Coated VICRYL VCP496GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031053779), received between Apr 17, 2020 and Jun 10, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. IT WAS RETRIEVED. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653653 ↗
• MalfunctionApr 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN THORACOTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHILE SUTURING SUBCUTANEOUSLY AS THE SUTURE DID NOT WITHSTAND THE TENSION OF THE TISSUE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9972916 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and