Coated VICRYL J486HRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031040397), received between May 24, 2021 and Feb 7, 2025 — classified as 1 injury, 20 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROGRAMMED CAESAREAN SECTION WITHOUT INTRAOPERATIVE COMPLICATIONS ON (B)(6) 2025 AND SUTURE WAS USED. MONITORING IN THE INTENSIVE CARE UNIT WAS UNCOMPLICATED. ON PROCEDURE DATE AT 1:30 A.M., THE SURGEON WAS CALLED TO THE EMERGENCY ROOM FOR BLEEDING. THE PATIENT WAS TAKEN BACK TO THE EMERGENCY OPERATING ROOM AND UNDERWENT REOPERATION WITH GENERAL ANAESTHESIA FOR EVISCERATION WITHOUT DIGESTIVE LESIONS AND IDENTIFICATION OF THE INCRIMINATING THREAD DURING SUTURING OF THE APONEUROSIS. THE THREAD IS CUT IN ITS CENTER, THE CORNER STITCHES ARE IN PLACE, NO TEAR IN THE APONEUROSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 21332198 ↗
• MalfunctionFeb 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD JUST DETACHED FROM THE NEEDLE WHEN DR. (B)(6)WAS USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757683 ↗
• MalfunctionFeb 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD JUST DETACHED FROM THE NEEDLE WHEN DR. VLOK WAS USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757673 ↗
• MalfunctionFeb 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD JUST DETACHED FROM THE NEEDLE WHEN (B)(6) DR. WAS USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757668 ↗
• MalfunctionFeb 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD JUST DETACHED FROM THE NEEDLE WHEN DR. VLOK WAS USING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757659 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT WAS STATED THAT THE BROKEN RATE IS ABOUT 30%. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15557881 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT WAS STATED THAT THE BROKEN RATE IS ABOUT 30%. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15557639 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392447 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392445 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392428 ↗
• MalfunctionAug 31, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392171 ↗
• MalfunctionAug 31, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392168 ↗
• MalfunctionAug 31, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392166 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336476 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON TIED THE SUTURE AND THE SUTURE BROKE. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041963 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON TIED THE SUTURE AND THE SUTURE BROKE. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041958 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT AN ORTHOPEDIC PROCEDURE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON TIED THE SUTURE AND THE SUTURE BROKE. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041955 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON TIED THE SUTURE AND THE SUTURE BROKE. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041953 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON TIED THE SUTURE AND THE SUTURE BROKE. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041952 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON TIED THE SUTURE AND THE SUTURE BROKE. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041945 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE IS EASY TO BREAK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871850 ↗