Coated VICRYL J317HRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705031038752), received between May 13, 2019 and Aug 24, 2026 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409743 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VAGINAL PROLAPSE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE HAS BECOME DETACHED FROM THE THREAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544720 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VAGINAL PROLAPSE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE HAS BECOME DETACHED FROM THE THREAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544712 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VAGINAL PROLAPSE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE HAS BECOME DETACHED FROM THE THREAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544711 ↗
• InjuryNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VAGINAL PROLAPSE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE HAS BECOME DETACHED FROM THE THREAD. THE NEEDLE REMAINS INSIDE THE PATIENT. AN X-RAY AND REOPERATION ARE REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23544710 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VAGINAL PROLAPSE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE HAS BECOME DETACHED FROM THE THREAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544709 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN DURING USE. NO PIECES FELL INTO THE PATIENT'S BODY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299554 ↗
• MalfunctionAug 25, 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 NEEDLE PULLED OFF INSIDE THE PATIENT'S BREAST. THERE WERE NO CONSEQUENCES FOR THE PATIENT. TO FIND THE NEEDLE, AN IMAGE INTENSIFIER WAS USED, WHICH GENERATED A LOSS OF TIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22885587 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTAL RECONSTRUCTION PROCEDURE ON 10-04- 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, TIP OF SUTURES BROKE OFF. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140957 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTAL RECONSTRUCTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, TIP OF SUTURES BROKE OFF. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140955 ↗
• MalfunctionMay 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SCRUB NURSE OPENED THE PACKAGING OF DEVICE*1EA, SHE FOUND BLACK SPOT ON NEEDLE. SO THEY USE THE OTHER DEVICE TO COMPLETE THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005314 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN DURING OPERATION. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695283 ↗
• InjuryNov 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE AT THE STRAND CRIMPING LEVEL. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE NEEDLE PIECE FELL INTO THE PATIENT. A SCAN WAS MADE THE NEXT DAY WHEN THE NEEDLE PIECE WAS VISIBLE. THE BROKEN PIECE WAS RETRIEVED DURING A RECOVERY 48 HOURS LATER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20621945 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166753 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WE HAD A SITUATION WHERE ONE 2-0 VICRYL BROKE OFF IN A PATIENT¿S ABDOMEN DURING THE OPERATION TODAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768754 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SLEEVE GASTRECTOMY, LYSIS OF ADHESIONS; ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO ETHICON NEEDLES FROM A COATED VICRYL® (POLYGLACTIN 910) SUTURE PACKAGE BROKE OFF IN SITE WHILE SUTURING. THE BROKEN FRAGMENTS WERE UNABLE TO BE RETRIEVED. PER POLICY, NO X-RAY WAS REQUIRED DUE TO SIZE OF SUTURING NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18758782 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SLEEVE GASTRECTOMY, LYSIS OF ADHESIONS; ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO ETHICON NEEDLES FROM A COATED VICRYL® (POLYGLACTIN 910) SUTURE PACKAGE BROKE OFF IN SITE WHILE SUTURING. THE BROKEN FRAGMENTS WERE UNABLE TO BE RETRIEVED. PER POLICY, NO X-RAY WAS REQUIRED DUE TO SIZE OF SUTURING NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18758779 ↗
• MalfunctionSep 20, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782836 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, PART OF THE NEEDLE BROKE IN PATIENT¿S POSTERIOR FOSSA CAVITY. SURGEON WAS ABLE TO LOCATE PIECE OF NEEDLE AND RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820940 ↗
• MalfunctionNov 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY FOR UTERINE PROLAPSE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT WAS USED FOR THE LEVATOR ANI MUSCLE, BUT THE NEEDLE WAS BROKEN AT THE SWAGE PART. THE BROKEN NEEDLE FELL INTO THE TISSUE AND COULD NOT BE REMOVED. AFTER X-RAY EXAMINATION, THE BROKEN NEEDLE WAS FOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875242 ↗
• MalfunctionJul 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE PART DURING SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032646 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. SUTURE NEEDLE BROKE OFF IN A PATIENT WHILE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219936 ↗
• MalfunctionNov 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAS DROPPED IN THE PATIENT WHEN THE SURGEON OPENED THE SUTURE PACKAGE. THE NEEDLE REMOVED FROM THE PATIENT BODY. PATIENT IS FINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759801 ↗
• MalfunctionOct 26, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, A SUTURE NEEDLE BROKE DURING REPAIR AFTER THE VAGINAL DELIVERY. THE BROKEN NEEDLE PIECE WAS FOUND WITHIN THE VAGINAL TISSUE WITH AN XRAY AND WAS REMOVED DURING THE SAME PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698170 ↗
• MalfunctionOct 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES DESWAGED. 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 12647271 ↗