Coated VICRYL J518HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031040878), received between Nov 23, 2021 and May 4, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE CUSTOMER EXPERIENCED A DISCONNECTION WHILE USING THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068321 ↗
• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE CUSTOMER EXPERIENCED A DISCONNECTION WHILE USING THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068318 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN TRYING TO SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860869 ↗