Coated VICRYL J497GRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10705031040625), received between Mar 14, 2019 and Feb 20, 2025 — classified as 11 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE FRAYED AND COME OFF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420446 ↗
• InjurySep 17, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, THE FACILITY HAS HAD ISSUES WITH PATIENTS WOUNDS OPENING WITH THE SUTURES DISSOLVING PREMATURELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20241883 ↗
• InjurySep 17, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, THE FACILITY HAS HAD ISSUES WITH PATIENTS WOUNDS OPENING WITH THE SUTURES DISSOLVING PREMATURELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20241882 ↗
• InjurySep 17, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, THE FACILITY HAS HAD ISSUES WITH PATIENTS WOUNDS OPENING WITH THE SUTURES DISSOLVING PREMATURELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20241880 ↗
• InjurySep 17, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, THE FACILITY HAS HAD ISSUES WITH PATIENTS WOUNDS OPENING WITH THE SUTURES DISSOLVING PREMATURELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20241833 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR ¿OUR CUSTOMER HAS BROUGHT TO OUR ATTENTION THAT THESE TWO SUTURES, WERE BREAKING WHEN USED. CUSTOMER STATES THAT THEY HAVE BEEN USING THIS BRAND FOR 10 YEARS AND THIS HAS NEVER HAPPENED BEFORE.¿ IT IS UNKNOWN IF THERE ANY PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124868 ↗
• MalfunctionAug 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2003 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE ACTUALLY CAME OFF THE THREAD . NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638705 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDER WENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE UPON THE ACTUAL CLOSURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509014 ↗
• InjuryAug 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDER WENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, A FEW DAYS AFTER CLOSURE, THE SUTURE BROKE, CAUSING THE EXCISION SITE TO OPEN UP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17509009 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDER WENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE UPON THE ACTUAL CLOSURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509007 ↗
• InjuryAug 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDER WENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, A FEW DAYS AFTER CLOSURE, THE SUTURE BROKE, CAUSING THE EXCISION SITE TO OPEN UP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17509004 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED REACTION AND DEHISCENCE. THE WOUNDS ARE DEVELOPING A COUPLE WEEKS POST-OP, WELL AFTER INFECTION WOULD BE LIKELY. THE PHYSICIAN REPORTED THEY ARE SEEING MORE FOLLOW UPS DAILY WITH CONTINUED SKIN BREAK DOWN AND NON-HEALING WOUNDS. THE PHYSICIAN REPORTED THEY HAVE DONE A ROOT CAUSE ANALYSIS AND CANNOT FIND ANY OTHER POSSIBILITY FOR THE CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Skin Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 11143093 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED REACTION AND DEHISCENCE. THE WOUNDS ARE DEVELOPING A COUPLE WEEKS POST-OP, WELL AFTER INFECTION WOULD BE LIKELY. THE PHYSICIAN REPORTED THEY ARE SEEING MORE FOLLOW UPS DAILY WITH CONTINUED SKIN BREAK DOWN AND NON-HEALING WOUNDS. THE PHYSICIAN REPORTED THEY HAVE DONE A ROOT CAUSE ANALYSIS AND CANNOT FIND ANY OTHER POSSIBILITY FOR THE CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Skin Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 11143002 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED REACTION AND DEHISCENCE. THE WOUNDS ARE DEVELOPING A COUPLE WEEKS POST-OP, WELL AFTER INFECTION WOULD BE LIKELY. THE PHYSICIAN REPORTED THEY ARE SEEING MORE FOLLOW UPS DAILY WITH CONTINUED SKIN BREAK DOWN AND NON-HEALING WOUNDS. THE PHYSICIAN REPORTED THEY HAVE DONE A ROOT CAUSE ANALYSIS AND CANNOT FIND ANY OTHER POSSIBILITY FOR THE CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Skin Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 11142891 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED REACTION AND DEHISCENCE. THE WOUNDS ARE DEVELOPING A COUPLE WEEKS POST-OP, WELL AFTER INFECTION WOULD BE LIKELY. THE PHYSICIAN REPORTED THEY ARE SEEING MORE FOLLOW UPS DAILY WITH CONTINUED SKIN BREAK DOWN AND NON-HEALING WOUNDS. THE PHYSICIAN REPORTED THEY HAVE DONE A ROOT CAUSE ANALYSIS AND CANNOT FIND ANY OTHER POSSIBILITY FOR THE CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Skin Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 11142651 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED REACTION AND DEHISCENCE. THE WOUNDS ARE DEVELOPING A COUPLE WEEKS POST-OP, WELL AFTER INFECTION WOULD BE LIKELY. THE PHYSICIAN REPORTED THEY ARE SEEING MORE FOLLOW UPS DAILY WITH CONTINUED SKIN BREAK DOWN AND NON-HEALING WOUNDS. THE PHYSICIAN REPORTED THEY HAVE DONE A ROOT CAUSE ANALYSIS AND CANNOT FIND ANY OTHER POSSIBILITY FOR THE CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Skin Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 11142629 ↗
• MalfunctionMar 5, 2020Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT DURING SURGERY; SUTURE NEEDLE SPLIT AT THE TIP OF THE NEEDLE AS PHYSICIAN STARTED TO SUTURE. NO XRAYS WERE TAKEN AS IT WAS NOTED THE ENTIRE SUTURE WAS INTACT, JUST SPLIT AT THE TIP. NO PIECES NEEDED TO BE RETRIEVED AND NO PIECES REMAINED IN THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9796205 ↗
• MalfunctionFeb 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702332 ↗
• MalfunctionFeb 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702330 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076074 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076072 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076071 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076070 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076067 ↗
• MalfunctionJun 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE FELL OFF THE SUTURE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684955 ↗