Coated VICRYL D8582Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031030596), received between Jan 10, 2020 and Feb 18, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CONTROL RELEASE NEEDLE WAS DETACHED EASILY. ALL EIGHT NEEDLE-SUTURES HAVE BEEN USED, AND THEY ARE NEEDLES ONLY. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405623 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CONTROL RELEASE NEEDLE WAS DETACHED EASILY. ALL EIGHT NEEDLE-SUTURES HAVE BEEN USED, AND THEY ARE NEEDLES ONLY. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405028 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CONTROL RELEASE NEEDLE WAS DETACHED EASILY. ALL EIGHT NEEDLE-SUTURES HAVE BEEN USED, AND THEY ARE NEEDLES ONLY. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404915 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CONTROL RELEASE NEEDLE WAS DETACHED EASILY. ALL EIGHT NEEDLE-SUTURES HAVE BEEN USED, AND THEY ARE NEEDLES ONLY. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403976 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CONTROL RELEASE NEEDLE WAS DETACHED EASILY. ALL EIGHT NEEDLE-SUTURES HAVE BEEN USED, AND THEY ARE NEEDLES ONLY. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403566 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CONTROL RELEASE NEEDLE WAS DETACHED EASILY. ALL EIGHT NEEDLE-SUTURES HAVE BEEN USED, AND THEY ARE NEEDLES ONLY. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403451 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CONTROL RELEASE NEEDLE WAS DETACHED EASILY. ALL EIGHT NEEDLE-SUTURES HAVE BEEN USED, AND THEY ARE NEEDLES ONLY. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402926 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CONTROL RELEASE NEEDLE WAS DETACHED EASILY. ALL EIGHT NEEDLE-SUTURES HAVE BEEN USED, AND THEY ARE NEEDLES ONLY. IT WAS A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401309 ↗
• MalfunctionJan 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESAREAN SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING INTERRUPTED SUTURING ON THE UTERUS. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9577890 ↗