Coated VICRYL VCP347H (UDI 10705031077829)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031077829), received between Nov 3, 2025 and Dec 11, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS CLOSING AN INCISION WHEN THE SUTURE BROKE. THE PRODUCT INVOLVED WAS VICRYL PLUS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778706 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC VAGINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE THE UTERUS WAS BEING SUTURED. NO FORCE WAS APPLIED. PART OF THE NEEDLE BECAME LODGED IN THE UTERINE WALL. IT WAS STATED THAT THERE WAS A SHARP FOREIGN OBJECT IN THE PATIENT'S ABDOMEN. THE SURGERY WAS DELAYED BY 10 MINUTES. IT WAS UNKNOWN OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23711516 ↗
• MalfunctionNov 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WE USED 5 BATCH VICRYL, AND IN ALL FIVE THE NEEDLE WAS BROKEN OR DEFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458058 ↗
• MalfunctionNov 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WE USED 5 BATCH VICRYL AND IN ALL FIVE THE NEEDLE WAS BROKEN OR DEFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457807 ↗
• MalfunctionNov 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WE USED 5 BATCH VICRYL *, AND IN ALL FIVE THE NEEDLE WAS BROKEN OR DEFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457687 ↗
• MalfunctionNov 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WE USED 5 BATCH VICRYL, AND IN ALL FIVE THE NEEDLE WAS BROKEN OR DEFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457682 ↗
• MalfunctionNov 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WE USED 5 BATCH VICRYL *, AND IN ALL FIVE THE NEEDLE WAS BROKEN OR DEFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457233 ↗