Coated VICRYL J212HRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031038196), received between Dec 3, 2019 and Jun 12, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL ORCHEDOPEXY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHILE PULLING IT DURING THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196014 ↗
• MalfunctionDec 13, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SCRUB NURSE NOTED THAT WHEN ARMING THE ¿SINGLE ARM SUTURE¿ THE PACKAGE ACTUALLY HAD ANOTHER NEEDLE ATTACHED MAKING IT A ¿DOUBLE ARMED SUTURE¿ WHEN IT WASN¿T SUPPOSED TO BE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924292 ↗
• MalfunctionSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CIRCUMCISION PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THREAD SEPARATION FROM THE NEEDLE IN CIRCUMCISION CASES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241814 ↗
• MalfunctionSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CIRCUMCISION PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THREAD SEPARATION FROM THE NEEDLE IN CIRCUMCISION CASES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241723 ↗
• MalfunctionSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CIRCUMCISION PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THREAD SEPARATION FROM THE NEEDLE IN CIRCUMCISION CASES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241711 ↗
• MalfunctionMay 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CIRCUMCISION PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE THREAD SEPARATED FROM THE NEEDLE DURING SUTURING IN CIRCUMCISION CASES. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277317 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(4) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, ONE PIECE BROKE WHILE PULLING GENTLY DURING STITCHING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857454 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 SUTURES FROM THE SAME BATCH BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107301 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 SUTURES FROM THE SAME BATCH BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107299 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 SUTURES FROM THE SAME BATCH BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107297 ↗
• MalfunctionDec 3, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHROURETERECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS FRAYING AND CUTTING THROUGH TISSUE LIKE BARBS. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405445 ↗
• MalfunctionDec 3, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHROURETERECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS FRAYING AND CUTTING THROUGH TISSUE LIKE BARBS. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405423 ↗
• MalfunctionDec 3, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHROURETERECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS FRAYING AND CUTTING THROUGH TISSUE LIKE BARBS. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405396 ↗
• MalfunctionDec 3, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHROURETERECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS FRAYING AND CUTTING THROUGH TISSUE LIKE BARBS. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405352 ↗
• MalfunctionDec 3, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS FRAYING AND CUTTING THROUGH THE TISSUE LIKE BARBS. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401463 ↗
• MalfunctionDec 3, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS FRAYING AND CUTTING THROUGH THE TISSUE LIKE BARBS. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401442 ↗
• MalfunctionDec 3, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS FRAYING AND CUTTING THROUGH THE TISSUE LIKE BARBS. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401441 ↗