Coated VICRYL J356HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031039223), received between Oct 24, 2018 and Jan 10, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM SUTURE, AND A SECOND SUTURE WAS USED AND THE SAME ISSUE HAPPENED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND FRAGMENTS WERE NOT GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18488606 ↗
• MalfunctionJan 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM SUTURE, AND A SECOND SUTURE WAS USED AND THE SAME ISSUE HAPPENED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND FRAGMENTS WERE NOT GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18488587 ↗
• MalfunctionApr 22, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN INJURY OF FINGERS PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986659 ↗
• MalfunctionOct 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018, AND A SUTURE WAS USED. THE VICRYL SUTURE WAS CLAIMED TO NOT BE ABSORBING IN AN APPROPRIATE TIMELY MANOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8002408 ↗