Coated VICRYL J333HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031038912), received between Jan 9, 2020 and Sep 9, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A SURGERY FOR ARTIFICIAL HEAD, WHEN HELD THE NEEDLE, THE SUTURE WAS DETACHED, AND ALSO THE SUTURE WAS SNAPPED DURING USE, SO IT COULD NOT BE USED. THE CUSTOMER WOULD LIKE A REPLACEMENT AND A REPORT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004745 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SPAY PROCEDURE, THEIR INCISIONS COMPLETELY OPEN UP AT HOME TO THE POINT OF THEIR INSIDES COMING OUT. SWELLING, DISCHARGE, CHANGING BELLY BANDAGE DAILY FOR 3 DAYS CAN SEEN. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 22371315 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A SPAY PROCEDURE, INCISIONS COMPLETELY OPEN UP AT HOME TO THE POINT OF THEIR INSIDES COMING OUT. DEHISCENCE, OMENTUM EXPOSED, WENT BACK IN TO SURGERY TO RECLOSE. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22371219 ↗
• MalfunctionDec 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS BROKEN DURING USE. THE DOCTOR SAID THE NEEDLE WAS BENT MORE EASILY THAN USUAL. NO PIECE FELL INTO THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919911 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE SUTURING PROCESS, THE NEEDLE BROKE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678250 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE STITCHING, THE THREAD BROKE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292704 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURES BROKE EASILY INTRAOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491864 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURES BROKE EASILY INTRAOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489511 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. WHEN THE DOCTOR WAS SUTURING, THE NEEDLE BROKE OFF. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876757 ↗
• MalfunctionMar 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING TYING, THE NEEDLE CAME LOOSE FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565458 ↗
• MalfunctionMar 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT NEEDLE TIP BROKE APPROXIMATELY 2-3MM. IT WAS ALSO REPORTED THAT THE NEEDLE WAS NOT FOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595506 ↗
• MalfunctionMar 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WERE MULTIPLE BREAKS OF SUTURE WHEN USED INTRAOPERATIVELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595444 ↗
• MalfunctionMar 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WERE MULTIPLE BREAKS OF SUTURE WHEN USED INTRAOPERATIVELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595420 ↗
• MalfunctionMar 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WERE MULTIPLE BREAKS OF SUTURE WHEN USED INTRAOPERATIVELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595379 ↗
• MalfunctionNov 3, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON AN UNKNOWN DATE; AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778008 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS EASY TO BREAK. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10534382 ↗
• MalfunctionSep 9, 2020Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507041 ↗
• MalfunctionJan 9, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A DOUBLE-ARMED SUTURE THOUGH IT SHOULD BE SINGLE-ARMED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571802 ↗