Coated VICRYL J946HRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031043671), received between Jun 21, 2018 and Mar 23, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT DURING THE OPEN HYSTERECTOMY PROCEDURE, THE SUTURE WAS BREAKING IN MULTIPLE PIECES. IT WAS THE STRANDS OF THE SUTURE THAT WERE BREAKING. NO PATIENT CONSEQUENCES AS THEY USED A DIFFERENT SUTURE TO FINISH THE PROCEDURE. DEVICES ARE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669159 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 0 VICRYL J946 WAS USED IN CLOSING FASCIA IN AN ADD ON CESAREAN SECTION WITH SURGEON. A PART OF THE NEEDLE BROKE OFF FROM THE MAIN NEEDLE AND SUTURE. IT WAS LOCATED BUT NEEDLE WAS THEN IN TWO PIECES. THEY SAID ITS HAPPENED A FEW TIMES. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS REPORTED.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238192 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 0 VICRYL J946 WAS USED IN CLOSING FASCIA IN AN ADD ON CESAREAN SECTION WITH SURGEON. A PART OF THE NEEDLE BROKE OFF FROM THE MAIN NEEDLE AND SUTURE. IT WAS LOCATED BUT NEEDLE WAS THEN IN TWO PIECES. THEY SAID ITS HAPPENED A FEW TIMES. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238183 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE CUSTOMER ENCOUNTERED 4 INSTANCES WHERE THE NEEDLE TIP BROKE OFF DURING SURGERY, SO THEY DECIDED TO PULL OUT ALL THE SUTURES FROM THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593314 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE CUSTOMER ENCOUNTERED 4 INSTANCES WHERE THE NEEDLE TIP BROKE OFF DURING SURGERY, SO THEY DECIDED TO PULL OUT ALL THE SUTURES FROM THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593276 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE CUSTOMER ENCOUNTERED 4 INSTANCES WHERE THE NEEDLE TIP BROKE OFF DURING SURGERY, SO THEY DECIDED TO PULL OUT ALL THE SUTURES FROM THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593261 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE CUSTOMER ENCOUNTERED 4 INSTANCES WHERE THE NEEDLE TIP BROKE OFF DURING SURGERY, SO THEY DECIDED TO PULL OUT ALL THE SUTURES FROM THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593251 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN EMERGENCY C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING USE, SUTURES NEEDLE TIP BROKE OFF WHILE TRYING TO CLOSE A BLEEDING UTERUS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583437 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN EMERGENCY C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING USE, SUTURES NEEDLE TIP BROKE OFF WHILE TRYING TO CLOSE A BLEEDING UTERUS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583434 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN EMERGENCY C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING USE, SUTURES NEEDLE TIP BROKE OFF WHILE TRYING TO CLOSE A BLEEDING UTERUS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583433 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN EMERGENCY C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING USE, SUTURES NEEDLE TIP BROKE OFF WHILE TRYING TO CLOSE A BLEEDING UTERUS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583430 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP, THAT DURING AN UNKNOWN PROCEDURE, THEY WERE SEWING THE UTERINE, AND THE NEEDLE POPPED OFF. THEY OPENED ANOTHER AND THE SAME THING HAPPENED. THEY WENT THROUGH A TOTAL OF FOUR NEEDLES WHERE THE NEEDLE POPPED OFF. IT IS NOT A CONTROL RELEASE NEEDLE SO SHOULD NOT BE POPPING OFF. THEY DID NOT SAVE THE FOUR THAT WERE OPENED DURING THE PROCEDURE BUT THEY DO WANT TO SEND BACK THE STERILE SUTURES THAT ARE LEFT IN THE SAME BOX. SALES REP HAD OPENED ANOTHER TWO FROM THE SAME BOX FOR A "MOCK" EXAMPLE AND THEY WERE THE SAME WAY. NO PATIENT HARM AND CASE WAS ABLE TO BE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20644341 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP, THAT DURING AN UNKNOWN PROCEDURE, THEY WERE SEWING THE UTERINE, AND THE NEEDLE POPPED OFF. THEY OPENED ANOTHER AND THE SAME THING HAPPENED. THEY WENT THROUGH A TOTAL OF FOUR NEEDLES WHERE THE NEEDLE POPPED OFF. IT IS NOT A CONTROL RELEASE NEEDLE SO SHOULD NOT BE POPPING OFF. THEY DID NOT SAVE THE FOUR THAT WERE OPENED DURING THE PROCEDURE BUT THEY DO WANT TO SEND BACK THE STERILE SUTURES THAT ARE LEFT IN THE SAME BOX. SALES REP HAD OPENED ANOTHER TWO FROM THE SAME BOX FOR A "MOCK" EXAMPLE AND THEY WERE THE SAME WAY. NO PATIENT HARM AND CASE WAS ABLE TO BE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642666 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP, THAT DURING AN UNKNOWN PROCEDURE, THEY WERE SEWING THE UTERINE, AND THE NEEDLE POPPED OFF. THEY OPENED ANOTHER AND THE SAME THING HAPPENED. THEY WENT THROUGH A TOTAL OF FOUR NEEDLES WHERE THE NEEDLE POPPED OFF. IT IS NOT A CONTROL RELEASE NEEDLE SO SHOULD NOT BE POPPING OFF. THEY DID NOT SAVE THE FOUR THAT WERE OPENED DURING THE PROCEDURE BUT THEY DO WANT TO SEND BACK THE STERILE SUTURES THAT ARE LEFT IN THE SAME BOX. SALES REP HAD OPENED ANOTHER TWO FROM THE SAME BOX FOR A "MOCK" EXAMPLE AND THEY WERE THE SAME WAY. NO PATIENT HARM AND CASE WAS ABLE TO BE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642596 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP, THAT DURING AN UNKNOWN PROCEDURE, THEY WERE SEWING THE UTERINE, AND THE NEEDLE POPPED OFF. THEY OPENED ANOTHER AND THE SAME THING HAPPENED. THEY WENT THROUGH A TOTAL OF FOUR NEEDLES WHERE THE NEEDLE POPPED OFF. IT IS NOT A CONTROL RELEASE NEEDLE SO SHOULD NOT BE POPPING OFF. THEY DID NOT SAVE THE FOUR THAT WERE OPENED DURING THE PROCEDURE BUT THEY DO WANT TO SEND BACK THE STERILE SUTURES THAT ARE LEFT IN THE SAME BOX. SALES REP HAD OPENED ANOTHER TWO FROM THE SAME BOX FOR A "MOCK" EXAMPLE AND THEY WERE THE SAME WAY. NO PATIENT HARM AND CASE WAS ABLE TO BE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642420 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN MYOMECTOMY PROCEDURE (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP REPORTED THE NEEDLE BROKE OFF WHILE SUTURING THE UTERUS. FRAGMENT/NEEDLE WAS REMOVED FROM PATIENT WITHOUT HARM. CASE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18285395 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY BILATERAL SALPINGECTOMY WITH CYSTOSCOPY PROCEDURE ON 24-OCT-2023 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE NEEDLE BROKE WHILE SUTURING UNKNOWN TISSUE. THERE WAS NO INDICATION THAT AN X-RAY WAS NEEDED TO FIND THE FRAGMENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192022 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE IN (B)(6) 2023 AND FIGURE OF EIGHT SUTURE WAS USED ON THE VAGINAL CUFF. THE PATIENT EXPERIENCED A VAGINAL CUFF DEHISCENCE. THE PATIENT WAS TAKEN BACK TO SURGERY AND THE CUFF WAS CLOSED LAPAROSCOPICALLY ON (B)(6) 2023 OR IN OCTOBER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17950193 ↗
• MalfunctionAug 7, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR THAT A DEFECT EVENT OCCURRED IN THE BIRTH CENTER - WHILE IN USE THE NEEDLE BROKE AND THE SUTURE WAS PULLED RIGHT OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477318 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15512071 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509344 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509226 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509087 ↗
• MalfunctionAug 24, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE INTO TWO PIECES AT BASE, WHILE SEWING FASCIA. PHYSICIAN REPORTS NO ROUGH USE, JUST NORMAL PRACTICE. SUTURE WAS FOUND AND REMOVED FROM BODY. REST OF BOX THROWN AWAY. THE UTERINE INCISION WAS REPAIRED WITH 0 VICRYL IN A RUNNING LOCKED FASHION. A SECOND LAYER OF 0 MONOCRYL WAS USED TO OBTAIN EXCELLENT HEMOSTASIS. THE UTERUS WAS INSPECTED AND FOUND TO BE HEMOSTATIC. THE RECTUS MUSCLES AND INTERNAL ASPECT OF THE FASCIA WERE INSPECTED, AND HEMOSTASIS WAS ASSURED. THE FASCIA WAS REAPPROXIMATED WITH TWO RUNNING AND OVERLAPPING 0 VICRYL SUTURES. THE SUBCUTANEOUS TISSUE WAS REAPPROXIMATED WITH 3-0 VICRYL. THE SKIN WAS CLOSED WITH 4-0 VICRYL SUBCUTICULARLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283581 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANTERIOR AND POSTERIOR VAGINAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF. IT IS UNKNOWN IF ANYTHING FELL INTO THE PATIENT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NOTHING WILL BE RETURNED. PATIENT HARM WAS UNKNOWN AT THE TIME OF THE CALL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141889 ↗