Coated VICRYL J494GRecalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10705031040526), received between May 1, 2018 and Apr 7, 2026 — classified as 12 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Material Separation” (55 reports).

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 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CUSTOMER WAS SUTURING A PATIENT AND THEY WERE PUTTING A STITCH IN, THE NEEDLE CAME OFF THE SUTURE WHILE THE SUTURE WAS STILL IN THE PATIENT. 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 24805398 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC ENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE. THE CASE WAS COMPLETED BY RETRIEVING THE PIECES OF THE NEEDLE. THE SURGEON OPENED A NEW SUTURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072573 ↗
• InjuryDec 9, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PORT INSERTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE SUTURE DID NOT SEEM TO BE DISSOLVING, SKIN INFECTION RESULTED, TREATED WITH KEFLEX AND THE PORT THEN ERODED THROUGH THE SKIN. THESE ARE THE SAME SUTURES WE HAVE USED OVER THE PAST 13 YEARS WITH NO SUCH INCIDENT. I HAVE BEEN SEEING A LOT NOT DISSOLVING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23758294 ↗
• InjuryDec 9, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PORT INSERTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE SUTURE DID NOT SEEM TO BE DISSOLVING, SKIN INFECTION RESULTED, TREATED WITH KEFLEX AND THE PORT THEN ERODED THROUGH THE SKIN. THESE ARE THE SAME SUTURES WE HAVE USED OVER THE PAST 13 YEARS WITH NO SUCH INCIDENT. I HAVE BEEN SEEING A LOT NOT DISSOLVING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23758293 ↗
• InjuryDec 9, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PORT INSERTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE SUTURE DID NOT SEEM TO BE DISSOLVING, SKIN INFECTION RESULTED. THE PATIENT MAY HAVE BEEN TREATED WITH KEFLEX AND THE PORT MAY HAVE THEN ERODED THROUGH THE SKIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23758291 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE AND SUTURE WERE FOUND TO BE SEPARATE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700368 ↗
• MalfunctionJun 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE AND NEEDLE SEPARATED DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310993 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THIS EVENT WAS FOUND DURING PULLING THE SUTURE. THE SUTURE WAS FOUND TO BE BROKEN FOR FIRST STITCHING. HCP CHANGED A NEW SUTURE TO CONTINUE THE SURGERY. NO PATIENT IMPACT OR CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072593 ↗
• InjuryJan 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT HAD BEEN RECEIVING STITCHES WHEN THE SUTURE NEEDLE BROKE. THE PATIENT ENDED UP HAVING TO HAVE ADDITIONAL TREATMENT OUTSIDE OF THE FACILITY FOR THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21158136 ↗
• MalfunctionSep 20, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING PROCEDURE, IN THE CATH LAB, WHILE CLOSING INCISION IN CHEST, THE NEEDLE BROKE OFF THE SUTURE AND WENT INSIDE OF PATIENT. THEY USED A FLUOROSCOPY TO LOCATE THE NEEDLE AND REMOVE IT. CASE WAS COMPLETED BUT DELAYED 15 MINUTES. NO PATIENT HARM REPORTED. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265436 ↗
• MalfunctionMar 29, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE HEALTHCARE PROFESSIONAL REPORTED THAT THEY HAVE BEEN EXPERIENCING ISSUES WITH THE 5-0 VICRYL SUTURES, 4-0 VICRYL SUTURES, AND 5-0 NYLON. THE 5-0 AND 4-0 VICRYL SUTURES ARE RIPPING IN THE MIDDLE OF THE SUTURE AND THE NEEDLES ARE FALLING OFF. THE 5-0 NYLON NEEDLES ARE COMING IN IRREGULAR SIZES. THERE WAS NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006088 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SURGEON UNEXPECTEDLY BROKE THREE SUTURES. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839639 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGY PROCEDURE ON (B)(6)2024; AND A SUTURE WAS USED. THE SURGEON UNEXPECTEDLY BROKE THREE SUTURES. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839634 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SURGEON UNEXPECTEDLY BROKE THREE SUTURES. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839631 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS PARTIALLY BROKEN. THE SURGEON REPLACED IT WITH A NEW ONE AND COMPLETED THE SURGERY SAFELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091808 ↗
• MalfunctionAug 11, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. MATERIALS MANAGEMENT REPORTED THAT A SUTURE HAD BEEN OPENED IN THE OR WITH A BLUNT TIP THAT WAS UNABLE TO PENETRATE THE SKIN. THE SUTURE WAS PLACED TO THE SIDE DURING THE PROCEDURE AND ANOTHER SUTURE WAS OPENED FROM THE SAME LOT WITH NO ISSUES. THERE WAS NO DELAY IN SURGERY. NO FRAGMENTS WERE GENERATED. SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515751 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR PUNCTURED THE FIRST NEEDLE, THE NEEDLE AND THREAD SEPARATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257750 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR PUNCTURED THE FIRST NEEDLE, THE NEEDLE AND THREAD SEPARATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254672 ↗
• MalfunctionDec 1, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE QUALITY OF SUTURE WAS BAD. THE THREAD HAD SPLIT ENDS. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894365 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT RETURNED DUE TO AN ALLERGIC REACTION TO THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15409918 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT RETURNED DUE TO AN ALLERGIC REACTION TO THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15409916 ↗
• MalfunctionMay 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NECK PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THE NEEDLE WAS RETRIEVED FROM THE PATIENT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF THE 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 14496553 ↗
• MalfunctionApr 19, 2022Material Separation; Material Separation

  IT WAS REPORTED BY THE SALES REP THAT DURING THE COLOSTOMY TAKEDOWN, THE SUTURE DETACHED FROM THE NEEDLE AT THE SWAGE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141893 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DERMATOLOGY DEPARTMENT NOTED THE SUTURE AND THE NEEDLE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060641 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DERMATOLOGY DEPARTMENT NOTED THE SUTURE AND THE NEEDLE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060626 ↗

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