Coated VICRYL D6284Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031026254), received between Dec 13, 2022 and Dec 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K022269); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP : TRANSABDOMINAL PREPERITONEAL APPROACH PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ALTHOUGH THE SURGEON DIDN¿T PUT MUCH TENSION ON THE PRODUCT, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. THE SURGEON DIDN'T FEEL LIKE THE NEEDLE WAS BROKEN. THE PART OF THE NEEDLE WAS ALREADY COLLECTED. A SILVER MATERIAL ADHERED TO THE STUMP OF THE SUTURE FROM WHICH THE NEEDLE CAME OFF. SINCE THE SILVER MATERIAL WAS ATTACHED TO THE STUMP OF THE SUTURE, AND THE NEEDLE THAT CAME OFF WAS COLLECTED, BUT THE SURGEON IS AFRAID THAT A PART OF THE PRODUCT MAY HAVE REMAINED IN THE ABDOMINAL CAVITY. THE PRODUCT WAS USED ON PERITONEUM. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973776 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc