Coated VICRYL J398HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031039582), received between Dec 10, 2024 and Apr 27, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE 5 TIMES WHILE USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000232 ↗
• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE 5 TIMES WHILE USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000122 ↗
• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE 5 TIMES WHILE USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000106 ↗
• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE 5 TIMES WHILE USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000049 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE 5 TIMES WHILE USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000007 ↗
• MalfunctionDec 10, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER THAT THE SUT VICRYL 3-0 FS-2 27" VIO 36CT NEEDLE BECAME DETACHED FROM SUTURE AND FELL INTO ABDOMEN, DOCTOR WAS ABLE TO RETRIEVE. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20890952 ↗