Coated VICRYL J371HRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031039391), received between Jul 17, 2018 and Sep 1, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50544394 ↗
• MalfunctionJul 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD BROKE FROM THE NEEDLE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460231 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16127026 ↗
• MalfunctionMay 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346303 ↗
• MalfunctionMay 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346302 ↗
• MalfunctionMay 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346300 ↗
• MalfunctionDec 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING USE ON THE PATIENT THE TIP OF THE NEEDLE BROKE OFF WHEN CLOSING THE WOUND, PATIENT WAS X RAYED BUT NO EVIDENCE OF TIP OF NEEDLE FOUND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057651 ↗
• MalfunctionAug 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329231 ↗
• MalfunctionAug 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329228 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT C-SECTION SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE SEWING THE UTERUS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739869 ↗
• MalfunctionMar 7, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGICAL THREAD BROKE DURING SUTURE AT THE SURGICAL CENTER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426505 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SEWING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11148631 ↗
• MalfunctionApr 14, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT C-SECTION PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS OBSERVED TO BE BROKEN NEAR WHERE THE GRASPER WAS HOLDING THE NEEDLE. THE CASE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956508 ↗
• MalfunctionMar 17, 2020Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AT THE SWAGE AND DETACHED FROM THE NEEDLE AT THE SWAGE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY IN THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842208 ↗
• MalfunctionMar 17, 2020Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AT THE SWAGE AND DETACHED FROM THE NEEDLE AT THE SWAGE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY IN THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842175 ↗
• InjuryJul 26, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND DEHISCENCE, POSSIBLE EVISCERATION. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7723545 ↗
• InjuryJul 17, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CESAREAN SECTION ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND FOUND EVISCERATION CUT SUTURE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available

  MAUDE report 7694550 ↗