAS REMOVED FROM THE ABDOMINAL CAVITY AT 12 O'CLOCK. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820328 ↗
• MalfunctionJun 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED WHEN USING THE SUTURE IN THE PROSTATECTOMY THE NEEDLE COMES DISASSEMBLED FROM THE SUTURE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125410 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THERE IS A RUPTURE OF THE VICRYL SUTURE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047974 ↗