Coated VICRYL J451HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031039995), received between Sep 25, 2019 and Jan 6, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE CAME OFF OF THE SUTURE WHILE THE SURGEON WAS CLOSING A SPAY PATIENT DURING A VET SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980316 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT NEEDLE KEEPS COMING OFF THE SUTURE - THEY HAD THE ISSUE WITH THIS ITEM BEFORE FROM A DIFFERENT DISTRIBUTOR (SAME MANUFACTURER) BUT NOW THEY JUST OPENED THIS BOX AND THE NEEDLE COMES OFF RIGHT AWAY. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794216 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT NEEDLE KEEPS COMING OFF THE SUTURE - THEY HAD THE ISSUE WITH THIS ITEM BEFORE FROM A DIFFERENT DISTRIBUTOR (SAME MANUFACTURER) BUT NOW THEY JUST OPENED THIS BOX AND THE NEEDLE COMES OFF RIGHT AWAY. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791337 ↗
• MalfunctionDec 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT NEEDLE DETACHED FROM SUTURE ON ONE SINGLE PACK. THERE IS NO ADVERSE REACTION TO THE PATIENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715025 ↗
• MalfunctionMay 30, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES WERE COMING OFF THE SUTURES AND ONE PACK WAS AFFECTED. CUSTOMER HAS THREE PACKS ALREADY FROM THIS BOX. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114495 ↗
• MalfunctionMay 30, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES WERE COMING OFF THE SUTURES AND ONE PACK WAS AFFECTED. CUSTOMER HAS THREE PACKS ALREADY FROM THIS BOX. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114494 ↗
• MalfunctionMay 30, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES WERE COMING OFF THE SUTURES AND ONE PACK WAS AFFECTED. CUSTOMER HAS THREE PACKS ALREADY FROM THIS BOX. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114492 ↗
• MalfunctionMay 30, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES WERE COMING OFF THE SUTURES AND ONE PACK WAS AFFECTED. CUSTOMER HAS THREE PACKS ALREADY FROM THIS BOX. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114491 ↗
• MalfunctionMay 30, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES WERE COMING OFF THE SUTURES AND ONE PACK WAS AFFECTED. CUSTOMER HAS THREE PACKS ALREADY FROM THIS BOX. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114488 ↗
• MalfunctionSep 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SEWING THE SKIN DURING THE CESAREAN SECTION, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10513456 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE WHILE TYING IT OFF. IT IS UNKNOWN WHERE THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9116441 ↗
• MalfunctionSep 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE AWAY FROM THE NEEDLE. IT IS UNKNOWN WHERE THE SUTURE BROKE AWAY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9115723 ↗