Coated VICRYL J344HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031039070), received between Jun 1, 2020 and Apr 9, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL SURGICAL REPAIR ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT EXPERIENCED A DEHISCENCE AND THE PATIENT REQUIRED SURGICAL REPAIR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24834773 ↗
• InjurySep 26, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVER ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE HAD BROKEN OFF CAUSING A SLIGHT VAGINAL TEAR LEADING THE PATIENT TO BE SENT TO OR TO REMOVE THE NEEDLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20315508 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FAILED, AND THE NEEDLE KEPT FALLING OFF WHEN IT WASN'T SUPPOSED TO. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534551 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FAILED, AND THE NEEDLE KEPT FALLING OFF WHEN IT WASN'T SUPPOSED TO. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534550 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FAILED, AND THE NEEDLE KEPT FALLING OFF WHEN IT WASN'T SUPPOSED TO. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534548 ↗
• MalfunctionAug 19, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING USE, THE SUTURE RIPPED BEFORE IT WAS EVEN FINISHED BEING TIED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10427929 ↗
• MalfunctionJun 1, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE JUNCTION WITH THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105783 ↗
• MalfunctionJun 1, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE JUNCTION WITH THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105781 ↗